Actively Recruiting
Novel Stimulation Patterns to Improve the Effectiveness of Spinal Cord Stimulation
Led by Ashwin Viswanathan · Updated on 2024-11-22
43
Participants Needed
1
Research Sites
178 weeks
Total Duration
On this page
Sponsors
A
Ashwin Viswanathan
Lead Sponsor
N
National Institute of Neurological Disorders and Stroke (NINDS)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Novel Stimulation Patterns to Improve the Effectiveness of Spinal Cord Stimulation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Ability to provide informed consent
- Age 22 years or older
- Chronic pain of the trunk and/or limbs for at least 6 months
- Baseline average daily overall pain score over 60 on a 0-100mm Visual Analog Scale related to back and/or limb pain
- Failure of at least 3 medically supervised treatments and treatment with more than 2 classes of medications
- Stable pain medication regimen for 4 weeks prior to the trial without increases or additions during the study
- No back surgery within 6 months prior to screening
- Consumed average daily morphine equivalent of 200 mg or less during 30 days prior to screening
- Baseline Oswestry Disability Index score between 40 and 80
- Psychologically and psychiatrically eligible for spinal cord stimulation within 180 days prior to baseline
- Able to independently read and complete all questionnaires and assessments in English
- Female candidates of child-bearing potential agree to use contraception during the study
- Considered a good candidate for spinal cord stimulation by the principal investigator and a board certified pain management physician
- Willing to cooperate with study requirements
You will not qualify if you...
- Catastrophization with daily average pain intensity of 100 on a 0-100mm scale during 7 days prior to screening
- Pain caused by peripheral vascular disease
- Active cancer treatment within past 6 months
- Involvement in disability litigation
- High surgical risk including allergy to titanium or silicone, current systemic or local infection near surgical site
- Body mass index 45 or greater at screening
- Terminal illness with life expectancy under 12 months
- Immunocompromised status
- Significant cognitive impairment affecting study participation
- Participation in another drug or device clinical trial that may affect study data
- Previous spinal cord stimulation trial or implant, or implanted active implantable device
- Pregnant female or planning pregnancy during study
- Plan to receive massage or manipulation over leads or implant site, or treatments causing sudden jerking of torso
- Medical condition requiring diathermy
- Any injury or medical/psychological condition that may worsen with implant surgery or presence of stimulator
- Inability to operate study devices including biosensor and mobile app
- History of substance abuse or dependency within 6 months prior to baseline
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Baylor College of Medicine
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
A
Ashwin Viswanathan, MD
CONTACT
L
Luke Jan Gelvoligaya, MA
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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