Novel Stimulation Patterns to Improve the Effectiveness of Spinal Cord Stimulation

NCT ID
NCT05968664
Registry status
Recruiting
Study type
Interventional
Phase
Not applicable
Sponsor
Ashwin Viswanathan
Conditions
Chronic Pain, Neuropathic Pain, Pain, Neuropathic

Overview

ClinicalTrials.gov lists this study as Recruiting.

Enrollment: 43 participants (Estimated).

What is being studied

  • Device: Spinal Cord Stimulator

Who may be eligible

Ages
22 Years to no maximum
Sex
All
Healthy volunteers accepted
No

ClinicalTrials.gov lists the following 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 \>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

Study locations

1 study location is listed.

Recruiting site status is explicitly provided for 1 location; 1 is listed as Recruiting.

Countries: United States

  • Texas, United States: 1

Sample of listed locations

  • Baylor College of Medicine — Houston, Texas, 77030, United States — Recruiting

Study details

Start date
August 1, 2024
Primary completion date
January 1, 2028
Completion date
January 1, 2028
First posted
August 1, 2023
Collaborators
Boston Scientific Corporation, National Institute of Neurological Disorders and Stroke (NINDS)

Source and update information

Source
ClinicalTrials.gov
NCT ID
NCT05968664
Registry last updated
November 22, 2024
QualifiedStudies registry data refreshed
October 2, 2026
QualifiedStudies record fetched
October 2, 2026

View NCT05968664 on ClinicalTrials.gov

Trial information can change. Confirm current study details with the study team or the registry.

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