Novel Stimulation Patterns to Improve the Effectiveness of Spinal Cord Stimulation

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 22
Healthy Volunteers: f
View:

• Ability to provide informed consent

• Age ≥ 22

• Chronic pain of the trunk and/or limbs for at least 6 months

• Baseline average daily overall pain score of \>60 (on a scale of 0-100mm) on the Visual Analog Scale related to pain of the back and/or limbs

• Failed ≥3 medically supervised treatments (i.e. pain medications, physical therapy, facet joint/medial branch nerve blocks, acupuncture), and treatment with \>2 classes of medications

• Stable pain-related medication regimen 4 weeks prior to the trial. Patients will be asked to not increase or add pain-related medication during the study period

• No back surgery within 6 months prior to Screening

• Consumed an average total daily morphine equivalent of ≤200 mg during the 30 days prior to Screening.

• Baseline Oswestry Disability Index score ≥40 and ≤80

• 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

• Female candidates of child-bearing potential agree to use contraception during the study period

• Deemed to be a good candidate for spinal cord stimulation by the PI, and a board certified pain management physician

• Willing to cooperate with study requirements

Locations
United States
Texas
Baylor College of Medicine
RECRUITING
Houston
Contact Information
Primary
Ashwin Viswanathan, MD
ashwinv@bcm.edu
7132138181
Backup
Luke Jan Gelvoligaya, MA
lukejan.gelvoligaya@bcm.edu
7137987245
Time Frame
Start Date: 2024-08-01
Estimated Completion Date: 2028-01
Participants
Target number of participants: 43
Treatments
Active_comparator: Time Invariant Pulse(TIP) Stimulation
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.
Experimental: Time Variant Pulse (TVP) Stimulation
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.
Related Therapeutic Areas
Sponsors
Collaborators: Boston Scientific Corporation, National Institute of Neurological Disorders and Stroke (NINDS)
Leads: Ashwin Viswanathan

This content was sourced from clinicaltrials.gov