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BreEStim in Managing Neuropathic Pain After Spinal Cord Injury (SCI)

NCT07659743 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 66

Last updated 2026-07-31

No results posted yet for this study

Summary

The purpose of this study is to compare the effectiveness of innovative intervention of breathing controlled electrical stimulation (BreEStim) and sham BreEStim and Transcutaneous Electrical Nerve Stimulation (TENS) in management of neuropathic pain in patients after spinal cord injury (SCI).

Conditions

  • Pain Management

Interventions

DEVICE

Active BreEStim Treatment

During the Active BreEStim Treatment session, participants will remain relaxed while breathing is monitored using a nasal cannula. Surface electrodes will be placed over the median nerve at the wrist or another selected peripheral nerve. Electrical stimulation will be synchronized with voluntary breathing and delivered at an individually tolerated intensity for approximately 30 minutes.

DEVICE

Sham BreEStim Treatment

During the Sham BreEStim Treatment session, participants will remain relaxed while breathing is monitored using a nasal cannula. Surface electrodes will be placed over the median nerve at the wrist or another selected peripheral nerve. Electrical stimulation will be synchronized with voluntary breathing and delivered at the sensory threshold level for approximately 30 minutes.

DEVICE

The TENS Treatment

During the TENS Treatment session, participants will remain relaxed while transcutaneous electrical stimulation is applied through surface electrodes placed over the painful area. Stimulation will be delivered at an individually tolerated intensity for approximately 30 minutes.

Sponsors & Collaborators

  • National Institutes of Health (NIH)

    collaborator NIH

  • National Institute of Neurological Disorders and Stroke (NINDS)

    collaborator NIH

  • The University of Texas Health Science Center, Houston

    lead OTHER

Principal Investigators

  • Sheng Li, MD, PhD · The University of Texas Health Science Center, Houston

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
22 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-10-01
Primary Completion
2029-07-31
Completion
2029-09-30
FDA Device
Yes

Countries

  • United States

Study Locations

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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 NCT07659743 on ClinicalTrials.gov