Novel Stimulation Patterns to Improve the Effectiveness of Spinal Cord Stimulation

NCT05968664 | Recruiting DMC FDA Device

• 2 other identifiers: H-494054UH3NS121563-02
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

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

Keywords

Chronic pain; Spinal Cord Stimulation; Spinal cord; Neuropathy

Outcome Measures

Primary Outcomes (1)

• Change in Patient responder rate

  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.

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

Study Arms (2)

Time Invariant Pulse(TIP) Stimulation

ACTIVE COMPARATOR

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.

Device: Spinal Cord Stimulator

Time Variant Pulse (TVP) Stimulation

EXPERIMENTAL

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.

Device: Spinal Cord Stimulator

Interventions

Spinal Cord Stimulator DEVICE

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

Time Variant Pulse (TVP) Stimulation

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ashwin Viswanathan: lead
• National Institute of Neurological Disorders and Stroke (NINDS): collaborator
• Boston Scientific Corporation: collaborator

Study Sites (1)

Baylor College of Medicine

Houston, Texas, 77030, United States

RECRUITING

MeSH Terms

Conditions

Chronic Pain; Neuralgia

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases

Study Officials

• Ashwin Viswanathan, MD

  Baylor College of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ashwin Viswanathan, MD

CONTACT

7132138181; ashwinv@bcm.edu

Luke Jan Gelvoligaya, MA

CONTACT

7137987245; lukejan.gelvoligaya@bcm.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 7, 2023
• First Posted: August 1, 2023
• Study Start: August 1, 2024
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2028
• Last Updated: November 22, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE

Locations

US (1)