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Novel Stimulation Patterns to Improve the Effectiveness of Spinal Cord Stimulation

RecruitingNot applicableNCT05968664
View the official record on ClinicalTrials.gov

Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.

This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.

Brief summary (from the registry)

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.

Study details

Official title
Novel Stimulation Patterns to Improve the Effectiveness of Spinal Cord Stimulation
Sponsor
Ashwin Viswanathan
Collaborators
National Institute of Neurological Disorders and Stroke (NINDS); Boston Scientific Corporation
Organization
Baylor College of Medicine
Start date
2024-08-01
Primary completion
2028-01
Sex
All
Age range
from 22 Years
Results posted
No results posted in this snapshot
Countries
United States
Total sites listed
1

Eligibility criteria

Show eligibility criteria (verbatim from the registry)
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 implant…

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT05968664