Recruiting

Spinal Cord StimulationNovel Stimulation Patterns to Improve the Effectiveness of Spinal Cord Stimulation

Sponsor:

Ashwin Viswanathan

Code:

NCT05968664

Conditions

Chronic Pain

Pain, Neuropathic

Neuropathic Pain

Eligibility Criteria

Sex: All

Age: 22+

Healthy Volunteers: Not accepted

Interventions

Spinal Cord Stimulator

Study Details

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.

Conditions

Chronic Pain

Pain, Neuropathic

Neuropathic Pain

Study ID

NCT05968664

Start date

Aug 1, 2024

Status verified date

Jun, 2024

Completion date

Jan, 2028

Anticipated

Primary completion date

Jan, 2028

Anticipated

Eligibility Criteria

Sex: All

Age: 22+

Healthy Volunteers: Not accepted

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 Design

Enrollment

43 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Time Invariant Pulse(TIP) 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.

experimental: Time Variant Pulse (TVP) Stimulation

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.

Interventions

Spinal Cord Stimulator

Spinal Cord Stimulator modified to deliver Time Variant Pulse (TVP) stimulation.

Spinal Cord Stimulator

Spinal Cord Stimulator to deliver standard of care Time Invariant Pulse (TIP) stimulation.

Primary outcome measure

Change in Patient responder rate [ Time Frame: Patient responder rate will be measured from the baseline and during three experimental stimulation periods which are 8±3 weeks each. ]

Central Contacts and Locations

Central contacts

Ashwin Viswanathan, MD

7132138181 ashwinv@bcm.edu

Luke Jan Gelvoligaya, MA

7137987245 lukejan.gelvoligaya@bcm.edu

Locations

Baylor College of Medicine

Recruiting

Houston, Texas, United States, 77030

More Information

Sponsor

Ashwin Viswanathan

Last update posted

Nov 22, 2024

Last verified

Jun, 2024

Keywords

Chronic pain
Spinal Cord Stimulation
Spinal cord
Neuropathy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Ashwin Viswanathan on 2024-11-22.