Spinal Cord Stimulation for Chronic Pain

(DYNAMO Trial)

Overseen By Luke Jan Gelvoligaya, MA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Ashwin Viswanathan

Disqualifiers: Cancer, Obesity, Infection, Cognitive impairment, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 8±3 weeks

43 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores new ways to manage chronic pain in the back or limbs using spinal cord stimulation, a therapy that uses electrical pulses to ease pain. It compares the usual method of delivering these pulses to a new technique that alters the pulse patterns. Individuals with chronic pain for at least six months, who have not found success with other treatments, might be suitable candidates. The goal is to determine if the new method reduces pain more effectively than the standard treatment. As an unphased trial, this study allows patients to contribute to innovative research that could lead to more effective pain management solutions.

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 prior data suggests that this spinal cord stimulation technique is safe for chronic pain treatment?

Research has shown that the Boston Scientific WaveWriter Alpha Spinal Cord Stimulator is generally safe for managing chronic pain. The FDA approved this device for such use, indicating a strong safety record. Many studies support its safety and endorse its use.

Patients using spinal cord stimulators like the WaveWriter Alpha often tolerate them well. Side effects are rare but may include discomfort or mild pain at the implantation site. It is important to discuss any risks related to specific health conditions with a healthcare provider. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Boston Scientific WaveWriter Alpha Spinal Cord Stimulator for chronic pain because it introduces time variant pulse (TVP) stimulation, a novel approach in spinal cord stimulation. Unlike the standard time invariant pulse (TIP) stimulation, which delivers a fixed pattern, TVP can adjust its intensity or rate, offering a more tailored pain management experience. This flexibility might lead to better pain relief outcomes by adapting more closely to a patient's changing needs.

What evidence suggests that this trial's treatments could be effective for chronic pain?

Research has shown that spinal cord stimulation (SCS) can significantly reduce chronic pain. In one study, patients using Boston Scientific's WaveWriter Alpha device reported a nearly 6-point drop in pain levels over two years. This device sends electrical signals to block pain messages before they reach the brain. In this trial, participants will be assigned to different arms to test the effectiveness of various stimulation methods. The Time Invariant Pulse (TIP) Stimulation serves as the control arm, while the Time Variant Pulse (TVP) Stimulation is the experimental arm. Both methods demonstrated effectiveness in previous studies, suggesting that the WaveWriter Alpha is a strong option for managing chronic pain. ^{1 3 4 6 7}

Who Is on the Research Team?

Ashwin Viswanathan, MD

Principal Investigator

Baylor College of Medicine

Are You a Good Fit for This Trial?

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

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

My back pain moderately to severely affects my daily activities.

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

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Boston Scientific WaveWriter Alpha Spinal Cord Stimulator

Trial Overview 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.

How Is the Trial Designed?

Group I: Time Variant Pulse (TVP) Stimulation Experimental Treatment 1 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) Stimulation Active Control 1 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

Who Is Running the Clinical Trial?

Ashwin Viswanathan

Lead Sponsor

Trials

1

Recruited

40+

National Institute of Neurological Disorders and Stroke (NINDS)

Collaborator

Trials

1,403

Recruited

655,000+

Boston Scientific Corporation

Industry Sponsor

Trials

758

Recruited

867,000+

Michael F. Mahoney

Boston Scientific Corporation

Chief Executive Officer since 2016

MBA from Wake Forest University, BBA in Finance from the University of Iowa

Kenneth Stein

Boston Scientific Corporation

Chief Medical Officer since 2020

MD from Harvard Medical School, MMSc in Clinical Investigation from Harvard-MIT Division of Health Sciences and Technology

Published Research Related to This Trial

In a clinical trial involving 83 patients with chronic back pain, 88% reported significant pain relief after using a high-frequency spinal cord stimulation (SCS) system, with back pain scores dropping from an average of 8.4 to 2.7 after six months.

The high-frequency SCS system not only provided substantial pain relief without causing the tingling sensation (paresthesia) typical of traditional SCS but also improved patients' disability and sleep quality, confirming its safety and efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High-frequency spinal cord stimulation for the treatment of chronic back pain patients: results of a prospective multicenter European clinical study. Van Buyten, JP., Al-Kaisy, A., Smet, I., et al.[2022]

In a study of 68 patients who had spinal cord stimulation paddle electrodes removed, the most common reason for removal was loss of coverage or effect (75%), indicating that while SCS is effective, it may not always provide lasting relief.

Postoperative complications occurred in 11.75% of patients, with two major complications requiring reoperation, highlighting that while SCS removal is generally safe, it does carry some risks that patients should be aware of.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rate of Complications Following Spinal Cord Stimulation Paddle Electrode Removal. Maldonado-Naranjo, AL., Frizon, LA., Sabharwal, NC., et al.[2022]

A multicenter feasibility study is underway to evaluate the effectiveness of evoked compound action potential (ECAP)-controlled closed-loop spinal cord stimulation (CL-SCS) in up to 300 patients with chronic pain, focusing on real-world outcomes over a 24-month period.

This innovative approach continuously adjusts stimulation based on neurophysiological feedback, which may enhance treatment personalization and improve understanding of chronic pain mechanisms, potentially leading to better patient management strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Real World Clinical Utility of Neurophysiological Measurement Utilizing Closed-Loop Spinal Cord Stimulation in a Chronic Pain Population: The ECAP Study Protocol. Leitner, A., Hanson, E., Soliday, N., et al.[2023]

In a study of 62 patients with chronic pain, spinal cord stimulation provided at least 50% pain relief for many, with improvements in daily activities and reduced need for pain medications, demonstrating its efficacy as a treatment for intractable pain.

The use of multi-channel devices and the presence of stimulation paresthesias over the pain area were significant predictors of successful outcomes, highlighting the importance of device technology and patient-specific factors in achieving pain relief.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Spinal cord stimulation for chronic, intractable pain: superiority of "multi-channel" devices. North, RB., Ewend, MG., Lawton, MT., et al.[2021]

Burst spinal cord stimulation (SCS) may provide better short-term pain relief for chronic back and limb pain compared to traditional tonic SCS, without causing the uncomfortable side effect of paresthesia, based on a systematic review of five studies involving 117 patients.

The current evidence for burst SCS is considered fair and limited, highlighting the need for more high-quality research with larger sample sizes to better understand its efficacy and safety in treating chronic pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Systematic Evaluation of Burst Spinal Cord Stimulation for Chronic Back and Limb Pain. Hou, S., Kemp, K., Grabois, M.[2022]

Spinal cord stimulation (SCS) is an effective surgical treatment for chronic neuropathic pain, with success rates ranging from 50-75% when performed by experienced practitioners, and is indicated for conditions like complex regional pain syndrome and diabetic neuropathy.

The procedure involves implanting leads in the spinal canal to deliver electrical currents, but it carries risks such as lead migration and infection, and its exact mechanisms of action remain only partially understood.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Spinal cord stimulation: Background and clinical application. Meier, K.[2022]

In a study of 48 chronic pain patients using tonic spinal cord stimulation (SCS), it was found that SCS reduced touch sensitivity in the area of the body where stimulation was applied, indicating some effect on sensory perception.

However, the overall impact of SCS on sensory perception was minimal, and the changes observed were not deemed clinically significant, suggesting that SCS may not substantially alter patients' daily experiences of pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Bordeleau, M., Carrondo Cottin, S., Cantin, L., et al.[2021]

Spinal cord stimulation has been effectively used for over 40 years to manage chronic pain conditions, including complex regional pain syndrome and failed back spinal syndrome.

The device works by delivering electrical impulses to the spinal cord, helping patients achieve pain relief and improve their quality of life, using either conventional or rechargeable battery systems.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Spinal cord stimulation: uses and applications. Golovac, S.[2010]

In a study involving 27 participants with chronic neuropathic low back pain, a novel paresthesia-free spinal cord stimulation (SCS) waveform significantly reduced pain levels, with a mean decrease of 51.7 mm on the visual analog scale at 26 weeks, and 76.9% of participants experiencing at least a 50% reduction in pain.

The treatment was found to be safe, with no unexpected adverse events reported, and all participants expressed satisfaction with their treatment, indicating that this new SCS waveform could be a promising option for managing chronic pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Russo, MA., Volschenk, W., Bailey, D., et al.[2023]

In a study involving patients with chronic low back and leg pain using spinal cord stimulation (SCS), varying the pulse width (PW) settings led to significant improvements in paresthesia-pain overlap for some patients, with an average increase of 56%.

The findings suggest that patients can benefit from personalized PW programming, as 7 out of 19 patients chose new settings that enhanced their pain relief experience, indicating that PW adjustments can effectively 'steer' paresthesia coverage.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pulse width programming in spinal cord stimulation: a clinical study. Yearwood, TL., Hershey, B., Bradley, K., et al.[2019]

The novel closed-loop spinal cord stimulation (SCS) system effectively reduced pain intensity in patients with chronic pain, showing significant decreases from a baseline score of 8.4 to 2.0 after 12 months, with 85% patient satisfaction reported.

This real-world study involving 22 patients supports the efficacy of the ECAP-controlled SCS system, maintaining pain relief comparable to results from previous clinical trials, indicating its potential as a reliable treatment option for persistent spinal pain syndrome.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

First Report on Real-World Outcomes with Evoked Compound Action Potential (ECAP)-Controlled Closed-Loop Spinal Cord Stimulation for Treatment of Chronic Pain. Nijhuis, HJA., Hofsté, WJ., Krabbenbos, IP., et al.[2023]

Spinal cord stimulation has become a low-morbidity technique for managing chronic pain, with recent advancements allowing for easier implantation and adjustment of the system in patients.

A new computerized system for patient interaction has been clinically tested in 25 patients, proving to be safe and effective, and allows for quicker adjustments to the stimulator compared to traditional methods, enhancing the overall management of pain relief.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient-interactive, computer-controlled neurological stimulation system: clinical efficacy in spinal cord stimulator adjustment. North, RB., Fowler, K., Nigrin, DJ., et al.[2004]

In a study of 100 patients with failed back surgery syndrome, both paddle and cylindrical spinal cord stimulation leads provided similar significant pain relief, reducing pain by about 69%.

However, the cylindrical leads had higher rates of dislocation (14%) and infection (10%) compared to paddle leads, which had lower rates of 6% and 2%, respectively, suggesting paddle leads may be a safer option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Paddle versus cylindrical leads for percutaneous implantation in spinal cord stimulation for failed back surgery syndrome: a single-center trial. Kinfe, TM., Quack, F., Wille, C., et al.[2014]

A study of patients with chronic neuropathic pain who experienced loss of efficacy from spinal cord stimulation (SCS) showed significant improvements in pain intensity and quality of life after using new stimulation waveforms through implanted pulse generator adapters.

After 12 months, 81.3% of patients preferred the tonic stimulation option, indicating that these adapters could be an effective salvage solution for managing patients with decreased SCS effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Rigoard, P., Ounajim, A., Goudman, L., et al.[2022]

Citations

1. bostonscientific.com bostonscientific.com/en-US/medical-specialties/pain-management/scs-clinical-data.html

Spinal Cord Stimulation (SCS) Clinical Data Long-Term Chronic Pain-Relief Outcomes Using an SCS System Capable of Combination Therapy (WaveWriter Outcomes Study] [Abstract]. Twenty-fifth Annual ...

2. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf3/P030017S363B.pdf

FDA - Summary of Safety and Effectiveness Data (SSED) The Boston Scientific Spectra WaveWriter™, WaveWriter Alpha™ and WaveWriter. Alpha™ Prime SCS Systems are also indicated as an aid in the management of chronic.

3. bostonscientific.com bostonscientific.com/us/en/healthcare-professionals/products/spinal-cord-stimulator-scs-systems/wavewriter-alpha-spinal-cord-stimulator-system/fp00000267.html

WaveWriter Alpha™ Spinal Cord Stimulator System The WaveWriter Alpha SCS System is a complete solution tailored to meet you and your patients' needs at every point in the pain management journey.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10889739/

Improved Outcomes and Therapy Longevity after Salvage ... Our results suggest that patients who experience LoE over time may benefit from upgrading to a more versatile SCS system.

5. pain.com pain.com/en/chronic-pain-solutions/spinal-cord-stimulation/spectra-wavewriter.html

Spectra WaveWriter Spinal Cord Stimulator (SCS) System Lasting results. Boston Scientific SCS patients reported a nearly 6-point drop in pain score, even after two years.2.

6. bostonscientific.com bostonscientific.com/en-US/medical-specialties/pain-management/wavewriter-alpha-scs.html

WaveWriter Alpha SCS System The WaveWriter Alpha™ SCS System provides safe access to full-body MRI scans when used with specific components and the patient is exposed to the MRI ...

7. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf3/P030017S357B.pdf

FDA - Summary of Safety and Effectiveness Data (SSED) The following patients are contraindicated from being treated with Boston Scientific. Spinal Cord Stimulator Systems: • Poor surgical candidates;. • Unable to ...