Neurostimulator Research Articles

Upper Airway Stimulation in Female Patients: Safety and Efficacy of a Novel Lateral Approach.

To describe a novel lateral approach for hypoglossal nerve stimulator (HNS) implantation in women and provide evidence for its safety and efficacy. Retrospective case series. Single academic medical center. We identified patients implanted with HNS by a single surgeon from January 2017 to December 2021. Patient characteristics, postoperative complications, surgical duration, response to therapy, and need for revision surgery were recorded. One hundred four patients were included, including 93 males and 11 females. The lateral approach for HNS implantation involves placing the chest incision for the implantable pulse generator and respiratory sensor lead vertically in the anterior axillary line instead of horizontally in the infraclavicular area. No changes are made to the stimulator lead placement. All female patients were implanted using a lateral approach and all male patients were implanted via the standard anterior approach. Half of the patients were implanted via a 2-incision technique. The median surgical time duration was equivalent in male and female patients (119 [interquartile range (IQR): 105-138] vs 126 [IQR: 115-141], respectively). Revision was required in 2 (18%) females versus 6 (6%) males (p = .17). There were equivalent rates of therapy response as well as postoperative complications. A more cosmetic lateral approach is feasible for HNS in female patients and has a similar rate of adverse events and therapy responsiveness. Additional considerations in female patients include the ability to tolerate mammography as well as HNS implantation in the setting of existing breast implants.

A single-center, open-label trial on convenience and complications of rechargeable implantable pulse generators for spinal cord stimulation: The Recharge Pain Trial

Rechargeable implantable pulse generators (r-IPGs) have been available for spinal cord stimulation (SCS) claiming to offer a longer service life but demanding continuous monitoring and regular recharging by the patients. The aim of the study (DRKS00021281; Apr 7th, 2020) was to assess the convenience, safety, and acceptance of r-IPGs and their effect on patient lives under long-term therapy. Standardized questionnaires were sent to all chronic pain patients with a r-IPG at the time of trial. Primary endpoint was the overall convenience of the charging process on an ordinal scale from “very hard” (1 point) to “very easy” (5 points). Secondary endpoints were charge burden (min/week), rates of user confidence and complications (failed recharges, interruptions of therapy). Endpoints were analyzed for several subgroups. Data sets n = 40 (42% return rate) were eligible for analysis. Patient age was 57.2 ± 12.6 (mean ± standard deviation) years with the r-IPG being implanted for 52.1 ± 32.6 months. The overall convenience of recharging was evaluated as “easy” (4 points). The charge burden was 112.7 ± 139 min/week. 92% of the patients felt confident recharging the neurostimulator. 37.5% of patients reported failed recharges. 28.9% of patients experienced unintended interruptions of stimulation. Subgroup analysis only showed a significant impact on overall convenience for different models of stimulators (p < 0.05). Overall, SCS patients feel confident handling a r-IPG at high rates of convenience and acceptable effort despite high rates of usage-related complications. Further technical improvements for r-IPGs are needed.

Opioid-Related Side Effects and Complications After Intrathecal Morphine Trial or Pump Implantation

Objective: A few cases of post-surgical spine syndrome (PSSS) are resistant to standard treatment. Intrathecal morphine (ITM) therapy can be used to achieve improved pain control with fewer side effects compared to systemic analgesics alone. ITM-associated complications may be associated with the intrathecal catheter, implanted pump, device management, and the drugs themselves.Methods: Twenty-six patients with PSSS were retrospectively evaluated. All patients had visual analog scale (VAS) scores of 7 or higher, which continued for more than 6 months, and all received a single dose of the ITM trial. If the VAS score was reduced by 50%, and there were no side effects from the trial, ITM pump (ITMP) implantation was performed for continuous morphine injection to control pain. Of the 26 patients, 19 underwent only the ITM trial, and 7 in whom the VAS decreased by more than 50% after the trial further underwent ITMP implantation. Patients who underwent only the trial were observed for an average of 5.4 days (range: 3–14 days), and those who underwent ITMP implantation were observed for an average of 55.9 months (range: 15–123 months). The occurrence of side effects following ITM injection and complications related to the ITM trial or ITMP implantation were analyzed. Results: The most common complications were drug side effects (n=11), followed by procedural (n=1) and equipment (n=1) side effects. The most common symptoms were urinary difficulty (n=8) and pruritus (n=3). Serious complications included a large lumbosacral subdural hematoma, intradural fibrotic tissues at the lumbar puncture site, and urinary retention (n=1). A case of mid-catheter occlusion caused by precipitated morphine crystals and skin infection on an implantable pulse generator was also reported (n=1). In another case, skin necrosis was observed in the surgical area (n=1). Conclusion: The most common drug-related side effect is urination difficulty, and patients generally recover within a few days after the ITM trial. Complications, such as procedure-related subdural bleeding or IT catheter blockage, may also occur. A better understanding of IT drugs, equipment, and meticulous procedural techniques, can allow a reduction of complications.

Parasympathetic control of gastrointestinal motility and cross-branch actions of parasympathetic neuromodulation.

Parasympathetic control of gastrointestinal motility and cross-branch actions of parasympathetic neuromodulation.

A Fully Implantable and Programmable Epidural Spinal Cord Stimulation System for Rats with Spinal Cord Injury.

Epidural spinal cord stimulation (ESCS) is a potential treatment for the recovery of the motor function in spinal cord injury (SCI) patients. Since the mechanism of ESCS remains unclear, it is necessary to study the neurophysiological principles in animal experiments and standardize the clinical treatment. In this paper, an ESCS system is proposed for animal experimental study. The proposed system provides a fully implantable and programmable stimulating system for complete SCI rat model, along with a wireless charging power solution. The system is composed of an implantable pulse generator (IPG), a stimulating electrode, an external charging module and an Android application (APP) via a smartphone. The IPG has an area of 25×25 mm2 and can output 8 channels of stimulating currents. Stimulating parameters, including amplitude, frequency, pulse width and sequence, can be programmed through the APP. The IPG was encapsulated with a zirconia ceramic shell and two-month implantable experiments were carried out in 5 rats with SCI. The main focus of the animal experiment was to show that the ESCS system could work stably in SCI rats. The IPG implanted in vivo can be charged through the external charging module in vitro without anesthetizing the rats. The stimulating electrode was implanted according to the distribution of ESCS motor function regions of rats and fixed on the vertebrae. The lower limb muscles of SCI rats can be activated effectively. The two-month SCI rats needed greater stimulating current intensity than the one-month SCI rats The results indicated that the stimulating system provides an effective and simplified tool for studying the ESCS application in motor function recovery for untethered animals.

Early Experience With a Novel Miniaturized Spinal Cord Stimulation System for the Management of Chronic Intractable Pain of the Back and Legs

IntroductionA novel, spinal cord stimulation (SCS) system with a battery-free miniaturized implantable pulse generator (IPG) was used in this feasibility study. The system uses an external power source that communicates bidirectionally with the IPG (< 1.5 cm3). Human factors, subject comfort, and effects on low back and leg pain were evaluated in this first-in-human study. Materials and MethodsA prospective, multicenter, open-label clinical trial was initiated to evaluate the safety and performance of a novel miniaturized stimulator in the treatment of chronic, intractable leg and low-back pain. Eligible subjects were recruited for the study and gave consent. Subjects who passed the screening/trial phase (defined as ≥ 50% decrease in pain) continued to the long-term implant phase and were followed up at predefined time points after device activation. Interim clinical and usability outcomes were captured and reported at 90 days. ResultsResults of 22 subjects who chose a novel pulsed stimulation pattern therapy using the battery-free IPG (< 1.5 cm3) are described here. At 90-days follow-up, the average pain reduction was 79% in the leg (n = 22; p < 0.0001) and 76% in the low back (n = 21; p < 0.0001) compared with baseline. Responder rates (≥ 50% pain relief) at 90 days were 86% in leg pain (19/22) and 81% in low-back pain (17/21). Subjects rated the level of comfort of the external wearable power source to be 0.41 ± 0.73 at 90 days on an 11-point rating scale (0 = very comfortable, 10 = very uncomfortable). DiscussionThese interim results from the ongoing study indicate the favorable efficacy and usability of a novel, externally powered, battery-free SCS IPG (< 1.5 cm3) for leg and low-back pain. Study subjects wore the external power source continuously and found it comfortable, and the system provided significant pain relief. These preliminary findings warrant further investigation. Clinical Trial RegistrationThe Clinicaltrials.gov registration number for the study is ACTRN12618001862235.

Patient-Reported Satisfaction with Using a Rechargeable 10 kHz Spinal Cord Stimulation Device

Chronic pain is a common clinical condition and is frequently treated with a variety of medications, but pharmacotherapy is oftentimes not the optimal long-term treatment option. Safe and effective long-term pain relief for trunk and limb pain is available using high-frequency spinal cord stimulation at 10 kHz (10 kHz SCS), which is delivered using a rechargeable implantable pulse generator (IPG). Although rechargeable devices have been shown to reduce patient risk and overall cost by eliminating the need for periodic surgeries to replace depleted non-rechargeable IPGs, there is little published evidence that rechargeable technology is practical and convenient for patients, especially in the context of 10 kHz SCS. This analysis of real-world patients implanted with 10 kHz SCS devices was undertaken using patient data from an industry-maintained database to investigate whether there was a substantial burden associated with rechargeable SCS and the degree of patient satisfaction or dissatisfaction with 10 kHz SCS. This study included 10,391 men and women who were implanted with 10 kHz SCS devices to treat chronic pain of the trunk and/or limbs. They received stimulation for a median of 361 days (180-1550 days), and 65.48% had previous spine surgery. In this patient sample, most patients were satisfied with the efficacy of 10 kHz SCS, including 77% who would repeat the procedure and 71% who would recommend it to other patients with similar pain. In regards to IPG recharging, 70% were satisfied or very satisfied and 19% were neutral, and a majority of patients recharged their device daily for 30 to 60 minutes. These results indicate most patients do not find IPG recharging inconvenient or burdensome. In addition, IPG recharging is not a barrier to the majority of patients benefitting from 10 kHz SCS for long-term pain relief.

Clinical Practice Guidelines for the Therapeutic Use of Repetitive Transcranial Magnetic Stimulation in Neuropsychiatric Disorders.

Clinical Practice Guidelines for the Therapeutic Use of Repetitive Transcranial Magnetic Stimulation in Neuropsychiatric Disorders.

Cerebrospinal Fluid Leakage to the Chest Subcutaneous Pocket Due to Aggressive Brain Edema around the Leads for Deep Brain Stimulation: A Case Report and Literature Review

Cerebral edema around the lead has been reported as a complication of deep brain stimulation; however, the causes remain unknown. Herein, we present a rare case of sudden cerebral edema around the lead occurring after deep brain stimulation. This was accompanied by cerebrospinal fluid (CSF) leakage into the subcutaneous thoracic pocket around the implantable pulse generator in a 53-year-old man with Parkinson's disease. No such case has been reported thus far. Lumbar drainage was performed to improve CSF leakage. The cerebral edema initially responded to steroids, but then it stopped responding to treatment. The edema appeared alternately on the left and right sides, and cyst formation was noted around the left lead. There are some reports of cyst formation around the lead; however, in our case, images were used to monitor the edema and cyst from their appearance to their disappearance. Our data suggest that cyst formation and cerebral edema are related.

Sacral neuromodulation for overactive bladder using the InterStim and BetterStim systems

This study aimed to evaluate differences in the clinical outcomes of different sacral neuromodulation systems (InterStim and BetterStim) used in the treatment of overactive bladder. Data from a previously established database of sacral neuromodulation in China (the InterStim system) and a 2020 clinical trial of the BetterStim system were screened. Patients with overactive bladder undergoing stage II implanted pulse generator implantation were selected for analysis and divided into InterStim and BetterStim system groups. Voiding diaries and subjective scores obtained preoperatively, after stage I tined-lead implantation (experience period), and after stage II implanted pulse generator implantation were compared between the two groups. This study included 113 patients with overactive bladder (43, InterStim system group; 70, BetterStim system group). Voiding diaries and subjective scores significantly improved in both the InterStim and BetterStim system groups over the treatment period. Specifically, the urination frequency (all P < 0.001), average voiding volume (all P < 0.001), and average urinary leakage (InterStim, P < 0.05; BetterStim, P < 0.01) in both groups significantly improved at different periods during treatment. At the same time, the urgency perception scale (P < 0.001) and OAB-related quality of life score (InterStim, P < 0.05; BetterStim, P < 0.01) also significantly improved. There was no significant difference in urination frequency at baseline between the two groups (P = 0.169). Urination frequency was significantly higher in the BetterStim system group than in the InterStim group during the experience period and at follow-up (P = 0.031, P = 0.006). There was no significant difference in the number of urinary leakages between the different systems at baseline (P = 0.662), although this was higher in the InterStim system group during the experience period (P = 0.016), and the difference disappeared at the last follow-up (P = 0.565). There were significant differences in baseline urgency perception scale (P = 0.001) and OAB-related quality of life score (P < 0.001) between the two groups; however, these differences were not maintained at follow-up (P = 0.81, P = 0.479). Both sacral neuromodulation systems are safe and effective in treating overactive bladder. The InterStim system may be more beneficial for patients with dry overactive bladder. Satisfactory outcomes may be achieved with the BetterStim system in patients with wet overactive bladder. However, further studies are required to confirm this finding.

Cosmetic considerations for placement of deep brain stimulation pulse generator: the submammary subfascial approach.

Deep brain stimulation (DBS) is an effective treatment for a number of debilitating neurological diseases. However, the placement of an implantable pulse generator (IPG) can lead to significant cosmetic concerns for some patients. We present a subfascial technique of DBS IPG implantation under the breast using a more concealed scar location. The technique is illustrated in a female patient who favored a more aesthetic placement of the DBS to treat essential tremor. Relevant literature of this approach from both breast augmentation and cardiac pacemaker implantation was reviewed. An excellent cosmetic outcome was demonstrated, and reviewing the literature, implanting under the pectoralis major fascia has the potential benefit of reducing complication rates associated with silicone implant placement in the plastic surgery literature when compared to other planes. The subfascial implantation of IPG was described. This plane, which is used routinely in breast augmentation, has the potential to decrease complication rates compared to placement in the subglandular plane. An inframammary incision provides patients with concerns about the scar and stigmata associated with an infraclavicular location of DBS generator a better cosmetic outcome.

Predictive nomogram for deep brain stimulation-related infections.

Infection is one of the important and frequent complications following implantable pulse generator and deep brain stimulation (DBS) electrode insertion. The goal of this study was to retrospectively evaluate and identify potential risk factors for DBS infections. From January 2015 to January 2021 in Qingdao municipal hospital (training cohort) and The First Affiliated Hospital of the University of Science and Technology of China (validation cohort), the authors enrolled patients with Parkinson disease who had undergone primary DBS placement or implantable pulse generator replacement. The cases were divided into infection or no-infection groups according to the 6-month follow-up. The authors used the logistic regression models to determine the association between the variables and DBS infection. Depending on the results of logistic regression, the authors established a nomogram. The calibration curves, receiver operating characteristic curve analysis, and decision curves were used to evaluate the reliability of the nomogram. There were 191 cases enrolled in the no-infection group and 20 cases in the infection group in the training cohort. The univariate logistic regression showed that BMI, blood glucose, and albumin were all significant predictors of infection after DBS surgery (OR 0.832 [p = 0.009], OR 1.735 [p < 0.001], and OR 0.823 [p = 0.001], respectively). In the crude, adjust I, and adjust II models, the three variables stated above were all considered to be significant predictors of infection after DBS surgery. The calibration curves in both training and validation cohorts showed that the predicted outcome fitted well to the observed outcome (p > 0.05). The decision curves showed that the nomogram had more benefits than the "All or None" scheme. The areas under the curve were 0.93 and 0.83 in the training and validation cohorts, respectively. The nomogram included BMI, blood glucose, and albumin, which were significant predictors of infection in patients with DBS surgery. The nomogram was reliable for clinical application.

Saving the Exposed Deep Brain Stimulation Implant: A Comprehensive Review of Implant Extrusion and Reconstructive Options

Deep brain stimulation (DBS) for the treatment of Parkinson disease is susceptible to complications, such as hardware extrusion, most commonly at the scalp and chest. The authors describe their experience with the management of hardware extrusion and reconstruction with one of the largest single-institution experience and suggest an evidence-based treatment algorithm for the management of such cases. A retrospective review of hospital records was performed to identify patients who underwent DBS-related surgery and reconstruction from January 2015 to April 2020. Management of these patients involved culture-directed antibiotics, local wound debridement, various forms of reconstruction, and hardware removal when indicated. Ninety-four patients with 131 DBS-related procedures were included. Twelve patients (12.8%) had hardware extrusion, of which 6 occurred primarily at the scalp and 6 occurred primarily at the chest. Primary closure of scalp wounds (odds ratio, 0.05 [0.004-0.71], P = 0.035) was negatively associated with treatment success. The type of reconstruction of chest wounds did not affect its success ( P = 0.58); however, none of them involved a new surgical bed, such as contralateral or hypochondrial placement. Hardware extrusion is a significant complication of DBS-related surgery. Management of extrusion at the scalp should involve the use of tension-free, well-vascularized locoregional flaps as opposed to primary closure. Implantable pulse generator extrusions at the chest can be managed with both primary closure and repositioning in a new surgical bed. Extruded DBS implants may be salvaged with appropriate reconstructive considerations, and the authors suggest an evidence-based treatment algorithm.

An antibiotic envelope to reduce infections in deep brain stimulation surgery

The therapeutic benefits of Deep Brain Stimulation (DBS) surgery in patients with movement disorderssuch as Parkinson’s Diseaseare life-altering. Surgical site infections (SSI), however, can result in increasedhospitalisations, prolonged antibiotics and neurological sequelae. We performed aretrospective review to evaluate the effectiveness of an antibiotic envelope to reduce SSI in DBS surgeries.This study includedall DBS surgeries performed between August 2020 to May 2022 using a single-use, multifilament, antibiotic-coated mesh envelope wrapped around the DBS implantable pulse generator (IPG)(TYRX™ Absorbable Antibacterial Envelope,Medtronic Fridley, MN, USA). Standardised infection-prevention measures were applied and various patient-specific and surgery-specific factors were analysed.44 patients were analysed with 26 (59.1 %) primary implantations and 18 (40.9 %) revision surgeries.The median age was 65 years old with an average follow-up of 13.5 months (range 3–24 months). The mean Body Mass Indexwas 24.0 (range 16.7–35.6). 8 (18.2 %) patients had underlying diabetes mellitus. There were only 2 (4.5 %) SSIs reported with neither involvingthe subcutaneous IPG and antibiotic envelope. 1 superficial-incisional SSI (2.3 %) was from a prior retro-auricular abscess around a lead-wirerequiring antibiotics and subcutaneous implanttransposition. The other was a deep-incisional SSI (2.3 %) from repetitive trauma causingdelayed scalp wound dehiscence and lead-wire extrusion, requiring antibiotics and wound revision. Both subjects were discharged well with no implants removed. Theantibioticenvelope therefore appears to be a safe and well-tolerated adjunct that may reduce SSIs in DBS surgery. Further prospective work withlarger sample sizes in a multi-institution setting is required.

A Survey on the Choice of Spinal Cord Stimulation Parameters and Implantable Pulse Generators and on Reasons for Explantation.

Spinal Cord Stimulation (SCS) is a vital treatment for chronic intractable pain. In the last few years, the field has undergone dramatic changes in new waveform and frequency introduction as well as device miniaturization. It is important to understand contemporary practice patterns regarding these parameters. We surveyed the active membership of Spine Intervention Society (SIS), and American Society of Regional Anesthesia (ASRA) on their practices regarding various aspects of Spinal Cord Stimulation therapy. Here we report on SCS waveform usage, battery types, and causes of explant in this cohort of providers. There was similar degree of usage of tonic, burst, and 10 kHz usage at 71.5%, 74.1% and 61.7% respectively. Dorsal root ganglion stimulation was used by 32.6% and other modes of stimulation by 13.5%. Rechargeable systems were often or always used by 67.2% whereas 10% never used a rechargeable system. Most common cause of explant was loss of effectiveness, reported by 53.7%. There has been significant adoption of new waveforms in daily practice of spinal cord stimulation therapy and there is robust mixed usage of new waveforms and frequencies. Rechargeable systems are the most commonly used but primary cell is also used in significant numbers. Loss of efficacy remains the most common cause of explant for the majority of practitioners. This survey establishes practice patterns of SCS usage regarding these important variables against which future changes can be gauged.

Recharge PSYCH: A Study on Rechargeable Implantable Pulse Generators in Deep Brain Stimulation for Psychiatric Disorders

Rechargeable implantable pulse generators (r-IPGs) for deep brain stimulation (DBS) promise longer battery life and fewer replacement surgeries versus non-rechargeable systems. Long-term data on the effects of recharging in patients who received DBS for psychiatric indications is limited. The Recharge PSYCH trial is the first study that included DBS patients with psychiatric disorders treated with different r-IPG models. Standardized questionnaires were sent to all psychiatric DBS patients with an r-IPG implanted at the time of the study. The primary endpoint was convenience of recharging. Secondary endpoints were rate of user confidence and rate of usage-related complications, as well as charge burden (defined as minutes per week needed to recharge). Data sets of n= 21 patients were eligible for data analysis. At the time of the survey patients were implanted with the r-IPG for a mean 31.8±22.4months. Prior to being implanted with an r-IPG, patients had undergone a median of 3 IPG replacements. The overall convenience of the charging process was rated as "easy" with a median of 8.0 out of 10.0 points. 33.3% of patients experienced situations in which the device could not be successfully recharged. In 38.1% of patients, therapy with the r-IPG was interrupted unintentionally. The average charge burden was 286±22.4minutes per week. Patients with psychiatric disorders rated the recharging process as "easy", but with a significantly higher charge burden and usage-related complication rates compared to published data on movement disorder DBS patients.

Synchronized Diaphragmatic Stimulation for Heart Failure With a Reduced Left Ventricular Ejection Fraction Using the VisONE System: A First-in-Patient Study With Extended Population

BackgroundSynchronized diaphragmatic stimulation (SDS) produces localized contractions of the diaphragm gated to the cardiac cycle to transiently modulate intrathoracic pressures, thereby impacting cardiac function for heart failure patients with reduced ejection fraction (HFrEF). This study prospectively evaluated the safety and 1-year effectiveness of SDS in an expanded first-in-patient cohort using multiple implant methods. MethodsSymptomatic patients with HFrEF despite guideline-directed therapy were enrolled. Patients were evaluated at 3, 6 and 12 months for adverse events, quality of life (SF-36 QOL), echocardiography and 6-minute hall walk distance. The SDS system consists of 2 bipolar, active-fixation leads, and an implantable pulse generator. ResultsNineteen men were enrolled (age 63 [57, 67] years, New York Heart Association class II [53%]/III [47%], N-terminal pro B-type natriuretic peptide 1779 [886, 2309] pg/mL, left ventricular ejection fraction 27 [23, 33] %). Three implant techniques (abdominal laparoscopy: sensing and stimulating leads on the inferior diaphragm (n = 15); subxiphoid access for an epicardial sensing lead and abdominal laparoscopy for stimulation on the inferior diaphragm (n = 2); thoracoscopy to place an epicardial sensing lead and a stimulating lead on the superior diaphragm (n = 2)) were employed with 100% success. Patients were unaware of diaphragmatic stimulation. From discharge to 12 months, 6-minute hall walk distance increased (315 [296, 332]m to 340 [319, 384]m; p = 0.002), left ventricular end-systolic volume decreased (135 [114, 140]mL to 99 [90, 105]mL; p = 0.04), and SF-36 QOL improved (physical scale 0 [0, 0] to 25 [0, 50], p = 0.004; emotional scale 0 [0, 33] to 67 [33, 67], p = 0.001). N-terminal pro B-type natriuretic peptide was lower (1784 [944, 2659]pg/mL vs. 962 [671, 1960]pg/mL; p = ns) and left ventricular ejection fraction increased (28 [23, 38]% vs. 35 [31, 40]%; p = ns) although neither reached statistical significance. There were no procedure- or SDS-related adverse events. ConclusionsThese data demonstrate that SDS can be delivered using alternative implantation methods without raising safety concerns and suggest improved outcomes over 1 ​year of follow-up. Adequately powered randomized trials are now needed to confirm these findings.

Constant current or constant voltage deep brain stimulation: short answers to a long story.

Recently, the feature of generating constant current output has been added to the implantable pulse generators (IPGs). The efficacy of the conventionally used constant voltage (CV) stimulation has been proved in different movement and psychiatric disorders. In this systematic review, we aimed to discuss the effect of constant current (CC) and constant voltage stimulation on patients with Parkinson's disease (PD) who had subthalamic nucleus deep brain stimulation implantation; we also compared these methods of stimulation with each other. Using the words "Deep brain stimulation", "constant current" and "constant voltage", we developed a broad search strategy and a systematic search was conducted in PubMed, Scopus, Web of Science and Cochrane electronic bibliographic databases. Studies on the Parkinson's disease patients with subthalamic deep brain stimulation, which mentioned constant current or/and constant voltage setting stimulation were included. After screening of 284 articles, 10 reports were found eligible for this study. The score of unified Parkinson's disease rating scale part 3 was improved compared to the baseline, whether the stimulation was CV at baseline or CC. No significant change in non-motor outcomes was found. Although CC stimulation has shown a significant improvement in both motor and non-motor symptoms of PD, switching from CV to CC did not result in a significant change in the score of these items based on UPDRS. To sum up, implantation of constant current devices is safe and significantly improves motor function; it also maintains an acceptable safety profile in patients with PD.

Replacement Adaptor 09106 for patients with a dynamic graciloplasty or patients with sacral neuromodulation and abdominal implantable pulse generators: a retrospective, single centre, Stage 2a/2b development IDEAL case series.

Due to the introduction of a new implantable pulse generator (IPG), the Interstim II, patients with either a dynamic graciloplasty or an abdominally placed IPG for sacral neuromodulation could not undergo surgery to replace their IPG in the case of end of battery life. For these patients, the Medtronic Replacement Adaptor 09106 was created. This retrospective case series aims to study safety and feasibility of the Medtronic Replacement Adaptor 09106 in patients with abdominally placed IPGs. Seventeen patients (11 women, six men) received a replacement adaptor with a follow-up of 6months. Outcome measures consisted of a bowel habit diary. Adverse events were classified using the Clavien-Dindo classification. Outcome measures in the bowel habit diaries after replacement (feasibility) did not differ significantly from outcome measures before replacement. Adverse events occurred in four out of 17 patients (24%): two patients initially showed pocket site pain (Clavien-Dindo Grade I), which resolved without intervention. One patient suffered from poor wound closure (Clavien-Dindo Grade II) and one patient had persisting pocket pain (Clavien-Dindo Grade IIIa) for which a pocket revision was performed. Statistical analyses were performed making paired comparisons using a Wilcoxon signed rank test. The Medtronic Replacement Adaptor 09106 is a valuable option for patients with dynamic graciloplasty or sacral neuromodulation and abdominal IPG and has complication rates similar to replacement of the Interstim without Replacement Adaptor 09106.

Effect of Spinal Cord Burst Stimulation vs Placebo Stimulation on Disability in Patients With Chronic Radicular Pain After Lumbar Spine Surgery

The use of spinal cord stimulation for chronic pain after lumbar spine surgery is increasing, yet rigorous evidence of its efficacy is lacking. To investigate the efficacy of spinal cord burst stimulation, which involves the placement of an implantable pulse generator connected to electrodes with leads that travel into the epidural space posterior to the spinal cord dorsal columns, in patients with chronic radiculopathy after surgery for degenerative lumbar spine disorders. This placebo-controlled, crossover, randomized clinical trial in 50 patients was conducted at St Olavs University Hospital in Norway, with study enrollment from September 5, 2018, through April 28, 2021. The date of final follow-up was May 20, 2022. Patients underwent two 3-month periods with spinal cord burst stimulation and two 3-month periods with placebo stimulation in a randomized order. Burst stimulation consisted of closely spaced, high-frequency electrical stimuli delivered to the spinal cord. The stimulus consisted of a 40-Hz burst mode of constant-current stimuli with 4 spikes per burst and an amplitude corresponding to 50% to 70% of the paresthesia perception threshold. The primary outcome was difference in change from baseline in the self-reported Oswestry Disability Index (ODI; range, 0 points [no disability] to 100 points [maximum disability]; the minimal clinically important difference was 10 points) score between periods with burst stimulation and placebo stimulation. The secondary outcomes were leg and back pain, quality of life, physical activity levels, and adverse events. Among 50 patients who were randomized (mean age, 52.2 [SD, 9.9] years; 27 [54%] were women), 47 (94%) had at least 1 follow-up ODI score and 42 (84%) completed all stimulation randomization periods and ODI measurements. The mean ODI score at baseline was 44.7 points and the mean changes in ODI score were -10.6 points for the burst stimulation periods and -9.3 points for the placebo stimulation periods, resulting in a mean between-group difference of -1.3 points (95% CI, -3.9 to 1.3 points; P = .32). None of the prespecified secondary outcomes showed a significant difference. Nine patients (18%) experienced adverse events, including 4 (8%) who required surgical revision of the implanted system. Among patients with chronic radicular pain after lumbar spine surgery, spinal cord burst stimulation, compared with placebo stimulation, after placement of a spinal cord stimulator resulted in no significant difference in the change from baseline in self-reported back pain-related disability. ClinicalTrials.gov Identifier: NCT03546738.