43 Participants Needed

Spinal Cord Stimulation for Chronic Pain

(DYNAMO Trial)

AV
LJ
Overseen ByLuke Jan Gelvoligaya, MA
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Ashwin Viswanathan
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 1 JurisdictionThis treatment is already approved in other countries

What You Need to Know Before You Apply

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.

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.12345

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.16789

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.1011121314

Who Is on the Research Team?

Ashwin Viswanathan (@drashwinv) / X

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

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
See 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
See 14 more

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?
2Treatment groups
Experimental Treatment
Active Control
Group I: Time Variant Pulse (TVP) StimulationExperimental Treatment1 Intervention
Group II: Time Invariant Pulse(TIP) StimulationActive Control1 Intervention

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:

Find a Clinic Near You

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 profile image

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 profile image

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

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

Citations

Patient-interactive, computer-controlled neurological stimulation system: clinical efficacy in spinal cord stimulator adjustment. [2004]
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 for chronic, intractable pain: superiority of "multi-channel" devices. [2021]
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 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]
Spinal cord stimulation: Background and clinical application. [2022]
High-frequency spinal cord stimulation for the treatment of chronic back pain patients: results of a prospective multicenter European clinical study. [2022]
Pulse width programming in spinal cord stimulation: a clinical study. [2019]
Rate of Complications Following Spinal Cord Stimulation Paddle Electrode Removal. [2022]
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 Statespubmed.ncbi.nlm.nih.gov
A Systematic Evaluation of Burst Spinal Cord Stimulation for Chronic Back and Limb Pain. [2022]
12.United Statespubmed.ncbi.nlm.nih.gov
Spinal cord stimulation: uses and applications. [2010]
13.United Statespubmed.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]
Paddle versus cylindrical leads for percutaneous implantation in spinal cord stimulation for failed back surgery syndrome: a single-center trial. [2014]
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