The Neurostimulation Appropriateness Consensus Committee (NACC)®: Recommendations for the Mitigation of Complications of Neurostimulation.

INTRODUCTION: The International Neuromodulation Society convened a multispecialty group of physicians based on expertise and international representation to establish evidence-based guidance on the mitigation of neuromodulation complications. This Neurostimulation Appropriateness Consensus Committee (NACC)® project intends to update evidence-based guidance and offer expert opinion that will improve efficacy and safety. MATERIALS AND METHODS: Authors were chosen on the basis of their clinical expertise, familiarity with the peer-reviewed literature, research productivity, and contributions to the neuromodulation literature. Section leaders supervised literature searches of MEDLINE, BioMed Central, Current Contents Connect, Embase, International Pharmaceutical Abstracts, Web of Science, Google Scholar, and PubMed from 2017 (when NACC last published guidelines) to October 2023. Identified studies were graded using the United States Preventive Services Task Force criteria for evidence and certainty of net benefit. Recommendations are based on the strength of evidence or consensus when evidence was scant. RESULTS: The NACC examined the published literature and established evidence- and consensus-based recommendations to guide best practices. Additional guidance will occur as new evidence is developed in future iterations of this process. CONCLUSIONS: The NACC recommends best practices regarding the mitigation of complications associated with neurostimulation to improve safety and efficacy. The evidence- and consensus-based recommendations should be used as a guide to assist decision-making when clinically appropriate.

Open and Percutaneous Trigeminal Nucleotractotomy: A Case Series and Literature Review.

INTRODUCTION: Nucleotractotomy is an efficient surgical technique that provides a high pain relief rate for specific clinical indications. There are two main approaches for performing this operation: an open and percutaneous technique. METHODS: In the Federal Center of Neurosurgery (Novosibirsk, Russia) from 2016 to 2022, 13 trigeminal nucleotractotomies (7 open and 6 percutaneous) were performed in 12 patients (5 women and 7 men). The indications for surgery were deafferentation pain and chronic drug-resistant pain syndrome caused by malignancy in the facial region. A neurological examination was done on each patient 1 day before the surgery, right after the surgery, and at the follow-up (examinations were done after 1, 6, and 12 months, or when the patient independently applied to our hospital). In the early postoperative period, patients underwent brain MRI. RESULTS: The average pain intensity score before nucleotractotomy on the 11-point (0-10) visual analog scale (VAS) was 9.3. The effectiveness of open interventions was somewhat higher; the average VAS score in the early postoperative period for the open technique was 1.57, in the group of patients who underwent percutaneous nucleotractotomy were 2.66. Complete regression of the pain syndrome was achieved in 6 patients; in 5 patients, the pain in the face decreased by more than 50%. One case had an unsatisfactory outcome. In the open-surgery group in the early postoperative period, according to MRI, the average length of the visualized area of signal change was longer (21.5 mm, the average diameter was 3.75 mm) than in a percutaneous nucleotractotomy group (16 mm, the average diameter was 3.75 mm). During the postoperative period (average follow-up 40 months), the pain recurred in 3 patients (30%): 2 patients after percutaneous nucleotractotomy (3 and 18 months after surgery) and in 1 patient 4 months after the open surgery. The mean VAS score at the last follow-up was 2.6. CONCLUSION: Trigeminal nucleotractotomy is an effective approach to the treatment of intractable facial pain. Our experience suggests this technique is highly effective in patients with drug-resistant pain caused by craniofacial tumors and deafferentation conditions after treating trigeminal neuralgia.

Applications of brain-computer interfaces in neurodegenerative diseases.

Brain-computer interfaces (BCIs) provide the central nervous system with channels of direct communication to the outside world, without having to go through the peripheral nervous system. Neurodegenerative diseases (NDs) are notoriously incurable and burdensome medical conditions that will result in progressive deterioration of the nervous system. The applications of BCIs in NDs have been studied for decades now through different approaches, resulting in a considerable amount of literature in all related areas. In this study, we begin by introducing BCIs and proceed by explaining the principles of BCI-based neurorehabilitation. Then, we go through four specific types of NDs, including amyotrophic lateral sclerosis, Parkinson's disease, Alzheimer's disease, and spinal muscular atrophy, and review some of the applications of BCIs in the neural rehabilitation of these diseases. We conclude with a discussion of the characteristics, challenges, and future possibilities of research in the field. Going through the uses of BCIs in NDs, we can see that approaches and strategies employed to tackle the wide range of limitations caused by NDs are numerous and diverse. Furthermore, NDs can fall under different categories based on the target area of neurodegeneration and thus require different methods of BCI-based rehabilitation. In recent years, neurotechnology companies have substantially invested in research on BCIs, focusing on commercializing BCIs and bringing BCI-based technologies from bench to bedside. This can mean the beginning of a new era for BCI-based neurorehabilitation, with an anticipated spike in interest among researchers, practitioners, engineers, and entrepreneurs alike.

Remote Management of Spinal Cord Stimulation Devices for Chronic Pain: Expert Recommendations on Best Practices for Proper Utilization and Future Considerations.

OBJECTIVE: Emerging spinal cord stimulation (SCS) remote monitoring and programming technologies provide a unique opportunity to address challenges of in-person visits and improve patient care, although clinical guidance on implementation is needed. The goal of this document is to establish best clinical practices for integration of remote device management into the care of patients with SCS, including remote monitoring and remote programming. MATERIALS AND METHODS: A panel of experts in SCS met in July 2022, and additional experts contributed to the development of recommendations after the meeting via survey responses and correspondence. RESULTS: Major goals of remote SCS device management were identified, including prompt identification and resolution of SCS-related issues. The panel identified metrics for remote monitoring and classified them into three categories: device-related (eg, stimulation usage); measurable physiologic or disease-related (eg, patient physical activity or pedometry); and patient-reported (eg, sleep quality and pain intensity). Recommendations were made for frequency of reviewing remote monitoring metrics, although providers should tailor follow-up to individual patient needs. Such periodic reviews of remote monitoring metrics would occur separately from automatic monitoring system notifications (if key metrics fall outside an acceptable range). The guidelines were developed in consideration of reimbursement processes, privacy concerns, and the responsibilities of the care team, industry professionals, manufacturers, patients, and caregivers. Both existing and needed clinical evidence were covered, including outcomes of interest for future studies. CONCLUSIONS: Given the expansion of SCS device capabilities, this document provides critical guidance on best practices for using remote device management, although medical necessity should drive all remote monitoring decisions, with individualized patient care. The authors also describe the potential of these emerging technologies to improve outcomes for patients with SCS, although more clinical evidence is needed.

Educational Curriculum for Peripheral Nerve Stimulation Developed by the North American Neuromodulation Society.

BACKGROUND: Peripheral nerve stimulation (PNS) is an effective neuromodulation therapy for chronic neuropathic and nociceptive pain. Although the total number of PNS implantations has increased over the last decade, no curriculum exists to guide training and learning of this therapy. The goal of the North American Neuromodulation Society (NANS) education committee is to develop a series of competency-based curriculums for neuromodulation therapies. The PNS curriculum is the latest part of such series, following the curriculums for spinal cord stimulation and intrathecal drug delivery system. MATERIALS AND METHODS: A multidisciplinary task force (anesthesiology, physical medicine and rehabilitation, neurosurgery, preventive medicine and public health, and neurology) was created by the educational committee of NANS to develop a PNS curriculum in accordance with the Accreditation Council for Graduate Medical Education (ACGME) milestones. The curriculum was created based on the best available evidence and expert knowledge (from our task force members) of available PNS systems. The final PNS curriculum was approved by the NANS board. RESULTS: A PNS curriculum was developed by the task force. Milestones included professionalism, practice-based learning, interpersonal communication, medical knowledge, systems-based practice, procedural skills, and patient care. Each milestone was defined into three categories: early learner, advanced learner, and practitioner. CONCLUSIONS: This manuscript provides a PNS training curriculum developed by a multidisciplinary task force of the NANS educational committee in accordance with the milestones described by ACGME for basic learners, advanced learners, and practitioners. This curriculum will help provide a structured training and evaluation process for obtaining proficiency in PNS treatment(s).

Minimally invasive procedures for hypothalamic hamartoma-related epilepsy: a systematic review and meta-analysis.

OBJECTIVE: Hypothalamic hamartoma (HH) is a rare, nonmalignant, heterotopic developmental malformation that consists of a mixture of normal neurons and glial cells. Resection of HHs has been associated with high rates of mortality and morbidity. Therefore, minimally invasive ablation methods could be the best treatment option for HH. The most frequently used minimally invasive options for HH ablation are radiofrequency thermocoagulation (RFT), laser ablation (LA), and stereotactic radiosurgery. METHODS: To investigate three minimally invasive procedures in the treatment of refractory seizures related to HH, the authors conducted a systematic search in March 2022 in the MEDLINE, Embase, Scopus, and Web of Science databases in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. Seizure freedom was the primary outcome of interest. The authors defined seizure freedom as Engel class I or International League Against Epilepsy class 1 or 2 or as the reported term "seizure freedom." The secondary outcome was long-term complications reported in studies. Both random- and fixed-effects models were used to calculate the pooled proportion of seizure freedom and complication rate with 95% confidence intervals. A modified version of the Joanna Briggs Institute (JBI) Critical Appraisal to assess the risk of bias was used. RESULTS: The authors included 15 studies with 422 patients (RFT, n = 190; LA, n = 171; and Gamma Knife Radiosurgery [GKRS], n = 61). Generally, the mean incidences of overall seizure freedom after minimally invasive procedures were 77% (95% CI 0.74-0.81) and 68% (95% CI 0.57-0.79) using fixed- and random-effects models, respectively. The mean incidence of overall seizure freedom after RFT was 69% (95% CI 0.63-0.75), and the mean incidences of overall seizure freedom after LA and GKRS were 87% (95% CI 0.82-0.92) and 44% (95% CI 0.32-0.57), respectively. The total complication rate with minimally invasive procedures was 13% (95% CI 0.01-0.26). The complication rate in each treatment was as follows: 5% (95% CI 0.0-0.12) for RFT, 20% (95% CI 0.0-0.47) for LA, and 22% (95% CI 0-0.65) for GKRS. Meta-regression analysis showed an association between older age and higher complication rates in the LA group. CONCLUSIONS: In this meta-analysis, LA showed superiority in seizure freedom over the other two methods. The complication rate associated with RFT was less than those in the other two methods; however, this difference was not statistically significant.

Cervical spinal cord stimulation for prevention and treatment of cerebral vasospasm after aneurysmal subarachnoid hemorrhage: clinical and radiographic outcomes of a prospective single-center clinical pilot study.

BACKGROUND: Cerebral vasospasm induced by aneurysmal subarachnoid hemorrhage (aSAH) is a major cause of high morbidity and mortality, for which there is no consistently effective treatment. Cervical spinal cord stimulation (cSCS) has been shown to induce vasodilatation and improve peripheral and cerebral blood flow in both animal and human studies. This pilot study was performed to assess the clinical effect and long-term results of cSCS treatment in aSAH patients. METHODS: This was the first IRB- and US FDA-approved prospective non-randomized non-controlled study comprising of 12 aSAH patients (8 women, 4 men, age range 34-62 years) treated between May and November 2008. All patients underwent up to 2 weeks of cSCS with a single percutaneously implanted 8-contact electrode. Neurological outcomes at discharge and follow-up of up to 13 years and mortality/complications rates were analyzed. RESULTS: All 12 aSAH patients underwent cSCS electrode implantation immediately after securing the aneurysm. Patients were stimulated for 10-14 consecutive days starting within 3 days of aneurysm rupture. Angiographic vasospasm occurred in six patients; two patients developed new vasospasm-related neurological symptoms; both recovered completely by discharge time. One patient died from unrelated multi-system failure; the rest were followed up clinically (average, 7.5 years; range, 12-151 months) and angiographically (average, 6.5 years; range, 36-125 months). No delayed ischemic neurological deficits/strokes and no cSCS-related adverse effects were observed. CONCLUSIONS: Our short- and long-term data suggest that cSCS is feasible and safe for patients in the acute aSAH settings. Small size of the patient cohort and lack of control do not allow us to conclude whether cSCS is able to prevent cerebral vasospasm, decrease its severity, and improve clinical outcomes in aSAH patients. However, our findings support further clinical trials and development of cSCS as a new concept to prevent and treat cerebral vasospasm. CLINICALTRIALS: gov NCT00766844, posted on 10/06/2008.

The Neurostimulation Appropriateness Consensus Committee (NACC): Recommendations on Best Practices for Cervical Neurostimulation.

INTRODUCTION: The International Neuromodulation Society convened a multispecialty group of physicians based on expertise with international representation to establish evidence-based guidance on the use of neurostimulation in the cervical region to improve outcomes. This Neurostimulation Appropriateness Consensus Committee (NACC) project intends to provide evidence-based guidance for an often-overlooked area of neurostimulation practice. MATERIALS AND METHODS: Authors were chosen based upon their clinical expertise, familiarity with the peer-reviewed literature, research productivity, and contributions to the neuromodulation literature. Section leaders supervised literature searches of MEDLINE, BioMed Central, Current Contents Connect, Embase, International Pharmaceutical Abstracts, Web of Science, Google Scholar, and PubMed from 2017 (when NACC last published guidelines) to the present. Identified studies were graded using the US Preventive Services Task Force criteria for evidence and certainty of net benefit. Recommendations are based on the strength of evidence or consensus when evidence was scant. RESULTS: The NACC examined the published literature and established evidence- and consensus-based recommendations to guide best practices. Additional guidance will occur as new evidence is developed in future iterations of this process. CONCLUSIONS: The NACC recommends best practices regarding the use of cervical neuromodulation to improve safety and efficacy. The evidence- and consensus-based recommendations should be utilized as a guide to assist decision making when clinically appropriate.

A Systematic Literature Review of Brain Neurostimulation Therapies for the Treatment of Pain.

OBJECTIVE: To conduct a systematic literature review of brain neurostimulation for pain. DESIGN: Grade the evidence for deep brain neurostimulation (DBS). METHODS: An international, interdisciplinary work group conducted a literature search for brain stimulation. Abstracts were reviewed to select studies for grading. Randomized controlled trials (RCTs) meeting inclusion/exclusion criteria were graded by two independent reviewers. General inclusion criteria were prospective trials (RCTs and observational) that were not part of a larger or previously reported group. Excluded studies were retrospective or existed only as abstracts. Studies were graded using the modified Interventional Pain Management Techniques-Quality Appraisal of Reliability and Risk of Bias Assessment, the Cochrane Collaborations Risk of Bias assessment, and the United States Preventative Services Task Force level-of-evidence criteria. RESULTS: Two high-quality RCTs and three observational trials supported DBS, resulting in Level II (moderate) evidence. CONCLUSION: Moderate evidence supports DBS to treat chronic pain. Additional Level I RCTs are needed to further the strength of the evidence in this important area of medicine, but the current evidence suggests that DBS should be considered as an option in treating complex pain cases.

A Systematic Literature Review of Peripheral Nerve Stimulation Therapies for the Treatment of Pain.

OBJECTIVE: To conduct a systematic literature review of peripheral nerve stimulation (PNS) for pain. DESIGN: Grade the evidence for PNS. METHODS: An international interdisciplinary work group conducted a literature search for PNS. Abstracts were reviewed to select studies for grading. Inclusion/exclusion criteria included prospective randomized controlled trials (RCTs) with meaningful clinical outcomes that were not part of a larger or previously reported group. Excluded studies were retrospective, had less than two months of follow-up, or existed only as abstracts. Full studies were graded by two independent reviewers using the modified Interventional Pain Management Techniques-Quality Appraisal of Reliability and Risk of Bias Assessment, the Cochrane Collaborations Risk of Bias assessment, and the US Preventative Services Task Force level-of-evidence criteria. RESULTS: Peripheral nerve stimulation was studied in 14 RCTs for a variety of painful conditions (headache, shoulder, pelvic, back, extremity, and trunk pain). Moderate to strong evidence supported the use of PNS to treat pain. CONCLUSION: Peripheral nerve stimulation has moderate/strong evidence. Additional prospective trials could further refine appropriate populations and pain diagnoses.

A Systematic Literature Review of Dorsal Root Ganglion Neurostimulation for the Treatment of Pain.

OBJECTIVE: To conduct a systematic literature review of dorsal root ganglion (DRG) stimulation for pain. DESIGN: Grade the evidence for DRG stimulation. METHODS: An international, interdisciplinary work group conducted a literature search for DRG stimulation. Abstracts were reviewed to select studies for grading. General inclusion criteria were prospective trials (randomized controlled trials and observational studies) that were not part of a larger or previously reported group. Excluded studies were retrospective, too small, or existed only as abstracts. Studies were graded using the modified Interventional Pain Management Techniques-Quality Appraisal of Reliability and Risk of Bias Assessment, the Cochrane Collaborations Risk of Bias assessment, and the US Preventative Services Task Force level-of-evidence criteria. RESULTS: DRG stimulation has Level II evidence (moderate) based upon one high-quality pivotal randomized controlled trial and two lower-quality studies. CONCLUSIONS: Moderate-level evidence supports DRG stimulation for treating chronic focal neuropathic pain and complex regional pain syndrome.

A Systematic Literature Review of Spine Neurostimulation Therapies for the Treatment of Pain.

OBJECTIVE: To conduct a systematic literature review of spinal cord stimulation (SCS) for pain. DESIGN: Grade the evidence for SCS. METHODS: An international, interdisciplinary work group conducted literature searches, reviewed abstracts, and selected studies for grading. Inclusion/exclusion criteria included randomized controlled trials (RCTs) of patients with intractable pain of greater than one year's duration. Full studies were graded by two independent reviewers. Excluded studies were retrospective, had small numbers of subjects, or existed only as abstracts. Studies were graded using the modified Interventional Pain Management Techniques-Quality Appraisal of Reliability and Risk of Bias Assessment, the Cochrane Collaborations Risk of Bias assessment, and the US Preventative Services Task Force level-of-evidence criteria. RESULTS: SCS has Level 1 evidence (strong) for axial back/lumbar radiculopathy or neuralgia (five high-quality RCTs) and complex regional pain syndrome (one high-quality RCT). CONCLUSIONS: High-level evidence supports SCS for treating chronic pain and complex regional pain syndrome. For patients with failed back surgery syndrome, SCS was more effective than reoperation or medical management. New stimulation waveforms and frequencies may provide a greater likelihood of pain relief compared with conventional SCS for patients with axial back pain, with or without radicular pain.

Redefining Spinal Cord Stimulation "Trials": A Randomized Controlled Trial Using Single-Stage Wireless Permanent Implantable Devices.

BACKGROUND: "Traditional" spinal cord stimulation (SCS) trials with percutaneous electrodes externalized to a pulse generator (PG) are typically limited in duration due to risk of infection. Newer miniaturized wireless SCS technology eliminates the percutaneous extension (as well as PGs implanted for chronic use), thus facilitating a single-stage implantation after which the device can remain indefinitely. OBJECTIVE: To evaluate fully implanted wireless SCS devices during a 30-day screening trial in subjects with chronic low back pain and leg pain and a history of lumbosacral spine surgery. METHODS: In a randomized controlled trial of single-stage wireless SCS using a wireless percutaneous system, 99 subjects received either 10 kHz high frequency stimulation (HFS) or lower frequency stimulation (LFS) below 1500 Hz (Bolash R, Creamer M, Rauck R, et al. Wireless high frequency spinal cord stimulation (10 kHz) compared to multi-waveform low frequency spinal cord stimulation in the management of chronic pain in failed back surgery syndrome subjects: preliminary results of a multicenter, prospective, randomized controlled study. Pain Med 2019, https://doi.org/10.1093/pm/pnz019). In this report, we assess the 30-day trial success rate (≥50% pain relief from baseline) and complications. RESULTS: The overall trial success rate was 88% (87/99): 92% (46/50) for HFS and 84% (41/49) for LFS (NS). The trial success rate in the 64 subjects with predominant low back pain was 92% (59/64) vs. 80% (28/35) in those with leg pain ≥ low back pain (NS). During the screening trial, one infection occurred (1%) and one subject withdrew and was explanted (1%). Electrode migrations were seen on routine follow-up x-rays in 10 cases (10%). CONCLUSION: Using wireless SCS devices that allow for an extended trial period and evaluation of various waveforms, we observed a high rate trial success rate with both HFS and LFS waveforms, with minimal incidence of infection. Long-term follow-up will address the cost-effectiveness and morbidity associated with this technology, which facilitates single-stage treatment.

Peripheral Nerve Field Stimulation for Chronic Back Pain: Therapy Outcome Predictive Factors.

OBJECTIVE: To identify variables that influence pain reduction following peripheral nerve field stimulation (PNFS) in order to identify a potential responder profile. METHODS: Exploratory univariate and multivariate (random forest) analyses were performed separately on 2 randomized controlled trials and a registry; all included patients with chronic back pain, mainly failed back surgery syndrome. An international expert panel judged the clinical relevance of variables to identify responders by consensus. RESULTS: Variables identified that may help predict PNFS success in patients with back pain include patient and pain characteristics (age, time since onset of pain and spinal surgery, pain medication history, position and size of pain area, pain severity, mixed nociceptive/neuropathic pain, health-related quality of life, depression, functional disability, and leg pain status), implant procedure variables (the number and position of leads, paresthesia coverage, and amount of pain relief during the trial), and programming (number of programs, cathodes, and anodes; pulse rate; pulse width; and percentage of device usage). CONCLUSIONS: While these analyses are exploratory and restricted to a limited sample size, they suggest variables that may play a role in predicting a therapeutic response. These results, however, are informative only and should be cautiously interpreted. Future research to validate the variables in a clinical study is needed.

Frame-based radiosurgery of multiple metastases using single-isocenter volumetric modulated arc therapy technique.

Single-isocenter volumetric modulated arc therapy (VMAT) technique can provide stereotactic radiosurgery (SRS) treatment with improved delivery efficiency for treating multiple metastases. Nevertheless, planning is time consuming and verification of frame-based SRS setup, especially at noncoplanar angles, can be challenging. We report on a single-isocenter VMAT technique with a special focus on improving treatment workflow and delivery verification to exploit the minimized patient motion of the frame-based SRS. We developed protocols for preplanning and verification for VMAT and evaluated them for ten patient cases. Preplans based on MRI were used to generate comparable treatment plans using CT taken on the day of treatment after frame placement. Target positioning accuracy was evaluated by stereoscopic in-room kV imaging. Dosimetric accuracy of the noncoplanar plan delivery was validated using measurement-guided 3D dose reconstruction as well as film-based end-to-end test with a Rando phantom. Average absolute differences of homogeneity indices, conformity indices, and V12Gy between MR preplans and CT-based plans were within 5%. In-room imaging positioning accuracy of 0.4 mm was verified to be independent of the distance to the isocenter. For treatment verification, average local and global passing rates of the 3D gamma (1 mm, 3%) were 86% and 99%, respectively. D99 values were matched within 5% for individual target structures (>0.5 cc). Additional film analysis confirmed dosimetric accuracy for small targets that had large verification errors in the 3D dose reconstruction. Our results suggest that the advantages of frame-based SRS and noncoplanar single-isocenter VMAT technique can be combined for efficient and accurate treatment of patients with multiple metastases.

Motor Cortex Stimulation for Deafferentation Pain.

PURPOSE OF REVIEW: Since the early 1990s, motor cortex stimulation (MCS) has been a unique treatment modality for patients with drug-resistant deafferentation pain. While underpowered studies and case reports have limited definitive, data-driven analysis of MCS in the past, recent research has brought new clarity to the MCS literature and has helped identify appropriate indications for MCS and its long-term efficacy. RECENT FINDINGS: In this review, new research in MCS, repetitive transcranial magnetic stimulation (rTMS), and transcranial direct current stimulation (tDCS) are analyzed and compared with historical landmark papers. Currently, MCS is effective in providing relief to 40-64% of patients, with decreasing analgesic effect over time addressed by altering stimulation settings. rTMS and tDCS, two historic, non-invasive stimulation techniques, are providing new alternatives for the treatment of deafferentation pain, with rTMS finding utility in identifying MCS responders. Future advances in electrode arrays, neuro-navigation, and high-definition tDCS hold promise in providing pain relief to growing numbers of patients. Deafferentation pain is severe, disabling, and remains a challenge for patients and providers alike. Over the last several years, the MCS literature has been revitalized with studies and meta-analyses demonstrating MCS effectiveness and providing guidance in identifying responders. At the same time, rTMS and tDCS, two time-honored non-invasive stimulation techniques, are finding new utility in managing deafferentation pain and identifying good MCS candidates. As the number of potential therapies grow, the clinician's role is shifting to personalizing treatment to the unique pain of each patient. With new treatment modalities, this form of personalized medicine is more possible than ever before.

Who May Benefit From On-Demand Control of Deep Brain Stimulation? Noninvasive Evaluation of Parkinson Patients.

BACKGROUND: In closed-loop on-demand control (ODC) of deep brain stimulation (DBS), stimulation is applied only when symptoms appear. Following stimulation of a fixed duration, DBS is switched off until the symptoms reappear. By repeating these demand-driven cycles, the amount of stimulation delivered can be decreased, thereby reducing DBS side-effects and improving battery-life of the pulse-generator. This article introduces Ro metric for quantification of degree of benefit of ODC and explores candidate selection in tremor-dominant Parkinson's disease (PD). METHOD: The study was performed on nine PD patients previously implanted with Medtronic DBS systems. Accelerometer sensor was placed on the tremor-dominant hand to detect onset of tremor. Fixed duration of stimulation (DS) of 20-80 sec was applied. Once the tremor was observed, stimulation was switched on. These trials were repeated during resting, postural, and kinetic conditions. Ro metric was calculated as the ratio of stimulation-off tremor-free period to the DS. Ro calculated at different DS were compared for each patient. RESULTS: We found that for each patient, Ro varied with DS and an optimal DS* gave a higher percentage of stimulation-off time. Average Ro at DS* varied from 0.554 to 4.24 for eight patients giving 35%-80% stimulation-off time. CONCLUSIONS: Ro values can be used for selection of optimal DS* in ODC. Three of nine patients were found to be tremor-free without stimulation for >50% of total time with even up to 80% in one patient. Patients with low Ro may not benefit from ODC in DBS, where the trade-off between having side-effects and using ODC system will need to be assessed.

Success Using Neuromodulation With BURST (SUNBURST) Study: Results From a Prospective, Randomized Controlled Trial Using a Novel Burst Waveform.

OBJECTIVE: The purpose of the multicenter, randomized, unblinded, crossover Success Using Neuromodulation with BURST (SUNBURST) study was to determine the safety and efficacy of a device delivering both traditional tonic stimulation and burst stimulation to patients with chronic pain of the trunk and/or limbs. METHODS: Following a successful tonic trial, 100 subjects were randomized to receive one stimulation mode for the first 12 weeks, and then the other stimulation mode for the next 12 weeks. The primary endpoint assessed the noninferiority of the within-subject difference between tonic and burst for the mean daily overall VAS score. An intention-to-treat analysis was conducted using data at the 12- and 24-week visits. Subjects then used the stimulation mode of their choice and were followed for one year. Descriptive statistics were used analyze additional endpoints and to characterize the safety profile of the device. RESULTS: The SUNBURST study demonstrated that burst stimulation is noninferior to tonic stimulation (p < 0.001). Superiority of burst was also achieved (p < 0.017). Significantly more subjects (70.8%) preferred burst stimulation over tonic stimulation (p < 0.001). Preference was sustained through one year: 68.2% of subjects preferred burst stimulation, 23.9% of subjects preferred tonic, and 8.0% of subjects had no preference. No unanticipated adverse events were reported and the safety profile was similar to other spinal cord stimulation studies. CONCLUSIONS: The SUNBURST study demonstrated that burst spinal cord stimulation is safe and effective. Burst stimulation was not only noninferior but also superior to tonic stimulation for the treatment of chronic pain. A multimodal stimulation device has advantages.