Improving spinal cord stimulation for chronic pain relief

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to evaluate the effectiveness of spinal cord stimulation (SCS) using novel time varying pulse (TVP) waveforms compared to standard time-invariant pulse (TIP) waveforms. Participants with chronic pain will be monitored for pain outcomes and therapy longevity through a combination of clinical assessments and at-home digital data collection. The study will include both paresthesia and paresthesia-free SCS therapies to determine which method provides better pain relief. Long-term follow-up will track the efficacy of the different stimulation patterns.

Why it matters

Who can join: the full rules

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 \>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
* 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 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
* 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

Where it's running

• Baylor College of Medicine
  Houston, Texas, United States Recruiting

Study contacts

• Principal investigator: Ashwin Viswanathan, MD — Baylor College of Medicine
• Study coordinator: Ashwin Viswanathan, MD
• Email: ashwinv@bcm.edu
• Phone: 7132138181

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.