Novel Stimulation Patterns to Improve the Effectiveness of Spinal Cord Stimulation
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Chronic Pain
- Sponsor
- Ashwin Viswanathan
- Enrollment
- 43
- Locations
- 1
- Primary Endpoint
- Change in Patient responder rate
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief 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.
Detailed Description
The researchers will conduct a traditional exploratory feasibility study using an investigational device to compare the clinical outcomes using time varying pulse (TVP) waveforms against time-invariant pulse (TIP) waveforms using both paresthesia and paresthesia-free SCS therapies. The therapy longevity of TVPs and TIPS will also be evaluated by tracking therapy efficacy through a long-term follow-up phase, using multiple pain assessments and at-home digital data collection.
Investigators
Ashwin Viswanathan
Professor
Baylor College of Medicine
Eligibility Criteria
Inclusion Criteria
- •Ability to provide informed consent
- •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
Exclusion Criteria
- •Patient exhibits catastrophization based on physician evaluation (e.g., average overall daily pain intensity of 100 on a 0-100mm visual analog scale, every day during the 7 days prior to Screening, based on patient recall
- •Pain originating from peripheral vascular disease
- •Active treatment for cancer in past 6 months
- •Involved in disability litigation
- •High surgical risk including documented history of allergic response to titanium or silicone, current systemic infection, or local infection in close proximity to anticipated surgical field
- •Body mass index ≥ 45 at Screening
- •Terminal illness with anticipated survival \< 12 months
- •Participant is immunocompromised
- •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
- •Participating (or intends to participate) in another drug or device clinical trial that may influence the data that will be collected for this study
Outcomes
Primary Outcomes
Change in Patient responder rate
Time Frame: Patient responder rate will be measured from the baseline and during three experimental stimulation periods which are 8±3 weeks each.
The primary endpoint for this trial will be a comparison of the percentage of patients achieving at least a 50% reduction in pain during the TIP stimulation block with the percentage of patients achieving at least a 50% reduction in pain during either TVP stimulation block.