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
N/A
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
This research aims to compare how well spinal cord stimulation (SCS) works using new time varying pulse (TVP) patterns versus the current standard time-invariant pulse (TIP) patterns in people with chronic or neuropathic pain. The study explores both paresthesia and paresthesia-free SCS therapies and evaluates how long the effects of these stimulation patterns last. Participants will be randomly assigned to receive either the standard TIP stimulation or the experimental TVP stimulation, which varies in intensity or rate. TIP stimulation uses fixed settings for amplitude, pulse width, and frequency, while TVP stimulation adjusts these parameters dynamically. The study includes a long-term follow-up phase to track therapy effectiveness over time using multiple pain assessments and data collected digitally at home. During the study, participants will be monitored through pain questionnaires and other assessments at baseline and during three experimental stimulation periods, each lasting approximately 8 weeks. Researchers will measure changes in patient responder rates compared to baseline to evaluate pain outcomes. The study involves device use, adherence tracking, and safety monitoring throughout. Participation lasts through these treatment and follow-up phases, allowing detailed observation of therapy effects.
CONDITIONS
Brief 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 lasting at least 6 months
- Baseline average daily pain score above 60 on a 0-100mm Visual Analog Scale for back and/or limb pain
- Failed at least 3 medically supervised treatments and tried more than 2 classes of pain medications
- Stable pain medication dose for at least 4 weeks before the trial
- No back surgery within 6 months prior to screening
- Average daily morphine use less than or equal to 200 mg in the 30 days before screening
- Baseline Oswestry Disability Index score between 40 and 80
- Psychologically and psychiatrically eligible for spinal cord stimulation within 180 days before baseline
- Able to read and complete questionnaires in English independently
- Female participants of childbearing potential agree to use contraception during the study
- Deemed a good candidate for spinal cord stimulation by the principal investigator and a certified pain management physician
- Willing to cooperate with study requirements
You will not qualify if you...
- Catastrophization with daily pain intensity of 100 on a 0-100mm scale during the 7 days before screening
- Pain caused by peripheral vascular disease
- Active cancer treatment in the past 6 months
- Involvement in disability litigation
- High surgical risk including allergy to titanium or silicone, systemic or local infection near surgery site
- Body mass index 45 or higher at screening
- Terminal illness with expected survival under 12 months
- Being immunocompromised
- Significant cognitive impairment affecting study participation
- Current or planned participation in other drug or device trials that affect study data
- Previous spinal cord stimulation trial or implant, or existing active implantable device
- Pregnant or planning pregnancy during the study
- Plans to receive massages or manipulations over leads or device area
- Medical condition requiring diathermy use
- Any injury or condition that surgery or implant may worsen or threaten safety
- Unable to operate study devices including biosensor and mobile app
- Substance abuse or dependency within 6 months before baseline visit
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 8±3 weeks for each of the three experimental stimulation periods
Participants receive a spinal cord stimulator device programmed to deliver either Time Invariant Pulse (TIP) or Time Variant Pulse (TVP) stimulation as part of a crossover study to compare these therapies.
1 baseline visit and multiple follow-up visits during each stimulation period
Duration - Duration following the treatment phases until study completion
Participants undergo long-term follow-up to evaluate therapy efficacy using multiple pain assessments and at-home digital data collection.
Ongoing at-home data collection with periodic assessments
Trial Site Locations
Total: 1 location
1
Baylor College of Medicine
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
A
Ashwin Viswanathan, MD
L
Luke Jan Gelvoligaya, MA
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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