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Spinal Cord Stimulation for Chronic Pain

This study is testing new ways to use Spinal Cord Stimulators (SCS), devices that send mild electrical pulses to your spinal cord to block pain signals. Researchers want to see if a modified SCS, delivering "Time Variant Pulse (TVP)" stimulation, works better for chronic pain than the standard "Time Invariant Pulse (TIP)" stimulation. You might be able to join if you are at least 22 years old, have chronic pain in your body or limbs for at least 6 months, and your pain score is consistently above 60 out of 100. The study will measure how many patients respond positively to the different stimulation patterns. The current recruitment status is unclear.

Study design
This is an interventional study comparing two types of Spinal Cord Stimulator settings in about 43 participants. It will explore the effectiveness of time-varying versus standard stimulation patterns.
What's involved
You would undergo three experimental stimulation periods, each lasting about 8 weeks. Throughout the study, your pain will be assessed multiple times, and digital data will be collected at home.
Compensation
Not stated in the trial record.
Follow-up
The study will track how well the therapy works through a long-term follow-up phase, but the exact duration is not specified.

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NCT05968664

Novel Stimulation Patterns to Improve the Effectiveness of Spinal Cord Stimulation

Recruiting
NAAges 22+InterventionalTreatment
Ashwin Viswanathan
~43 participants
Updated 2024-11-22 on ClinicalTrials.gov
What's tested:Spinal Cord Stimulator

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in Patient responder rate
Measured over Patient responder rate will be measured from the baseline and during three experimental stimulation periods which are 8±3 weeks each.

Conditions

Chronic Pain
Pain, Neuropathic
Neuropathic Pain

Explore related trials

Chronic PainNeuropathic Pain

Where it's being run

1 sites across 1 states
Texas1

Study leadership

  • Ashwin Viswanathan, MD · PRINCIPAL_INVESTIGATOR · Baylor College of Medicine

Who to contact

Ashwin Viswanathan, MD
[email protected]
7132138181
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Change in Patient responder ratePatient responder rate will be measured from the baseline and during three experimental stimulation periods which are 8±3 weeks each.

    The primary endpoint for this trial will be a comparison of the percentage of patients achieving at least a 50% reduction in pain during the TIP stimulation block with the percentage of patients achieving at least a 50% reduction in pain during either TVP stimulation block.