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Novel Stimulation Patterns to Improve the Effectiveness of Spinal Cord Stimulation

NCT05968664 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 43

Last updated 2024-11-22

No results posted yet for this study

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

Interventions

DEVICE

Spinal Cord Stimulator

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

DEVICE

Spinal Cord Stimulator

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

Sponsors & Collaborators

  • National Institute of Neurological Disorders and Stroke (NINDS)

    collaborator NIH

  • Boston Scientific Corporation

    collaborator INDUSTRY

  • Ashwin Viswanathan

    lead OTHER

Principal Investigators

  • Ashwin Viswanathan, MD · Baylor College of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
22 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-08-01
Primary Completion
2028-01-31
Completion
2028-01-31
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05968664 on ClinicalTrials.gov