Spinal Cord Stimulation for Chronic Pain
(DYNAMO Trial)
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Ashwin Viswanathan
Disqualifiers: Cancer, Obesity, Infection, Cognitive impairment, others
No Placebo Group
Approved in 1 Jurisdiction
Trial Summary
What is the purpose of this trial?The goal of this study is to compare pain outcomes achieved by spinal cord stimulation (SCS) using time varying stimulation patterns with pain outcomes achieved by current standard of care SCS.
Will I have to stop taking my current medications?
The trial requires that you keep your pain-related medications stable for 4 weeks before starting and during the study, meaning you shouldn't increase or add new pain medications during this time.
What data supports the effectiveness of the treatment Boston Scientific WaveWriter Alpha Spinal Cord Stimulator for chronic pain?
Research shows that spinal cord stimulation, including advanced systems like the WaveWriter Alpha, is effective for managing chronic pain. Studies highlight that multi-channel devices and new stimulation waveforms can provide significant pain relief and improve daily activities for many patients.
12345Is spinal cord stimulation generally safe for humans?
Spinal cord stimulation (SCS) is generally considered safe for treating chronic pain, with common complications including lead migration, lead breakage, infection, and pain over the implant. It is a reversible surgical treatment, and while the exact mechanisms are not fully understood, it has been used for various conditions with success rates between 50-75% when performed by experienced professionals.
678910How is the WaveWriter Alpha Spinal Cord Stimulator treatment different from other treatments for chronic pain?
The WaveWriter Alpha Spinal Cord Stimulator is unique because it offers burst stimulation, which reduces pain without causing paresthesia (a tingling sensation), unlike traditional spinal cord stimulation that often induces this sensation.
611121314Eligibility Criteria
This trial is for adults over 22 with chronic pain in the trunk or limbs, lasting at least 6 months and scoring above a 6 on the pain scale. Participants must have tried multiple treatments without success, be stable on current medications, not had recent back surgery, and pass psychological screening. Women of childbearing age must use contraception. Exclusions include high surgical risk patients, those with cognitive impairments or certain medical conditions.Inclusion Criteria
My back pain moderately to severely affects my daily activities.
Eligible candidate for SCS from a psychological and psychiatric standpoint as determined within 180 days prior to Baseline Visit, per site's routine screening process
Able to independently read and complete all questionnaires and assessments provided in English
+11 more
Exclusion Criteria
You have had a problem with using drugs or alcohol in the six months before the study starts.
I often feel my pain is unbearable, rating it a 10 out of 10.
Significant cognitive impairment at Screening that, in the opinion of the Investigator, would reasonably be expected to impair the study candidate's ability to participate in the study
+14 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive spinal cord stimulation using either time invariant pulse (TIP) or time variant pulse (TVP) stimulation patterns
8±3 weeks
Follow-up
Participants are monitored for therapy efficacy and safety through long-term follow-up, using multiple pain assessments and at-home digital data collection
Long-term
Participant Groups
The study tests new spinal cord stimulation (SCS) patterns against standard SCS to see which better reduces chronic pain. Candidates will receive an implantable device that delivers electrical pulses to the spine, aiming to alleviate their discomfort by altering nerve activity.
2Treatment groups
Experimental Treatment
Active Control
Group I: Time Variant Pulse (TVP) StimulationExperimental Treatment1 Intervention
The time variant pulse (TVP) stimulation will serve as the experimental arm for this study. There are two ways of delivering TVP stimulation to the spinal cord. TVP stimulation can either vary in intensity or it can vary rate, referred to as intensity-modulated TVP or rate-modulated TVP, respectively.
Group II: Time Invariant Pulse(TIP) StimulationActive Control1 Intervention
The control arm for this study will be the Time Invariant Pulse stimulation which is used in standard of care Spinal Cord Stimulation therapy. TIP tonic stimulation is delivered with fixed amplitude, pulse width, and frequency parameters.
Boston Scientific WaveWriter Alpha Spinal Cord Stimulator is already approved in United States for the following indications:
🇺🇸 Approved in United States as WaveWriter Alpha for:
- Chronic intractable pain of the trunk and/or limbs
- Failed back surgery syndrome
- Complex Regional Pain Syndrome (CRPS) Types I and II
- Intractable low back pain and leg pain
- Radicular pain syndrome
- Radiculopathies resulting in pain secondary to failed back syndrome or herniated disc
- Epidural fibrosis
- Degenerative disc disease
- Arachnoiditis
- Multiple back surgeries
- Diabetic peripheral neuropathy of the lower extremities
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Baylor College of MedicineHouston, TX
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Who Is Running the Clinical Trial?
Ashwin ViswanathanLead Sponsor
National Institute of Neurological Disorders and Stroke (NINDS)Collaborator
Boston Scientific CorporationIndustry Sponsor
References
Patient-interactive, computer-controlled neurological stimulation system: clinical efficacy in spinal cord stimulator adjustment. [2004]Over the past 20 years, continuing technical advances have rendered spinal cord stimulation an easily implemented low-morbidity technique for the management of chronic intractable pain in properly selected patients. Percutaneous methods for the insertion of arrays of multiple epidural electrodes, which are driven by noninvasively programmable "multichannel" implanted devices, have been among the most important of these technical improvements. The same implanted electronics may be used with peripheral nerve or intracerebral electrodes. If the capabilities of this new hardware are to be used to full advantage, a major investment of time and effort is required to adjust the system postoperatively for optimum effect. Ideally, these adjustments should be based upon psychophysical data, obtained in a manner that minimizes influences such as potential operator bias or stimulus presentation-order effects. These requirements have been met by the development of a computerized system designed for direct patient interaction and for greater ease of operation than the standard external devices used with these implants. The system has been tested clinically in 25 patients with spinal cord stimulation for pain. It rapidly tests the available electrode combinations and stimulus pulse parameters at a rate comparable to or greater than that of a skilled human operator using the standard device. It records detailed graphic data and patient analog ratings at varying thresholds and implements "pain drawing" methods with novel input and analytical techniques. This patient-interactive computerized system has proved to be safe and effective clinically. The time required by the average patient working with this system to adjust the stimulator is comparable to or less than the time required by the same patient working with a physician's assistant. Psychophysical data collected by the system may be correlated with clinical observations. Ongoing development will permit delivery of novel pulse sequences and protocols to assess the mechanisms by which stimulation affords relief from pain.
Real World Clinical Utility of Neurophysiological Measurement Utilizing Closed-Loop Spinal Cord Stimulation in a Chronic Pain Population: The ECAP Study Protocol. [2023]Spinal cord stimulation (SCS) is an established chronic pain treatment, but the effectiveness of traditional, open-loop paradigms has been plagued by variable sustainability in a real-world setting. A new approach, utilizing evoked compound action potential (ECAP) controlled closed-loop (CL) SCS, continuously monitors spinal cord activation and automatically adjusts the stimulation amplitude of every pulse, maintaining stimulation at the prescribed ECAP level through this continual feedback mechanism. Recent studies demonstrated the long-term safety and efficacy of ECAP-controlled CL-SCS. Here, we report the design of a prospective, multicenter, single-arm feasibility study to characterize clinical outcomes in a real-world chronic pain population utilizing ECAP-controlled CL-SCS. Objective neurophysiological measurements such as device performance and patient therapy compliance, will be analyzed against baseline biopsychosocial assessments, to explore the clinical utility of these objective physiologic biomarkers in patient phenotyping.
Spinal cord stimulation for chronic, intractable pain: superiority of "multi-channel" devices. [2021]Spinal cord stimulation has evolved over the past 20 years into an easily implemented technique, with low morbidity, for the treatment of intractable, chronic pain in properly selected patients. We report our experience with a series of 62 patients implanted between 1983 and 1987, with percutaneous and laminectomy electrodes, and with single- and "multi-channel" (programmable, multi-contact) devices. Fifty had chronic, intractable low back and leg pain ("failed back surgery syndrome," lumbar arachnoid fibrosis), five had spinal cord injuries, and seven "peripheral" pathology or stump pain. Statistical analysis of these and other patient characteristics and technical factors was undertaken to identify predictors of outcome. All patients were interviewed by a disinterested third party at a mean of 2.14 years following implantation. A majority of patients reported at least 50% sustained relief of pain and indicated that they would go through the procedure again for the same result. There was corresponding improvement in ability to perform various everyday activities, and decrease in use of analgesics. Ten of 40 failed back patients who were disabled before the procedure returned to work postoperatively. Superposition of stimulation paresthesias upon a patient's topography of pain was found to be a statistically significant predictor of successful relief of pain, by linear regression methods. Univariate and multivariate analysis of patient characteristics and technical factors as predictors of outcome demonstrated significant advantages for female patients, and for patients implanted with "multi-channel" devices. With these devices, electrode geometries with central cathode(s) flanked by rostral and caudal anode(s) were favored disproportionately. Technical improvements in implanted spinal cord stimulation devices, in particular the development of multi-contact percutaneous electrode arrays and supporting programmable electronics, have significantly improved clinical results.
A Novel, Paresthesia-Free Spinal Cord Stimulation Waveform for Chronic Neuropathic Low Back Pain: Six-Month Results of a Prospective, Single-Arm, Dose-Response Study. [2023]The aim of this prospective, single-blinded, dose-response study was to evaluate the safety and efficacy of a novel, paresthesia-free (subperception) spinal cord stimulation (SCS) waveform designed to target dorsal horn dendrites for the treatment of chronic neuropathic low back pain (LBP).
The Challenge of Converting "Failed Spinal Cord Stimulation Syndrome" Back to Clinical Success, Using SCS Reprogramming as Salvage Therapy, through Neurostimulation Adapters Combined with 3D-Computerized Pain Mapping Assessment: A Real Life Retrospective Study. [2022]While paresthesia-based Spinal Cord Stimulation (SCS) has been proven effective as treatment for chronic neuropathic pain, its initial benefits may lead to the development of "Failed SCS Syndrome' (FSCSS) defined as decrease over time related to Loss of Efficacy (LoE) with or without Loss of Coverage (LoC). Development of technologies associating new paresthesia-free stimulation waveforms and implanted pulse generator adapters provide opportunities to manage patients with LoE. The main goal of our study was to investigate salvage procedures, through neurostimulation adapters, in patients already implanted with SCS and experiencing LoE. We retrospectively analyzed a cohort of patients who were offered new SCS programs/waveforms through an implanted adapter between 2018 and 2021. Patients were evaluated before and at 1-, 3-, 6- and 12-month follow-ups. Outcomes included pain intensity rating with a Visual Analog Scale (VAS), pain/coverage mappings and stimulation preferences. Last follow-up evaluations (N = 27) showed significant improvement in VAS (p = 0.0001), ODI (p = 0.021) and quality of life (p = 0.023). In the 11/27 patients with LoC, SCS efficacy on pain intensity (36.89%) was accompanied via paresthesia coverage recovery (55.57%) and pain surface decrease (47.01%). At 12-month follow-up, 81.3% preferred to keep tonic stimulation in their waveform portfolio. SCS conversion using adapters appears promising as a salvage solution, with an emphasis on paresthesia recapturing enabled via spatial retargeting. In light of these results, adapters could be integrated in SCS rescue algorithms or should be considered in SCS rescue.
Spinal cord stimulation: Background and clinical application. [2022]Background Spinal cord stimulation (SCS) is a surgical treatment for chronic neuropathic pain refractory to conventional treatment. SCS treatment consists of one or more leads implanted in the epidural space of the spinal canal, connected to an implantable pulse generator (IPG). Each lead carries a number of contacts capable of delivering a weak electrical current to the spinal cord, evoking a feeling of peripheral paresthesia. With correct indication and if implanted by an experienced implanter, success rates generally are in the range of about 50-75%. Common indications include complex regional pain syndrome (CRPS I), angina pectoris, and radicular pain after failed back surgery syndrome, and the treatment is also used to treat stump pain after amputation, and pain due to peripheral nerve injury, peripheral vascular disease, and diabetic neuropathy. Recommended contraindications for the treatment include pregnancy, coagulopathy, severe addiction to psychoactive substances, and lack of ability to cooperate (e.g. due to active psychosis or cognitive impairment). Most common complications to the treatment include lead migration, lead breakage, infection, pain over the implant, and dural puncture. Despite extensive research in the area, the mechanisms of action are still only partially understood. Methods In this topical review the historical background behind the treatment is described and the current theories on the mechanism of action are presented. The implantation procedure is described in detail and illustrated with a series of intraoperative pictures. Finally, indications for SCS are discussed along with some of the controversies surrounding the therapy. Implications The reader is presented with a broad overview of spinal cord stimulation, including the historical and theoretical background, practical implantation technique, and clinical application.
High-frequency spinal cord stimulation for the treatment of chronic back pain patients: results of a prospective multicenter European clinical study. [2022]The objective of this prospective, open-label, multicenter European clinical trial was to quantify the efficacy and safety of a spinal cord stimulation (SCS) system that utilizes high-frequency (up to 10 kHz) waveforms, which do not produce paresthesia, for the treatment of chronic, intractable pain of the back and/or limbs.
Pulse width programming in spinal cord stimulation: a clinical study. [2019]With advances in spinal cord stimulation (SCS) technology, particularly rechargeable implantable, patients are now being offered a wider range of parameters to treat their pain. In particular, pulse width (PW) programming ranges of rechargeable implantable pulse generators now match that of radiofrequency systems (with programmability up to 1000 microseconds. The intent of the present study was to investigate the effects of varying PW in SCS.
Rate of Complications Following Spinal Cord Stimulation Paddle Electrode Removal. [2022]Spinal cord stimulation (SCS) is a safe, reversible surgical treatment for complex regional pain syndrome and failed back surgery syndrome refractory to conventional medical management. Paddle electrodes are routinely used for the permanent implant because of the reduced risk of migration, lower energy requirements, and expanded coverage options. The risks associated with paddle lead removal are not well defined in the literature.
First Report on Real-World Outcomes with Evoked Compound Action Potential (ECAP)-Controlled Closed-Loop Spinal Cord Stimulation for Treatment of Chronic Pain. [2023]A novel closed-loop spinal cord stimulation (SCS) system has recently been approved for use which records evoked compound action potentials (ECAPs) from the spinal cord and utilizes these recordings to automatically adjust the stimulation strength in real time. It automatically compensates for fluctuations in distance between the epidural leads and the spinal cord by maintaining the neural response (ECAP) at a determined target level. This data collection was principally designed to evaluate the performance of this first closed-loop SCS system in a 'real-world' setting under normal conditions of use in a single European center.
A Systematic Evaluation of Burst Spinal Cord Stimulation for Chronic Back and Limb Pain. [2022]Traditional tonic spinal cord stimulation (SCS) has been approved by FDA for chronic pain of intractable back and limb pain. However, it induces paresthesia and relieves pain poorly to some extent. Recently, burst SCS has been developed for pain reduction without the mandatory paresthesia.
Spinal cord stimulation: uses and applications. [2010]Spinal cord stimulation has been used successfully for more than 40 years. The application of an electrical impulse field on to the spinal cord is used with a battery generator source and a variety of either cylindrical or paddle/plate leads. Energy is delivered from either a conventional internal programmable generator or a rechargeable style battery. Many clinical conditions such as complex regional pain syndrome, failed back spinal syndrome, and extremity neuropathic pain involving the trunk and limbs are approved for its use. This device allows patients to live a successful life without pain.
Effects of Tonic Spinal Cord Stimulation on External Mechanical and Thermal Stimuli Perception Using Quantitative Sensory Testing: A Multicenter Stimulation ON-OFF Study on Chronic Pain Patients. [2021]Tonic spinal cord stimulation (SCS) is currently used to treat neuropathic pain. With this type of stimulation, an implantable pulse generator generates electrical paresthesias in the affected area through 1 or more epidural leads. The goal of this study was to evaluate the impact of tonic SCS on the sensory perception of chronic pain patients using quantitative sensory testing (QST).
Paddle versus cylindrical leads for percutaneous implantation in spinal cord stimulation for failed back surgery syndrome: a single-center trial. [2014]Spinal cord stimulation is an interventional treatment for chronic pain syndromes such as failed back surgery syndrome (FBSS), and it utilizes either cylindrical or paddle electrodes placed percutaneously into the epidural space. This prospective nonrandomized single-center study investigated the specific advantages and disadvantages of percutaneously implanted paddle and cylindrical leads in patients with FBSS.