Novel Stimulation Patterns to Improve the Effectiveness of Spinal Cord Stimulation
Chronic Pain, Pain, Neuropathic, Neuropathic Pain
About this trial
This is an interventional treatment trial for Chronic Pain focused on measuring Chronic pain, Spinal Cord Stimulation, Spinal cord, Neuropathy
Eligibility Criteria
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
Sites / Locations
- Baylor College of Medicine
Arms of the Study
Arm 1
Arm 2
Active Comparator
Experimental
Time Invariant Pulse(TIP) Stimulation
Time Variant Pulse (TVP) 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.
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.