Novel Stimulation Patterns to Improve the Effectiveness of Spinal Cord Stimulation

Study Overview
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Brief Summary
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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
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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.

Official Title
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Novel Stimulation Patterns to Improve the Effectiveness of Spinal Cord Stimulation

Conditions
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Chronic Pain, Pain, Neuropathic, Neuropathic Pain

Intervention / Treatment
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* Device: Spinal Cord Stimulator
* Device: Spinal Cord Stimulator


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 >6 on the Numerical Rating Scale collected with a 7-day pain diary related to pain of the trunk 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. No new pain medication will be added 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 Exclusion Criteria: Patient exhibits catastrophization based on physician evaluation (e.g., average overall daily pain intensity of 10 on a 0-10 numerical rating 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 Previous spinal cord stimulation trial/implant or is already implanted with an active implantable device(s) (e.g. drug pump, implantable pulse generator) A pregnant female or a female of childbearing potential planning to get pregnant during the course of the study Plan to receive any massage or manipulation directly over the leads or by the anticipated location of the IPG or treatments that involve sudden jerking motions of the torso at any Existing medical condition that is likely to require the use of diathermy Any injury or medical/psychological condition that might be significantly exacerbated by the implant surgery or the presence of an implantable stimulator or otherwise compromise subject safety Unable to operate the study devices including wrist-worn biosensor and mobile app Documented history of substance abuse or dependency in the 6 months prior to baseline

Ages Eligible for Study
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Minimum Age: 22 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Time Invariant Pulse(TIP) Stimulation<br>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. | Device: Spinal Cord Stimulator<br>* Spinal Cord Stimulator to deliver standard of care Time Invariant Pulse (TIP) stimulation.<br>|
| Experimental: Time Variant Pulse (TVP) Stimulation<br>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. | Device: Spinal Cord Stimulator<br>* Spinal Cord Stimulator modified to deliver Time Variant Pulse (TVP) stimulation.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Patient responder rate | 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. | Patient responder rate will be measured from the baseline and during three experimental stimulation periods which are 8±3 weeks each. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic pain, Spinal Cord Stimulation, Spinal cord, Neuropathy