Placebo Device Research Articles

Symptomatic treatment of mosquito bites with a thermo-therapeutic medical device: a prospective, intraindividual compared, placebo-controlled, randomized clinical trial

Objective: Agonizing itching (pruritus), heat, and burning are common symptoms of mosquito bites. In this study, we present a thermo-therapeutic medical device for the symptomatic treatment of mosquito bites. Current research suggests the potential of a thermal (heat) stimulus for pruriceptor counter-stimulation and reduced histamine-signaling to relieve the symptoms of mosquito bites. The purpose of this clinical investigation was to investigate the efficacy and safety of the thermo-therapeutic medical device (class II) in the symptomatic treatment of mosquito bites in an intraindividual comparison to a placebo device (PD) examined under standardized conditions. This was achieved by assessing pruritus and wheal size over time after induction of a mosquito bite on the volar forearm. Methods: The itching was rated on a Visual Analog Scale ranging from 0 mm (no itching) to 100 mm (worst imaginable itching). The wheal size was measured in approximation to the area of an eclipse before and ~30 minutes after the treatment with the investigational device. Local tolerability was assessed by the investigator according to a score ranging from 0 (no irritation) to 4 (very strong irritation) and the subjects stated if the itching sensation was completely gone after treatment (yes/no question). Results: The mean area under the curve of the difference to baseline for the treatment with the medical device was statistically significantly bigger than for the treatment with the PD (1311.71 vs 914.61, respectively; P = 0.0127). Conclusions: Treatment of a mosquito bite with a thermo-therapeutic medical device significantly reduced pruritus and led to a faster reduction of the itching sensation as compared with PD. A significant itch reduction started immediately (1 min) after treatment with the medical device (post hoc analysis). The treatment with the medical device was well tolerated by all subjects and no adverse events related to the medical device occurred.

Possibilities of non-drug treatment methods in the correction of dyslipidemia and manifestations of individual components of the metabolic syndrome

Aim of the study was to identify the place of low-intensity electro-pulse therapy with biofeedback when it is included in the rehabilitation complex of patients with abdominal obesity to correct the quality of life and individual components of the metabolic syndrome.Material and methods. In the conditions of the outpatient diagnostic center of City Clinical Hospital No. 2 of Novosibirsk, 60 men and women with abdominal obesity, arterial hypertension and insulin resistance were examined, divided into 3 groups: 1st (main group, n = 25) in addition for standard therapy received a 15-day course of dynamic electroneurostimulation (DENS) from the Neurodance-PCM device; the 2nd (comparison group 1, n = 20), in addition to the basic complex, received DENS procedures from a placebo device, the 3rd (comparison group 2, n = 15) was treated with the use of only a basic therapeutic complex. The control group included 17 men and women without clinical manifestations from the endocrine and cardiovascular systems. The examination included examinations by an endocrinologist, a nutritionist, anthropometry and bioimpedance, assessment of quality of life parameters.Results. In group 1 patients, 1 month after the start of rehabilitation, there was a greater tendency than in the comparison groups to decrease the body mass index by 9.0 %, a correction of the percentage content in the body structure of fat mass by 1.4 times (p = 0.029) occurred, preprandial glycemia decreased by 1.4 times (p = 0.043) and the level of triglycerides in the blood serum – by 1.4 times (p = 0.044), the increased concentration of free leptin and resistin decreased (1.2 times, p = 0.039), the content of adiponectin in the blood serum increased by 1.2 times (p = 0.041), the quality of life improved 1 month after the start of rehabilitation according to the components of physical and psychological health, which is not observed in the placebo and standard treatment groups.Conclusions. The inclusion of DENS from the Neurodance-PCM device in the comprehensive rehabilitation of patients with abdominal obesity can contribute to the correction of anthropometry, bioimpedance, carbohydrate and adipokine metabolism indicators. This makes it possible to recommend the inclusion of low-intensity electro-pulse therapy in complex rehabilitation for the correction of quality of life indicators and individual components of the metabolic syndrome.

The Optimal Learning Cocktail for Placebo Analgesia: A Randomized Controlled Trial Comparing Individual and Combined Techniques

This study investigated for the first time the effects of individual and combined application of 3 learning techniques (verbal suggestions, classical conditioning, and observational learning) on placebo analgesia and extinction.Healthy participants (N = 206) were assigned to 8 different groups in which they were taught through either a verbal suggestion, a conditioning paradigm, a video observing someone, or any combination thereof that a placebo device (inactive transcutaneous electric nerve stimulation [TENS]) was capable of alleviating heat pain, whereas one group did not (control). Placebo analgesia was quantified as the within-group difference in experienced pain when the placebo device was (sham) ‘activated’ or ‘inactivated’ during equal pain stimuli, and compared between groups.Placebo analgesia was induced in groups with 2 or 3 learning techniques. Significantly stronger placebo analgesia was induced in the combination of all 3 learning techniques as compared to the individual learning techniques or control condition, underlining the additional contribution of 3 combined techniques. Extinction did not differ between groups. Furthermore, pain expectancies, but not state anxiety or trust, mediated placebo analgesia.Our findings emphasize the added value of combining 3 learning techniques to optimally shape expectancies that lead to placebo analgesia, which can be used in experimental and clinical settings. PerspectiveThis unique experimental study compared the individual versus combined effects of 3 important ways of learning (verbal suggestions, classical conditioning, and observational learning) on expectation-based pain relief. The findings indicate that placebo effects occurring in clinical practice could be optimally strengthened if healthcare providers apply these techniques in combination.

Release of ranibizumab using a porous poly(dimethylsiloxane) capsule suppressed laser-induced choroidal neovascularization via the transscleral route

The administration of anti-vascular endothelial growth factor drugs in the posterior eye segment with sustained release through less invasive methods is a challenge in the treatment of age-related macular disease. We developed a flexible capsule device using porous poly(dimethylsiloxane) (PDMS) that was able to release ranibizumab. The porous PDMS sheet was fabricated by salt-leaching of a micro-sectioned PDMS sheet containing salt microparticles. Observation with scanning electron microscopy revealed that the pore densities could be adjusted by the concentration of salt. The in vitro release study showed that the release rate of fluorescein isothiocyanate-tagged albumin could be adjusted based on the pore density of the porous PDMS sheet. Ranibizumab could be released in a sustained-release manner for 16 weeks. The device was implanted on the sclera; its efficacy in terms of the suppression of laser-induced choroidal neovascularization (CNV) in rats was compared with that of monthly intravitreal injections of ranibizumab. At 8 and 18 weeks after implantation, the CNV area was significantly reduced in rats that received the ranibizumab-releasing device compared with those that received the placebo device. However, although monthly intravitreal injections of ranibizumab reduced CNV for 8 weeks, this reduction was not sustained for 18 weeks. In conclusion, we demonstrated a novel controlled-release device using a porous PDMS sheet that could suppress CNV via a less invasive transscleral route versus intravitreal injections. This device may also reduce the occurrence of side effects associated with frequent intravitreal injections.Graphical

Evaluation of Metered Dose Inhaler Use Technique and Response to Educational Training

Prescribing inhalers without imparting adequate education regarding proper technique of their usage may result in suboptimal clinical improvement and wastage of medication. Training interventions using a standard check-list may help improve faulty techniques and enhance drug efficacy. Patients using metered dose inhaler (MDI) were included in the study. Inhaler technique was first evaluated at baseline using a standard check-list of recommended steps (National Institute of Health guidelines; see Table) and scores were given for each step correctly performed. Those who could not perform all steps correctly were given training intervention. The patients were assigned to two methods of educational intervention; one group was trained by providing written material giving step-wise instructions while the other group was given an actual physical demonstration using a placebo device. The technique was re-evaluated and scored following each educational session, and continued till the patient achieved a full score, or for a maximum of 3 sessions, whichever occurred earlier. Median score was calculated after each session and was compared between the two groups. Each patient was followed up after two months and the re-evaluated the same way. One hundred and seventeen subjects were enrolled in the study (59 in the written group and 57 in the practical demonstration group). At baseline, only 1 of the 117 subjects could perform all the steps of inhaler usage correctly. This patient was, therefore, not provided the inhaler technique education. The overall median (range) score of the whole group was 3 (range 1-8). This score rose to 6, 7 and 8 after each of the three subsequent educational intervention sessions. At one-month follow-up, the median score dropped to 7 and improved with a repeat educational session as previously done. A significant difference was observed in the median score improvement achieved in the practical demonstration group compared with the written instruction group (3.0 versus 2.0 respectively, p < 0.001). Inhalation technique of patients improves after imparting systematic educational intervention. A practical demonstration of all the steps proved more effective than simple verbal/written advice. In view of increasing errors being committed over a period of time, repeated demonstration of the proper technique using a standard check-list significantly improves the errors committed during inhaler use.

P128 Double-blind randomized pilot study to evaluate diamagnetically enhanced transdermal ibuprofen in comparison to placebo on pain and function in individuals with knee osteoarthritis

Abstract Background/Aims Treatment of knee osteoarthritis (OA) focuses on reducing pain and improving function. Transdermal NSAID formulations have been developed as an alternative approach to reduce pain and sensitisation around the OA affected joint whilst avoiding some of the risks associated with oral NSAID administration. The aim of the study was to evaluate clinical outcomes following short-term (48 hours) administration of transdermal ibuprofen (5% w/v) from a wearable patch that incorporated a patented diamagnetic repulsion technology to enhance drug delivery, in comparison to placebo. Methods Double-blind, repeated measures, crossover design. Two study periods (48 hr each); diamagnetically enhanced ibuprofen or placebo, randomised. Participants: 24 (6 male: 18 female, mean age 66) people with painful knee OA. Patch applications: 6 x 4-5 hour patch applications over a 48 hour period. Active patches contained 5% ibuprofen in a gel reservoir with magnetized backing. Placebo patches had identical appearance but no ibuprofen and non-magnetized backing. Primary outcome measures: VAS for pain on movement (STS X3), WOMAC pain score, WOMAC function score. Results: Conclusion The active device containing ibuprofen (5%) and magnetophoresis technology produced a significantly greater reduction in pain and improvement in function than the placebo device. This was particularly the case for movement related pain. The reduction in pain was apparent with both VAS pain ratings and WOMAC pain score. There was also a clear improvement in function based on the WOMAC function score. The number needed to treat (NNT) for a 50% reduction in movement related pain was 2.2 and for resting pain 3.4. There were no major adverse events recorded during the study. Disclosure J. Summers: None. T. Wright: None. H. Benson: None. P. Moss: None. G. Tsadilas: None. J. Edwards: None. R. Will: None.

Adjunctive treatment of chronic migraine using an oral dental device: overview and results of a randomized placebo-controlled crossover study

ObjectiveTo assess the nocioceptive input of habitual nocturnal jaw clenching that acts as a contributing factor in migraine pathogenesis.BackgroundHabitual nocturnal jaw clenching has been implicated as a trigger, particularly in those whose headaches are present upon waking or shortly thereafter. Nocturnal EMG studies of patients diagnosed with migraine show nearly twice the temporalis clenching EMG levels and double the bite force as matched asymptomatic controls, leading to the speculation that parafunctional clenching activity may have some role in headache pathogenesis. The NTI (Nociceptive Trigeminal Inhibition) oral device is a dental splint designed to reduce nocturnal jaw clenching intensity and is FDA approved for the prevention of medically diagnosed migraine pain based on open label studies. There are no prior placebo-controlled trials to assess the migraine prevention efficacy of the NTI splint. This is the first placebo-controlled cross-over study to assess the efficacy of the NTI splint in patients with Chronic Migraine.MethodA placebo controlled, single-blinded cross-over study was done with IRB oversight assessing the efficacy of the NTI splint compared to placebo using the change in the HIT-6 score as the outcome measure.Results68% of refractory chronic migraine sufferers using the NTI as measured by sequential HIT 6 scores had at least a one-category improvement (severe to substantial, or substantial to some, or some to none) compared to 12% when using a placebo device. 36% of subjects using the NTI device reported a two-category improvement in their HIT-6 score, compared to 0% when using placebo.ConclusionThe improvement in HIT-6 scores produced by the NTI device, suggests that patients with Chronic Migraine may have intense nocturnal jaw clenching as a contributing factor to their headache related disability. An NTI device is one method of assessing whether jaw-clenching is a contributing factor to ongoing migraine.Trial registrationCurrent Controlled Trials NCT04871581. 04/05/2021. Retrospectively registered.

NSS-Bridge Device for Post-Cesarean Delivery Analgesia: A Randomized Controlled Trial.

Percutaneous auricular nerve stimulation has been used for the treatment of symptoms associated with opioid withdrawal, including abdominal pain, nausea, and general discomfort. However, its potential utility for pain management and opioid minimization after surgery has not been investigated. The purpose of this study was to test the feasibility and acceptability of a trial protocol designed to assess the effectiveness of the NSS2-Bridge device as a non-pharmacologic alternative to opioids after cesarean delivery. In a randomized control design, healthy women receiving cesarean delivery were randomized to receive the active device, placebo device, or no device. Devices were placed on the ear following cesarean delivery and left in place for 5 days. Feasibility and acceptability of the device was assessed by patient reports of device tolerability (rated on a 100mm visual analog scale where 0 is not tolerable at all and 100 is the most tolerable) as well as qualitative reporting. Additional outcomes assessed included proportion of patients not using opioids in hospital, as well as pain at rest, pain with movement, and total opioid consumption in the hospital and for the first 5 days after surgery. There were 60 patients included in the final analysis. Device tolerability was rated highly, with an average daily score of >75 mm on the visual analog scale. The trial retention rate was 89.7% with most exclusions (42.9%) occurring due to unanticipated development of care complexity (e.g., hemorrhage and additional surgical procedures), with only 1 exclusion (14.3%) due to device discomfort. The active device group achieved the highest proportion of opioid-free hospitalizations (40%) compared to placebo (20%) and no device groups (30%). Pain at rest and with movement was similar between treatment groups. This trial protocol designed to test the efficacy of NSS2-Bridge device for post-cesarean pain management is feasible and acceptable. Larger proportions of patients not using opioids in the active device group justifies additional investigation on device effectiveness in pregnant and postpartum people at highest risk for pain.

Transcranial magnet therapy in comprehensive therapy of migraine

To evaluate the effect of TMT on improving the effectiveness of comprehensive therapy in patients with migraine. A blind, randomized, placebo-controlled clinical trial was conducted, including 50 patients with migraine divided into three groups (the main group received TMT; the comparison group received low-frequency magnet therapy with a magnetic pulse duration of 250 μs; the control group received treatment with placebo device). The objectives were to study the TMT effect on reduction of the frequency and intensity of headache attacks, the severity of associated symptoms, reduction of medications use, including analgesics, in patients with migraine, as well as to evaluate the statistical difference in the effectiveness of magnetic therapy with different magnetic pulse ratio on all of the above parameters in study patients. According to the study data, a positive effect of TMT on the patients' condition was observed. After treatment, 76.9% of the patients in the main group had a reduction of headache intensity compared to the control group (35%) and a 47.8% decrease in analgesics use. In the main group, a reduction of nausea (73.3% of patients), acousticophobia (77.8% of patients), and photophobia (81.8% of patients) was noted. The HADS scale showed a 44.3% reduction in anxiety and depression in the main group. The clinical efficacy of TMT in patients with migraine has been demonstrated. In clinical practice, it is reasonable to use TMT to improve the treatment effectiveness in patients with migraine.

A Randomized Trial of Photobiomodulation Therapy for Center-Involved Diabetic Macular Edema with Good Visual Acuity (Protocol AE)

To determine if treatment with a photobiomodulation (PBM) device results in greater improvement in central subfield thickness (CST) than placebo in eyes with center-involved diabetic macular edema (CI-DME) and good vision. Phase 2 randomized clinical trial. Participants had CI-DME and visual acuity (VA) 20/25 or better in the study eye and were recruited from 23 clinical sites in the United States. One eye of each participant was randomly assigned 1:1 to a 670-nm light-emitting PBM eye patch or an identical device emitting broad-spectrum white light at low power. Treatment was applied for 90 seconds twice daily for 4 months. Change in CST on spectral-domain OCT at 4 months. From April 2019 to February 2020, 135 adults were randomly assigned to either PBM (n= 69) or placebo (n= 66); median age was 62 years, 37% were women, and 82% were White. The median device compliance was 92% with PBM and 95% with placebo. OCT CST increased from baseline to 4 months by a mean (SD) of 13 (53) μm in PBM eyes and 15 (57) μm in placebo eyes, with the mean difference (95% confidence interval [CI]) being-2 (-20 to 16) μm (P= 0.84). CI-DME, based on DRCR Retina Network sex- and machine-based thresholds, was present in 61 (90%) PBM eyes and 57 (86%) placebo eyes at 4 months (adjusted odds ratio [95% CI]= 1.30 (0.44-3.83); P= 0.63). VA decreased by a mean (SD) of-0.2 (5.5) letters and-0.6 (4.6) letters in the PBM and placebo groups, respectively (difference [95% CI]= 0.4 (-1.3 to 2.0) letters; P= 0.64). There were 8 adverse events possibly related to the PBM device and 2 adverse events possibly related to the placebo device. None were serious. PBM as given in this study, although safe and well-tolerated, was not found to be effective for the treatment of CI-DME in eyes with good vision.

Efficacy of photo bio-modulation therapy for pain relief and soft tissue wound healing after dental implant surgery: A double-blind randomized clinical trial

ObjectiveThis study aimed to investigate the effect of photo bio-modulation therapy (PBMT) on pain relief and wound healing after dental implant surgery. Background dataPhoto bio-modulation (PBM) has been used as a therapeutic method for the healing of wounds and controlling pain and inflammation. Materials and methodsIn this clinical trial, 21 patients including 12 men and 9 women were selected based on inclusion criteria. Forty-two implants were placed in the posterior regions of both sides of the mandible. Immediately after the surgery, 660 nm and 810 nm diode laser beams with an energy density of 6 J/cm2 were concurrently irradiated on three sides of the implant regions, buccal, occlusal, and lingual sides. After 48 h both two lasers were applied to patients without irradiation, as placebo devices in the control side. The severity of patients’ pain was examined after 12, 24, 48, and 72 h based on a visual analog scale (VAS). Wound healing score was also determined at 3, 7, and 14 days postoperatively using the Likert scale from 0 to 4. The data were analyzed with SPSS. Statistical significance was set at α = 0.05. ResultsThe laser side exhibited a significant improvement in wound healing and pain relief at all the intervals compared to baseline (p < 0.05). Wilcoxon test showed that the wound healing score on the laser side at 3 (p < 0.001), 7 (p < 0.001), and 14 (p = 0.03) days was significantly better than that on the placebo side. Paired t-test showed that at all the intervals of 12 h (p < 0.008), 24 h (p < 0.04), 48 h (p < 0.008), and 72 h (p < 0.02), the mean pain score on the laser side was significantly lower than that on the placebo side. ConclusionGiven the limitations of this study, the results showed that PBM enhanced wound healing and decreased pain after dental implant surgery.

A Study to Investigate the Prevalence of Device-Specific Errors in Inhaler Technique in Adults With Airway Disease (The SCORES Study): Protocol for a Single Visit Prevalence Study.

BackgroundIt is a recurring theme in clinical practice that patients using inhaled medications via an inhaler do not use their device to a standard that allows for optimum therapeutic effect, and some studies have shown that up to 90% of people do not use their inhalers properly. Observation and correction of the inhaler technique by health care professionals is advised by both national and international guidelines and should be performed at every opportunity to ensure that the optimum inhaler technique is achieved by the user. This study will provide a greater understanding of the most frequent technique errors made by people using 13 different inhaler types.ObjectiveThis study aims to identify and compare inhaler technique errors and their prevalence in adults, using device-specific checklists in accordance with manufacturers’ guidelines, for 13 specific inhaler types across all lung conditions and to correlate these errors with possible determinants of poor technique. It also aims to assess the error frequency at each step in the device-specific questionnaires and compare the error rates among device types.MethodsIn a single visit, participants using an inhaler included in the inclusion criteria will have their inhaler technique observed using an identical placebo device, which will be recorded using device-specific checklists, and technique-optimized, or switched to a suitable inhaler.ResultsThe study is already underway, and it is anticipated that the results will be available by 2022.ConclusionsThe SCORES (Study to Investigate the Prevalence of Device-Specific Errors in Inhaler Technique in Adults With Airway Disease) study will ascertain the prevalence of device-specific inhaler technique errors at each step in the device-specific checklists, compare error rates among 13 device types, and correlate these errors with possible determinants of poor technique. Future work will involve the clarification and classification of these errors into critical and noncritical categories.Trial RegistrationClinicalTrials.gov NCT04262271; https://clinicaltrials.gov/ct2/show/NCT04262271International Registered Report Identifier (IRRID)DERR1-10.2196/26350

Changes of biomechanics induced by Equistasi® in Parkinson's disease: coupling between balance and lower limb joints kinematics.

Axial disorders, including postural deformities, postural instability, and gait disturbances, are among the most disabling symptoms of Parkinson's disease (PD). Equistasi®, a wearable proprioceptive stabilizer device, has been proposed as neurological rehabilitative device for this set of symptoms. To investigate the effects of the device on gait and balance, 24 participants affected by PD were enrolled in this crossover double-dummy, randomized, controlled study. Subjects were assessed four times before and after 8weeks treatment with either active or placebo device; one-month wash-out was taken between treatments, in a 20-week timeframe. Gait analysis and instrumented Romberg test were performed with the aid of a sterofotogrammetric system and two force plates. Joint kinematics, spatiotemporal parameters of gait and center of pressure parameters were extracted. Paired T-test (p < 0.05) was adopted after evidence of normality to compare the variables across different acquisition sessions; Wilcoxon was adopted for non-normal distributions. Before and after the treatment with the active device, statistically significant improvements were observed in trunk flexion extension and in the ankle dorsi-plantarflexion. Regarding balance assessment, significant improvements were reported at the frequencies corresponding to vestibular system. These findings may open new possibilities on PD's rehabilitative interventions. Research question, tailored design of the study, experimental acquisition overview, main findings, and conclusions.

Apparatus physiotherapy in the treatment of rheumatic diseases

To evaluate the efficiency and safety of the ALMAG + magnetic therapy device in the treatment of osteoarthritis of the knee joints». The article presents preliminary data of a double-blind, placebo-controlled study «Evaluation of the efficacy and safety of the ALMAG + magnetic therapy device in the treatment of osteoarthritis of the knee joints». The study includes 70 patients (25 men, 45 women) of which 34 (48.6%) are patients with primary osteoarthritis (OA) of the knee joints (OAKS) and 36 (51.4%) are with secondary knee OA (on the background of immunoinflammatory rheumatic diseases). The patients were randomely divided into 2 groups: the main group (active devices) with 34 (48.6%) patients and the control group (placebo devices) - 36 (51.4%) patients. Patients of the main and control groups were comparable in all main parameters. During the study, the patients underwent 3 courses of treatment with the ALMAG + apparatus or with a placebo apparatus during the year. The preliminary analysis includes data on 58 patients who underwent at least 2 courses of therapy (28 patients from the main group and 30 from the control group). Pain at rest decreased in the main group by 4.0±2.9 mm, in the control group - by 1.07±2.21 mm (p=0.420), after the second course - by 5.13±3.4 and 1.81±2.19 mm (p=0.406), respectively. In the main group, the total WOMAC index decreased after the 1st course of physiotherapy from 24.0±14.9 to 20.25±14.31 mm (p=0.038), after the 2nd course it slightly increased - to 22.96±14.8 mm (p=0.314), in the control group the WOMAC index did not change statistically significantly: it decreased after the 1st course from 26.3±21.9 to 24.6±20.83 mm (p=0.112), after the 2nd course it increased to 27.04±21.9 mm (p=0.088). Thus, the use of the ALMAG + apparatus at home contributed to a decrease in pain at rest and a significant decrease in the WOMAC index in patients with primary and secondary OA of the knee joints. Pulsed magnetotherapy did not cause adverse events or exacerbation of immunoinflammatory diseases.

The MEMOWAVE project: A phase I/II clinical trial targeting treatment of mild cognitive impairment through sound stimulation during slow‐wave sleep

AbstractBackgroundMild Cognitive Impairment (MCI) is a highly prevalent syndrome especially among the elderly, but its treatment remains challenging. The MEMOWAVE project is a phase I/II randomized, double blind and cross‐over clinical trial. The first objective is to validate the safety and tolerance of a device consisting of a small microphone, also equipped with electroencephalographic electrodes, inserted in the external ear canals. The device produces pink noises during slow‐wave sleep based on real‐time EEG acquisition. The second objective is to investigate the effectiveness of this device in amplifying cerebral slow waves during sleep through sound emission. The third objective is to study the effect of this stimulation on memory consolidation, attention, executive functions, insight, creativity and mood in patients with MCI. Indeed, there is converging evidence that deep slow‐wave sleep plays a major role in these aspects. This process has already shown improvements in memory performance in healthy subjects and during normal aging.MethodTwenty‐four patients between 40 and 85 years of age will spend three nights in a Center for sleep disorders. Their cognitive functions, insight, creativity abilities and mood will be tested before and after a night of slow wave stimulation or placebo (device in place without stimulation), in a randomized and crossover fashion.ResultWe expect that this device will represent a simple therapeutic approach, easily tolerable by the patient, and able, if successful, of being offered quickly to a larger population of patients with MCI.ConclusionWe are proposing a new innovative methodology for the treatment of MCI which we are going to test for safety and efficacy.

A cool modality to restore sinus rhythm

Abstract Background Slowing electrical conduction by cooling the myocardium can be used for defibrillation. We previously demonstrated the efficacy of a small cold device placed in oblique sinus (OS) in terminating atrial fibrillation (AF). However, the parameters needed to achieve effective atrial defibrillation are unknown. Purpose Assess effect of the size of cooled myocardium on frequency of AF termination in acute canine animal models. Methods Sternotomy was performed under general anesthesia in 10 acute canine experiments. AF was induced using rapid atrial pacing and intra-myocardial epinephrine and acetylcholine injections. Once AF sustained for at least 30s, either a cool (7–9°C) or placebo (body temperature) device was placed in the OS. Four device sizes were tested; ½X½, ¾X¾, and 1X1 inch devices and two ¾X¾ inch devices placed side by side simultaneously. Time to AF termination was recorded. Chi-squared or Fisher's exact test were used to compare the frequency of arrhythmia termination with cooling versus placebo. Results A total of 166 applications were performed (89 cool vs 77 placebo) in 10 animal experiments. Overall, AF terminated in 82% of the cooling applications vs. 67.5% of placebo (P=0.03, Figure 1). For the ½X½ inch device 88% of cold applications restored sinus rhythm vs. 63.6% for placebo (P=0.05). The frequency of sinus restoration for cold ¾X¾, 1X1 and two ¾X¾ side by side devices was 86.7%, 83.3% and 70% respectively. Time to sinus restoration when achieved was within three minutes was also not significantly changed. Conclusion Placing a cool device in the oblique sinus can terminate AF and efficacy is not affected by the size of device. Funding Acknowledgement Type of funding source: Private grant(s) and/or Sponsorship. Main funding source(s): MediCool Technologies

General Practitioner Use of Generically Substitutable Inhaler Devices and the Impact of Training on Device Mastery and Maintenance of Correct Inhaler Technique.

IntroductionGeneric substitution of inhaler devices is a relatively new phenomenon. The best patient outcomes associated with generic substitution occur when prescribers obtain consent from their patients to prescribe a generic inhaler and also teach their patient how to correctly use the new device. To date, no prospective observational study has assessed the level of training required for general practitioners (GPs) to demonstrate correct inhaler technique using two dry powder inhaler devices delivering fixed-dose combination budesonide/formoterol therapy. This study aims to (1) determine the level of training required for GPs to master and maintain correct IT when using two different dry powder inhalers that are able to be substituted in clinical practice and (2) determine the number and types of errors made by GPs on each device and inhaler device preference at each training visit.MethodA randomized, parallel-group cross-over study design was used to compare the inhaler technique of participants with a Spiromax® placebo device and a Turbuhaler® placebo device. This study consisted of two visits with each participant over a period of 4 ± 1 weeks (visit 1 and visit 2). A total of six levels of assessment and five levels of training were implemented as required. Level 1, no instruction; level 2, following use of written instruction; level 3, following viewing of instructional video; level 4, expert tuition from the researcher; level 5/level 6, repeats of expert tuition from the researcher when required. Participants progressed through each level and stopped at the point at which they demonstrated device mastery. At each level, trained researchers assessed the inhaler technique of the participants. Participants were also surveyed about their previous inhaler use and training.ResultsIn total, 228 GPs participated in this study by demonstrating their ability to use a Turbuhaler® and a Spiromax® device. There was no significant difference between the proportion of participants who demonstrated device mastery with the Turbuhaler® compared with the Spiromax® at level 1, (no instruction), (119/228 (52%) versus 131/228 (57%), respectively, n = 228, p = 0.323 (McNemar’s test of paired data). All but one participant had demonstrated correct inhaler technique for both devices by level 3(instructional video). There was a significant difference between the proportion of participants who demonstrated maintenance of device mastery with the Turbuhaler® compared with the Spiromax® at visit 2, level 1 (127/177 (72%) versus 151/177 (85%) respectively, p = 0.003; McNemar’s test of paired data). All but two participants achieved device mastery by level 3, visit 2. More participants reported previous training with the Turbuhaler® than with Spiromax®.DiscussionThis study demonstrates that GPs are able to equally demonstrate correct use of the Turbuhaler® and Spiromax® devices, even though most had not received training on a Spiromax® device prior to this study. The significance of being able to demonstrate correct technique on these two devices equally has ramifications on practice and supported generic substitution of inhaler devices at the point of prescribing, as the most impactful measure a GP can take to ensure effective use of inhaled medicine is the correct demonstration of inhaler technique.Electronic supplementary materialThe online version of this article (10.1007/s41030-020-00131-8) contains supplementary material, which is available to authorized users.

Short Term Efficacy of Modified Epley’s Maneuvre Assisted by Visual Aid Dynamic Device Versus Unassisted Maneuvre for the Treatment of Posterior Canal BPPV

Introduction: Modified Epley’s maneuver is the recommended treatment for the Posterior Canal (PC) BPPV. To enhance the efficacy of this maneuver, an easy to perform visual aid device (DizzyFIX) guided modified Epley’s maneuver was studied. Material and Methods: This prospective, double-blind, randomized study included consecutive patients with PC-BPPV based on clinical history, neuro-otological examination, and positive Dix- Hallpike (DHP) test from January 2018 to March 2019 at a neurology clinic of western India. Patients were randomly assigned treatment with either visual aid device assisted modified Epley’s maneuver, which constituted the case group or by a placebo device guided modified Epley’s maneuver, which constituted the control group. DizzyFIX was used as a visual aid device in the case group. Patients were followed up at one hour and 24 hours with DHP by the blinded examiners to observe for remission. Results: Out of 280 patients (140 patients in each group), 6 from the case, and 2 from the controls were lost from the follow-up. Overall, 134 cases were compared to 138 controls. The success rate of remission in the case and the control group at one-hour was 79.19% vs. 48.30%, respectively, with a p-value of 0.003. Similarly, the success rate in the case and control group at 24 hours was 95.27% vs. 80.62%, respectively, with a p-value of 0.011. At 1 hour, unadjusted Odd Ratio (OR) was 4.13, (C.I. 95% 2.02- 8.46) and at 24 hours, it was 4.37, (C.I. 95% 1.39-13.77), which was significant even after adjustment of co-variables (OR 4.02, C.I. 95% 2.34- 8.26) and (OR 4.11, C.I. 95% 2.30- 14.26), respectively. Conclusion: For short term treatment of PC-BPPV, DizzyFIX assisted modified Epley’s maneuver is more efficacious than unassisted modified Epley’s maneuver.

Inhaler devices in asthma and COPD patients \u2013 a prospective cross-sectional study on inhaler preferences and error rates

BackgroundInhalation therapy is the backbone of asthma and COPD control. However, inhaler adherence and device mishandling continue to be a problem in real life. Some studies have shown that using a patient-preferred inhaler may reduce device handling errors and improve adherence to prescribed chronic inhaler drug therapy. The aim of this study was to compare the preferences for commonly used inhaler devices in Germany in patients with chronic obstructive respiratory disease. We also pursued the question which properties of an inhaler device are particularly important to the user and what effects age, gender and type of disease (asthma or COPD) may have on device preference and handling errors.MethodsProspective, open-label cross-sectional study in which 105 patients with asthma (58%) or COPD (42%) participated. Validated checklists were used to objectively assess inhaler technique and errors with 10 different placebo devices. For each device, patients were asked to test the handling, to assess the device properties and to name the device that they would most or least prefer.ResultsAcross the 10 placebo inhaler devices tested, patients needed an average of 1.22 attempts to error-free use. The device with the lowest mean number of attempts was the Turbohaler® (1.02), followed by the Nexthaler® (1.04), the Diskus® (1.07) and the Spiromax® (1.10). Patients over 60 years vs. younger age (p = 0.002) and COPD vs. asthma patients (p = 0.016) required more attempts to ensure correct use. 41% of the study participants chose one of the devices they already used as the most preferred inhaler. Overall, 20% opted for the Spiromax®, 15% for the Nexthaler® and 14% for the Turbohaler® or a pMDI. The least preferred device was the Elpenhaler® (0%). From a selection of 7 predefined inhaler attributes, patients stated easy handling as the most important for them. This was followed by short inhalation time and low inhalation resistance.ConclusionsPatient preference may vary between inhaler devices. The lowest number of attempts to error-free use was reported for the Turbohaler® and the Nexthaler®. The Spiromax® and the Nexthaler® achieved the best overall ratings and were the devices most preferred by patients.

Acute Effects Of Photobiomodulation Therapy On Muscle Force Recovery In Persons With Multiple Sclerosis

Symptomatic fatigue, as well as muscle fatigue, are common in persons with multiple sclerosis (PwMS), and both can negatively affect quality of life (QOL). Photobiomodulation Therapy (PBMT), comprising light in a 600-1000 nm bandwidth, is an emerging therapeutic modality thought to enhance mitochondrial function. There is evidence that PBMT can improve muscle fatigue, inflammation, and psychological status and thus might be beneficial for PwMS. PURPOSE: To investigate PBMT on muscle force recovery after a fatiguing contraction in PwMS. A secondary aim was to determine if self-reported symptom outcomes influenced the response to PBMT. METHODS: Randomized double-blinded repeated-measures design. Ambulatory males and females (n=17, 14 females) with relapsing-remitting MS were evaluated pre- and post-PBMT in 4 visits over 4 weeks. The muscle function measurements consisted of 3 maximal voluntary contractions (MVCs) of Tibialis Anterior (TA) muscle followed by 2 min. of intermittent isometric contraction at 45% MVC. PBMT was then administered to the TA muscle belly at 1 of 4 energies: 40J, 80J, 120J or placebo (active device: 3 pulsed wavelengths at the same time including 640nm, 875nm, and 905nm, placebo device: single pulsed wavelength at 640 nm). After PBMT, recovery MVC’s were obtained. Baseline psychosocial measurements comprising depression (CES-D), fatigue (MFIS) and QOL (PROMIS) were obtained during visit 1. McNemar’s test was used to test for each light dose compared to placebo and Spearman’s correlations were compared with Fisher’s r to z transformation. RESULTS: All subjects were able to recover strength to within 12% of their initial strength during the 120J visit. However, 6/17 subjects did not recover to the same degree after the placebo. This difference in force recovery between high (120J) dose and placebo was significant with p=0.03. Muscle recovery correlations with depression and QOL differed between 120J vs. Placebo (0.35 vs. -0.44, p=0.03 and -0.09 vs. 0.67, p=0.03, respectively). CONCLUSIONS: PBMT at 120J may improve muscle force recovery in PwMS. Those reporting greater depression, or lower QOL may benefit most from PBMT. Supported by a pilot grant from the National MS Society