NCT05968664 Novel Stimulation Patterns to Improve the Effectiveness of Spinal Cord Stimulation
| NCT ID | NCT05968664 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Ashwin Viswanathan |
| Condition | Chronic Pain |
| Study Type | INTERVENTIONAL |
| Enrollment | 43 participants |
| Start Date | 2024-08-01 |
| Primary Completion | 2028-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 43 participants in total. It began in 2024-08-01 with a primary completion date of 2028-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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
Contact & Investigator
Ashwin Viswanathan, MD
PRINCIPAL INVESTIGATOR
Baylor College of Medicine
Frequently Asked Questions
Who can join the NCT05968664 clinical trial?
This trial is open to participants of all sexes, aged 22 Years or older, studying Chronic Pain. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05968664 currently recruiting?
Yes, NCT05968664 is actively recruiting participants. Contact the research team at ashwinv@bcm.edu for enrollment information.
Where is the NCT05968664 trial being conducted?
This trial is being conducted at Houston, United States.
Who is sponsoring the NCT05968664 clinical trial?
NCT05968664 is sponsored by Ashwin Viswanathan. The principal investigator is Ashwin Viswanathan, MD at Baylor College of Medicine. The trial plans to enroll 43 participants.
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