Cranial Electrotherapy Stimulation Research Articles

Efficacy of cranial electrotherapy stimulation in patients with burning mouth syndrome: a randomized, controlled, double-blind pilot study.

The Burning mouth syndrome (BMS) is a chronic pain syndrome characterized by a burning sensation in the oral mucous membranes. The etiology and pathophysiology of BMS is largely unexplained. To date, there is no evidence-based treatment strategy for BMS. Cranial electrical stimulation (CES) represents a non-invasive treatment option with a low side effect profile that is approved for the treatment of pain, depression, anxiety disorder and insomnia. It has shown efficacy in studies for chronic pain such as fibromyalgia and neuropathic pain after spinal cord injury. This study aimed to investigate the therapeutic effectiveness of CES in combination with local transcutaneous electrical nerve stimulation (TENS) as an adjunct therapy in patients with BMS compared to sham stimulation. This randomized, double-blind, sham-controlled pilot study enrolled 22 patients, aged 18 years and over, with the diagnosis of BMS meeting the ICHD-3 criteria from August 2020 to June 2021. The study duration was 4 weeks (28 days) per participant. After randomization, the active group participants (n = 11) received a 100 μA CES treatment for 60 min a day whereas the devices in the Sham group did not emit electricity. Simple linear regression was used to determine whether the interventions promoted significant differences in pain intensity. The linear regression showed that the period of stimulation significantly predicted decrease in the intensity of pain in the active group [β = -0.036; t(26) = -7.219; p < 0.001] as in the sham group [β = -0.026; t(26) = -2.56; p < 0.017]. With the applied cutoff of 30% pain reduction within the stimulation period, both the active and sham groups had 36% responders (n = 4) (Fisher's exact test, p = 1.00). In both groups (active stimulation and sham group), a significant decrease in the intensity of pain, somatic symptoms and an improvement in sleep quality over the study period was observed. Subjects reported no adverse events during the study. Although CES is an easily applicable and safe therapeutic option for chronic facial pain, active stimulation was not superior to sham stimulation. Among other reasons, this could be due to the short double-blinded treatment period, duration of the daily stimulation session or the small sample size.

Effect of cranial electrotherapy stimulation (CES) in treatment of premature ejaculation: a randomized clinical trial

BackgroundPremature ejaculation is one of the most common male sexual dysfunction, affecting approximately 30% of men. The aim of this study is to evaluate the efficacy and at the same time the safety of the cranial electrotherapy stimulation (CES) device in treatment of premature ejaculation disorder.MethodsBased on a randomized clinical trial, two groups were included in the study, so that the first group was treated with sertraline along with an ATANG (AT-9 model) CES, and the second group with sertraline and inactive the CES device (as the placebo group). The state of premature ejaculation after treatment (using the Premature Ejaculation Diagnostic Tool (PEDT) questionnaire) was evaluated and compared for both groups.ResultsIn the intervention and placebo groups, the average score of the PEDT questionnaire before the intervention did not differ significantly between the two groups (p-value equal to 0.93). However, the average score of the PEDT questionnaire after the intervention for CES group and placebo group was 10.28 ± 1.93 and 13.23 ± 3.05, respectively, which demonstrated a significant decrease in the intervention group (p-value equal to 0.01).ConclusionThe use of CES device as a complementary treatment along with routine drug treatment (sertraline) is associated with a significant improvement in the condition of premature ejaculation of patients.Trial registrationName of the registry: IRCT Iranian Registry of Clinical Trials.Trial registration number: IRCT20210621051657N1.Date of registration: December 11, 2022.URL of trial registry record: https://en.irct.ir/trial/57201.

Balancing Act: Acute and Contextual Vestibular Sensations of Cranial Electrotherapy Stimulation Using Survey and Sensor Outcomes in a Non-Clinical Sample.

Cranial electrotherapy stimulation (CES) delivers low-intensity electrical currents to the brain to treat anxiety, depression, and pain. Though CES is considered safe and cost-effective, little is known about side effects emerging across different contexts. Our objective was to investigate how varying physical and cognitive demands impact the frequency and intensity of CES vestibular sensations in a sample of healthy young adults. We used a 2 (stimulation: sham, active) × 2 (physical demand: static sway, dynamic sit-to-stand) × 2 (cognitive demand: single-task remain silent, dual-task count backward) repeated measures design. Vestibular sensations were measured with surveys and wearable sensors capturing balance changes. Active stimulation did not influence reported vestibular sensations. Instead, high physical demand predicted more sensation reports. High cognitive demand, but not active stimulation, predicted postural sway unsteadiness. Significant effects of active stimulation on balance were observed only during the dynamic sit-to-stand transitions. In summary, CES induces vestibular sensations only for a specific outcome under certain circumstances. Our findings imply that consumers can safely maximize the benefits of CES while ensuring they are taking steps to minimize any potential side effects by considering their context and circumstances.

The effect of short-term cranial electrotherapy stimulation on sleep quality in athletes: A pilot study.

To verify the effect of a 5-day cranial electrotherapy stimulation (CES) intervention on sleep quality in professional athletes. 25 professional athletes with poor sleep quality participated in the study. Athletes belonging to the CES group (12 athletes) received a 5-day CES intervention, and those in the control group did not receive any intervention. Objectively and subjected assessed sleep quality was measured 1 week before and after the intervention using an Actigraphy activity recorder, Pittsburgh sleep quality index (PSQI), and Insomnia Severity Index (ISI). Objectively measured sleep efficiency increased after CES intervention (P = .013), while the difference between the pretest and posttest of the control group was not significant. For total sleep time (TST), the main effects and interaction were not significant. However, the analysis on wake after sleep onset showed wake after sleep onset decreased after CES intervention (P = .015). No significant interaction was found in subjectively assessed sleep quality but only revealed an improvement in both groups. The CES intervention of 30 minutes per day for 5 consecutive days enhanced objective sleep quality in athletes with sleep quality problems. The intervention increased sleep efficiency by lowering awake time after falling asleep.

Effects of cranial electrotherapy stimulation on improving depressive symptoms in people with stress: A randomized, double-blind controlled study

BackgroundCranial electrotherapy stimulation (CES) is a form of neurostimulation that delivers alternating microcurrent via electrodes on the head. We investigated the effectiveness of CES in reducing stress. MethodsParticipants who experienced subjective stress combined with subclinical depression or insomnia were recruited based on interviews and questionnaires. The subjects were randomly assigned to the active CES or sham groups and asked to use the device for 30 min twice a day for three weeks. Psychological rating scales, quantitative electroencephalography (QEEG), and serial salivary cortisol levels were measured before and after the intervention. ResultsSixty-two participants (58 females, mean age = 47.3 ± 8.2 years) completed the trial. After intervention, the depression scores improved significantly to a nearly normal level (Beck depression inventory-II, 31.3 ± 11.6 to 10.8 ± 7.2, p < 0.001) in the CES group, which were greater improvement compared to the sham group (p = 0.020). There were significant group-by-visit interactions in absolute delta power in the temporal area (p = 0.033), and theta (p = 0.038), beta (p = 0.048), and high beta power (p = 0.048) in the parietal area. CES led to a flattening of the cortisol slope (p = 0.011) and an increase in bedtime cortisol (p = 0.036) compared to the sham group. LimitationsBias may have been introduced during the process because device use and sample collection were self-conducted by participants at home. ConclusionsCES can alleviate depressive symptoms and stress response, showing a potential as an adjunctive therapy for stress.

An Open-Label Study of Cranial Electrotherapy Stimulation on Behavioral Regulation in a Mixed Neurodevelopmental Clinical Cohort.

Individuals with neurodevelopmental disorders often report disturbances in the autonomic nervous system (ANS)-related behavioral regulation, such as sensory sensitivity, anxiety, and emotion dysregulation. Cranial electrotherapy stimulation (CES) is a method of non-invasive neuromodulation presumed to modify behavioral regulation abilities via ANS modulation. Here we examined the feasibility and preliminary effects of a 4-week CES intervention on behavioral regulation in a mixed neurodevelopmental cohort of children, adolescents, and young adults. In this single-arm open-label study, 263 individuals aged 4-24 who were receiving clinical care were recruited. Participants received at-home CES treatment using an Alpha-Stim® AID CES device for 20 minutes per day, 5-7 days per week, for four weeks. Before and after the intervention, a parent-report assessment of sensory sensitivities, emotion dysregulation, and anxiety was administered. Adherence, side effects, and tolerance of the CES device were also evaluated at follow-up. Results showed a 75% completion rate, an average tolerance score of 68.2 (out of 100), and an average perceived satisfaction score of 58.8 (out of 100). Additionally, a comparison between pre- and post-CES treatment effects showed a significant reduction in sensory sensitivity, anxiety, and emotion dysregulation in participants following CES treatment. Results provide justification for future randomized control trials using CES in children and adolescents with behavioral dysregulation. CES may be a useful therapeutic tool for alleviating behavioral dysregulation symptoms in children and adolescents with neurodevelopmental differences.

A Systematic Review of the Interventions for Management of Pain in Patients After Spinal Cord Injury.

Chronic pain is a very common problem in patients with spinal cord injury (SCI) as it affects 80% of these patients, which negatively affects their quality of life. Despite many advantages that exist in the management of any type of pain (neuropathic, nociceptive, mixed) in these patients, there is no cure, and the analgesic effect of some treatments is inadequate. This study aims to conduct an evidence-based systematic review regarding the various interventions used for the management of pain after SCI. The PubMed, Physiotherapy Evidence Database (PEDro), and Cochrane Library databases were searched from 1969 to 2023. The risk of bias was assessed using the PEDro scoring system. A total of 57 studies met the inclusion criteria and were included in this systematic review. Among the different interventions at present, 18 studies examined the role of oral medications, 11 studies examined the role of minimally invasive methods (injection and infusion), 16 studies investigated physiotherapy and alternative treatments, and 12 studies examined the role of repetitive transcranial magnetic stimulation (rTMS), transcranial direct current stimulation (tDCS), and cranial electrotherapy stimulation (CES) in the management of pain in patients after SCI. Gabapentin and pregabalin are very effective in managing chronic neuropathic pain after SCI, and pregabalin also seems to reduce anxiety and sleep disturbances in the patients. It is noteworthy that lamotrigine, valproate, and carbamazepine do not have an analgesic effect, but mirogabalin is a novel and promising drug. Antidepressants (selective serotonin reuptake inhibitors and serotonin and noradrenaline reuptake inhibitors) did not reduce the pain of the patients, although some studies showed an efficacy of amitriptyline especially in depressed patients and tramadol should be considered short-term with caution. Also, tDCS and rTMS reduced pain. Moreover, botulinum toxin type A, lidocaine, ketamine, and intrathecal baclofen significantly reduced pain intensity, although the sample of the studies was small. Physiotherapy and alternative treatments seem to relieve pain, and transcutaneous electrical nerve stimulation had the greatest reduction of pain intensity. In conclusion, several pharmaceutical and non-pharmaceutical methods exist, which can reduce pain in patients after SCI. The type of intervention can be considered by the physician depending on the patients' preference, age, medical history, type of pain, and associated symptoms. However, more studies with greater samples and with better methodological quality should be conducted.

Alpha-Stim AID cranial electrotherapy stimulation (CES) anxiety treatment: anxiety, depression and health-related quality-of-life outcomes in primary health-care social prescribing services

PurposeThis study aims to evaluate the effect of Alpha-Stim Anxiety, Insomnia and Depression (AID) cranial electrotherapy stimulation (CES) on anxiety, depression and health-related quality of life for primary care social prescribing service patients with anxiety symptoms.Design/methodology/approachOpen-label patient cohort design with no control group. A total of 33 adult patients (average age 42 years) completed six weeks of Alpha-Stim AID use. Pre- and post-intervention assessment with participant self-report measures: Patient Health Questionnaire (PHQ-9), Generalised Anxiety Disorder (GAD-7) and European Quality of Life Five Dimension (EQ-5D-5L).FindingsReliable improvement and remission rates, respectively, were 53.39% and 33.3% for GAD-7; 46.7% and 29.5% for PHQ-9. There was a significant improvement in GAD-7 and PHQ-9 with large effect sizes. EQ-5D-5L results showed significant improvements in health-related quality of life. Perceived quality of life increased by 0.17 on the health index score, with the intervention adding 1.68 quality-adjusted life years (QALYs).Practical implicationsAlpha-Stim AID can be delivered through a primary health-care social prescribing service and most patients will use as prescribed and complete treatment course. Alpha-Stim AID CES may be an effective anxiety and depression treatment for people with anxiety symptoms. The widespread roll-out of Alpha-Stim AID in health-care systems should be considered.Originality/valueTo the best of the authors’ knowledge, this is the first study to respond to the UK’s National Institute for Health and Care (NICE) request for the collection of real-world data to understand better Alpha-Stim AID in relation to people’s treatment uptake, response rates and treatment completion rates (NICE, 2021).

The experience of using Alpha-Stim AID cranial electrotherapy stimulation (CES) for symptoms of anxiety

Background: Alpha-Stim AID is a self-administered, cranial electrotherapy stimulation (CES) device with evidence of effectiveness in treating symptoms of anxiety. In this study, Alpha-Stim AID was offered through a United Kingdom (UK) primary care social prescription service to patients with symptoms of anxiety. This study explored the experience and impact of using Alpha-Stim AID cranial electrotherapy stimulation (CES) through in-depth interviews. Methods: Out of a sample of 57 using Alpha-Stim AID, fifteen participants consented to be interviewed. The age range of the participants was 26–65 years (M = 46.6); 10 (67%) were female and 5 (33%) male. Data were analysed using thematic analysis. Results: There was support for the acceptability and useability of Alpha-Stim AID. Most participants described a positive impact in their lives and would recommend it to others. Themes that emerged offered insights into how people used the Alpha-Stim and their experiences of the effects. Conclusions: It is important to identify anxiety symptoms and offer patients choice of treatment options. The results support the use of Alpha-Stim AID as a treatment option for people with symptoms of anxiety. Access to Alpha-Stim AID should not be restricted by being able to afford to buy it. An appropriately designed randomised control trial (RCT) is required.

Cranial electrotherapy stimulation in veterans with fibromyalgia using neuroimaging as a biomarker

Cranial electrotherapy stimulation in veterans with fibromyalgia using neuroimaging as a biomarker

A preliminary study for the clinical effect of one combinational physiotherapy and its potential influence on gut microbial composition in children with Tourette syndrome.

Tourette syndrome (TS) is a chronic neuropsychiatric disorder with unknown causes and inadequate therapies. Inspired by the important roles of gut microbiota in some mental illnesses, the interactions between gut microbiota and TS via the gut-brain axis have gained more and more attention. This study aimed to characterize the gut microbial profiles in children with TS, and explore the clinical effects of one combinational physiotherapy and its potential influence on gut microbial composition. The gut microbial profiles were depicted based on the sequence data of 32 patients and 29 matched health children by 16S rDNA amplicon pyrosequencing. Thirty of thirty-two patients underwent uninterrupted two 10-day courses of combinational physiotherapy, which included a 60-minute cranial electrotherapy stimulation (CES) training followed by a 30-minute biofeedback training per session, 2 sessions a day. Our results indicated that the gut microbial composition in children with TS was different from that in healthy controls. Multiple GBM neurotransmitter modules obtained through Picrust2 functional predictive analysis were significantly increased in patients, including Histamine degradation, Dopamine degradation, and DOPAC synthesis. Moreover, this combinational physiotherapy could significantly diminish tic activity, whose positive effects were first reported in children with TS. Lastly, different gut microbial compositions and predictive metabolic pathways were also observed between patients before and after this treatment, with lower abundances of the genera (e.g., Dorea) and significant decreases of GBM neurotransmitter modules (e.g. dopamine degradation) in patients after this treatment, indicating that improved clinical symptoms might be accompanied by an improvement of intestinal microenvironment. Children with TS showed a cognizable gut microbial profile, and certain enriched bacteria with pro-inflammatory potential might induce neuroinflammatory responses. This combinational physiotherapy could significantly diminish tic activity, and the gut microbial compositions in patients after this treatment were different from those without any treatment, indicating the existence of bidirectional communication of the gut-brain axis in TS. But studies on the gut microbial characteristics in TS patients, the influences of gut microbiota on tic severity, the efficacy and safety of this treatment, and the bidirectional regulatory mechanism between brain signals and gut microbiota in TS still need to be explored.

The effect of cranial electrotherapy stimulation as adjunctive therapy on generalized anxiety disorder in elderly: an open-label, pilot study

The effect of cranial electrotherapy stimulation as adjunctive therapy on generalized anxiety disorder in elderly: an open-label, pilot study

Mechanisms of Action of Noninvasive Brain Stimulation with Weak Non-Constant Current Stimulation Approaches.

Objective: Non-constant current stimulation (NCCS) is a neuromodulatory method in which weak alternating, pulsed or random currents are delivered to the human head via scalp or earlobe electrodes. This approach is widely used in basic and translational studies. However, the underlying mechanisms of NCCS, which lead to biological and behavioral effects in the brain, remain largely unknown. In this review, we characterize NCCS techniques currently being utilized in neuroscience investigations, including transcranial alternating current stimulation (tACS), transcranial pulsed current stimulation (tPCS), transcranial random noise stimulation (tRNS), and cranial electrotherapy stimulation (CES). Method: We unsystematically searched all relevant conference papers, journal articles, chapters, and textbooks on the biological mechanisms of NCCS techniques. Results: The fundamental idea of NCCS is that these low-level currents can interact with neuronal activity, modulate neuroplasticity and entrain cortical networks, thus, modifying cognition and behavior. We elucidate the mechanisms of action for each NCCS technique. These techniques may cause microscopic effects (such as affecting ion channels and neurotransmission systems) and macroscopic effects (such as affecting brain oscillations and functional connectivity) on the brain through different mechanisms of action (such as neural entrainment and stochastic resonance). Conclusion: The appeal of NCCS is its potential to modulate neuroplasticity noninvasively, along with the ease of use and good tolerability. Promising and interesting evidence has been reported for the capacity of NCCS to affect neural circuits and the behaviors under their control. Today, the challenge is to utilize this advancement optimally. Continuing methodological advancements with NCCS approaches will enable researchers to better understand how NCCS can be utilized for the modulation of nervous system activity and subsequent behaviors, with possible applications to non-clinical and clinical practices.

Cranial Electrotherapy Stimulation (CES) for Major Depressive Disorder

Cranial electrotherapy stimulation (CES) is a noninvasive neuromodulation technique that has potential for treating several psychiatric diseases. This method consists of delivering bilateral low-intensity electrical current, via a pair of electrodes, to different anatomical targets around the head. This kind of stimulation is believed to interact with brain oscillation patterns, resulting in changes in connectivity of brain networks. CES has been observed to be a safe intervention with no serious side effects reported in randomized controlled trials. Unequivocal efficiency of CES has not been demonstrated for the treatment of major depressive disorder (MDD); however, some data suggest that CES could be an effective therapy for MDD, either as a standalone or in combination with pharmacological treatment and psychological therapy. CES devices are portable devices that do not required trained personnel to administer the treatment and therefore allow the patients to self-administer the treatment at home. [ Psychiatr Ann . 2022;52(11):461–465.]

Cranial electrotherapy stimulation alleviates depression-like behavior of post-stroke depression rats by upregulating GPX4-mediated BDNF expression

To elucidate whether cranial electrotherapy stimulation (CES) improves depression-like behavior of post-stroke depression (PSD) via regulation of glutathione peroxidase 4 (GPX4)-mediated brain-derived neurotrophic factor (BDNF) expression. Middle cerebral artery occlusion (MCAO) and chronic unpredictable mild stress (CUMS) were used to develop a rat PSD model. CES was applied, and RAS-selective lethal 3 (RSL3) was injected into the hippocampus to inhibit GPX4 in PSD rats. The depression behavior was detected by sucrose preference and forced swimming tests. The structure and morphology of the hippocampus were observed and analyzed by histopathological hematoxylin-eosin (HE) staining. The mRNA and protein expressions of GPX4 and BDNF in the hippocampus were detected by qRT-PCR, western blot and immunohistochemical analysis.The degeneration and necrosis of hippocampal neurons, the depression-like behavior were severer and the expression of BDNF in the hippocampus were decreased in PSD rats than those in MCAO and control groups. CES promoted the hippocampal neuron repair, alleviated the depression-like behavior and increased the expression of BDNF in PSD rats. The inhibition of GPX4 by RSL3 exacerbated the depression-like behavior and decreased the expression of BDNF in PSD rats. In addition, we found that RSL3 disrupted the positive effects of CES on the PSD rats. Conclusion: CES improves depression-like behavior of PSD rats through upregulation of GPX4-mediated BDNF expression in the hippocampus.

Cranial electrotherapy stimulation in the treatment of posttraumatic stress disorder: A feasibility, safety, and preliminary efficacy study

BackgroundNeuromodulation of brain circuits important for affect, behavior, and cognition may decrease the symptomatology and functional impairment of military veterans suffering from posttraumatic stress disorder (PTSD). Cranial electrotherapy stimulation (CES) techniques, such as Alpha-Stim®, have demonstrated preliminary benefit for symptoms that commonly co-occur with PTSD, such as pain, anxiety, depression, and insomnia. However, CES has not yet been specifically tested as a treatment for PTSD. The objective of this open-label pilot study was to examine feasibility, safety, and preliminary efficacy of Alpha-Stim® for treatment of PTSD. MethodsOpen-label Alpha-Stim® was administered to nine veterans who were diagnosed with PTSD via structured interview (Clinician-Administered PTSD Scale for DSM-5 [CAPS-5]) and were taking at least one psychotropic medication. Treatment consisted of 20 CES sessions administered at home over 40 days. Effects on PTSD symptoms, functioning, depression symptoms, pain, anxiety symptoms, and insomnia were assessed at baseline and every week of treatment for four weeks. Effects on PTSD symptoms, depression symptoms, and pain were assessed one month and three months post-treatment. ResultsSeven patients (78%) successfully completed treatment. There were no adverse events. Following four weeks of Alpha-Stim® treatment, PTSD symptoms decreased by 38%, depression symptoms decreased by 52%, insomnia decreased by 34%, and pain decreased by 11%. Significant improvements in PTSD and depression, but not pain, persisted at one-month and three-months posttreatment. Presumptive loss of diagnosis rates (i.e., PTSD Checklist for DSM-5 total score below 33) immediately following treatment and one and three months later were 43%, 33%, and 29%, respectively. ConclusionsAlpha-Stim® showed an excellent safety profile with no adverse effects. The results suggest preliminary efficacy for improving PTSD symptoms as well as concomitant depression symptoms, insomnia, and pain. Limitations of this pilot study include the open-label, uncontrolled design and small sample size. These results support additional larger, randomized controlled trials of Alpha-Stim® for veterans with PTSD.

Comparison of the effects of cranial electrotherapy stimulation and midazolam as preoperative treatment in geriatric patients: A CONSORT-compliant randomized controlled trial.

Background:Although midazolam is widely administered as an anxiolytic premedication, it may cause over-sedation and hypoxia in geriatric patients. Cranial electrotherapy stimulation (CES) is a nonpharmacological device with anxiolytic effect. This study compared the effects of CES and midazolam as a preoperative treatment in geriatric patients.Methods:Eighty patients, under the age of 65 to 79 years, undergoing general anesthesia were randomly assigned into midazolam premedication group (M group, n = 40) or CES pretreatment group (CES group, n = 40). The patients in the M group were intramuscularly injected with midazolam (0.07 mg/kg) 30 minutes before receiving general anesthesia. The patients in the CES group received 20 minutes of CES pretreatment on the day before and on the morning of the surgery.Results:In the preoperative holding area, the anxiety score (P = .02) and the sedation score (P < .001) were significantly lower in the CES group compared with those in the M group. The oxygen saturations at the preoperative holding area and the operating room were significantly higher in the CES group than those in the M group (P < .001).Conclusion:CES pretreatment relieved preoperative anxiety with less risk of over-sedation and respiratory depression than midazolam premedication in geriatric patients.

Efficiency of appliance of cranial electrotherapy stimulation and fabomotizole medication as part of combination therapy of patients with lichen ruber planus

BACKGROUND: Taking into consideration importance of a stress factor in the pathogenesis of lichen ruber planus, it seems reasonable and promising to include safe and effective methods for its correction in the therapy of such patients.&#x0D; AIMS: To evaluate efficiency of the combination therapy in patients with lichen ruber planus with inclusion of cranial electrotherapy stimulation and fabomotizole medication.&#x0D; MATERIALS AND METHODS: The object of the study included 65 patients (42 women ― 64.6% and 23 men ― 35.4% at the ages from 18 to 75 (43.815.3 years) with a common typical form of lichen ruber planus. Duration of the disease ranged from 1 to 42 months (13.311.6 months). Two groups were formed by the method of adaptive randomization. In the main group (n=33), patients received chloroquine of 250 mg orally twice a day, topical glucocorticosteroids and additionally cranial electrotherapy stimulation. In the comparison group (n=32), the similar therapy was carried out, but instead of cranial electrotherapy stimulation, fabomotizole of 10 mg was prescribed orally 3 times a day after meals. The course of hospital treatment in both groups was 21 days, the follow-up was 12 weeks. Results of the therapy were assessed on the 7; 14 and 21st days. The examination algorithm included: assessment of clinical manifestations taking into account the Index Lichen Planus; the impact of pruritus on the daily life of patients with the help of the generally accepted Behavioral rating scores questionnaire; study of the psychoemotional state of patients using the Dermatology Life Quality Index, Hamilton Anxiety Scale and Hamilton Depression Rating Scale.&#x0D; RESULTS: Before prescription of the therapy in both groups, there were no statistically significant differences (p 0.001) in the studied indices, scales, and questionnaire. After the combination therapy in association with cranial electrotherapy stimulation in patients of the main group, starting from the 7th day of the therapy, significantly more favorable results were achieved in terms of the studied parameters (Index Lichen Planus, Dermatology Life Quality Index, Hamilton Anxiety Scale and Hamilton Depression Rating Scale). As for the effect of pruritus on the daily activities of patients (Behavioral rating scores questionnaire), in both groups there was its equally statistically significant (p 0.001) decrease. Patients of the main group and the comparison group tolerated the treatment well, there were no side effects.&#x0D; CONCLUSIONS: In the main group, using cranial electrotherapy stimulation, normalization of indicators reflecting the activity of the skin pathological process, psychoemotional state and dermatology life quality was statistically significant and took place within a shorter period of time.

A randomised controlled trial investigating the clinical and cost-effectiveness of Alpha-Stim AID cranial electrotherapy stimulation (CES) in patients seeking treatment for moderate severity depression in primary care (Alpha-Stim-D Trial)

BackgroundMajor depression is the second leading cause of years lost to disability worldwide and is a leading contributor to suicide. However, first-line antidepressants are only fully effective for 33%, and only 40% of those offered psychological treatment attend for two sessions or more. Views gained from patients and primary care professionals are that greater treatment uptake might be achieved if people with depression could be offered alternative and more accessible treatment options. Although there is evidence that the Alpha-Stim Anxiety Insomnia and Depression (AID) device is safe and effective for anxiety and depression symptoms in people with anxiety disorders, there is much less evidence of efficacy in major depression without anxiety. This study investigates the effectiveness of the Alpha-Stim AID device, a cranial electrotherapy stimulation (CES) treatment that people can safely use independently at home. The device provides CES which has been shown to increase alpha oscillatory brain activity, associated with relaxation.MethodsThe aim of this study is to investigate the clinical and cost-effectiveness of Alpha-Stim AID in treatment-seeking patients (aged 16 years upwards) with moderate to moderately severe depressive symptoms in primary care. The study is a multi-centre parallel-group, double-blind, non-commercial, randomised controlled superiority trial. The primary objective of the study is to examine the clinical efficacy of active daily use of 8 weeks of Alpha-Stim AID versus sham Alpha-Stim AID on depression symptoms at 16 weeks (8 weeks after the end of treatment) in people with moderate severity depression. The primary outcome is the 17-item Hamilton Depression Rating Scale at 16 weeks. All trial and treatment procedures are carried out remotely using videoconferencing, telephone and postal delivery considering the COVID-19 pandemic restrictions.DiscussionThis study is investigating whether participants using the Alpha-Stim AID device display a reduction in depressive symptoms that can be maintained over 8 weeks post-treatment. The findings will help to determine whether Alpha-Stim AID should be recommended, including being made available in the NHS for patients with depressive symptoms.Trial registrationISRTCN ISRCTN11853110. Registered on 14 August 2020

Cranial Electrotherapy Stimulation to Improve the Physiology and Psychology Response, Response-Ability, and Sleep Efficiency in Athletes with Poor Sleep Quality.

Athletes often have poor sleep quality before a competition. Sleep quality can stabilize mood and improve sports performance. The randomized controlled study explored the effects of cranial electrotherapy stimulation (CES) on the physiology, psychology, response-ability, and sleep quality of athletes who had poor sleep quality before a competition. Athletes who had poor sleep quality (Pittsburgh Sleep Quality Scale score > 5) and had a competition in less than 2 months were recruited. The athletes were grouped into the CES group, which received a 2-week CES treatment (n = 20, age = 21.55 ± 2.26 years), and a placebo group (n = 20, age = 21.05 ± 1.46 years), which received a 2-week sham CES treatment. We performed biochemical analysis, a simple reaction time test, choice reaction time tests, the Profile of Mood States, heart rate variability (HRV), and an Actigraphy activity recorder to measure outcomes before and after the interventions. Our results revealed no significant differences in blood urea nitrogen, creatine phosphate, testosterone, cortisol, and saliva pH between and within groups (p > 0.05). Significant decreases in negative mood states (i.e., anger, tension, and depression) and choice reaction time in the CES group were noted (p < 0.05), moreover, the anger, tension, and depression mood decreased from 0.36 ± 0.45 (95% CI = 0.16–0.55), 1.62 ± 0.97 (95% CI = 1.19–2.04), and 1.67 ± 1.06 (95% CI = 1.20–2.13) to 0.11 ± 0.20 (95% CI = 0.02–0.19, p = 0.03), 1.12 ± 0.74 (95% CI = 0.79–1.44, p = 0.04), and 0.81 ± 0.75 (95% CI = 0.48–1.13, p = 0.001), respectively. Additionally, choice reaction time was decreased from 420.85 ± 41.22 ms (95% CI = 402.78–438.91) to 399.90 ± 36.71 ms (95% CI = 383.81–415.98, p = 0.04) and was also noted in the CES group. For HRV, and Actigraphy activity for sleep measure, the low-frequency (LF)/high-frequency (HF) ratios changed from 1.80 ± 1.39 (95% CI = 1.19–2.40) to 1.21 ± 0.73 (95% CI = 0.89–1.53, p = 0.10), and sleep efficiency decreased from 87.94 ± 6.76% (95% CI = 84.97–90.90) to 81.75 ± 9.62% (95% CI = 77.53–85.96, p = 0.02) in the CES group. The change in LF/HF after the trial were found between CES and placebo groups (p < 0.05). Yet, the decrease in sleep efficiency in the placebo group were noted (p < 0.05). However, we found that the regression line for sleep efficiency was decreased less during the study while using CES. The CES intervention could reduce negative emotions, improve choice reaction times, enhance the parasympathetic and sympathetic nerve activity imbalances, and slow sleep efficiency deterioration. Regardless, small effect sizes of the application of CES on psychology response, response-ability, and sleep efficiency were concluded in athletes with poor sleep quality before a competition.