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

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. ^{1 2 3 4 5}

Is 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. ^{6 7 8 9 10}

How 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. ^{6 11 12 13 14}

Research Team

Ashwin Viswanathan, MD

Principal Investigator

Baylor College of Medicine

Eligibility 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

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

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

Treatment Details

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.

Participant Groups

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

Findings from Research

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]

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]

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]

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]

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 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 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]

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]

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]

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 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 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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Patient-interactive, computer-controlled neurological stimulation system: clinical efficacy in spinal cord stimulator adjustment. [2004]

2. New Zealand 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. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Spinal cord stimulation for chronic, intractable pain: superiority of "multi-channel" devices. [2021]

4. United States 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. [2023]

5. Switzerland 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. [2022]

6. Germany pubmed.ncbi.nlm.nih.gov

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

7. United States 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. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Pulse width programming in spinal cord stimulation: a clinical study. [2019]

9. United States pubmed.ncbi.nlm.nih.gov

Rate of Complications Following Spinal Cord Stimulation Paddle Electrode Removal. [2022]

10. New Zealand 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. [2023]

11. United States pubmed.ncbi.nlm.nih.gov

A Systematic Evaluation of Burst Spinal Cord Stimulation for Chronic Back and Limb Pain. [2022]

12. United States pubmed.ncbi.nlm.nih.gov

Spinal cord stimulation: uses and applications. [2010]

13. United States 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. [2021]

14. Germany 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. [2014]