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

June 18, 2026 updated by: Sheng Li, The University of Texas Health Science Center, Houston

A Randomized, Double-blind, Sham-controlled, Parallel-group Trial Designed to Evaluate the Efficacy of BreEStim in Managing Neuropathic Pain After Spinal Cord Injury (SCI)

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).

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

66

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • has a history of SCI > 1 year
  • has a DN4 (Douleur Neuropathique en 4 Questions) score of 4 or greater
  • has neuropathic pain >3 months
  • is stable on oral pain medications at least one month
  • Able to tolerate BreEStim treatment for 1 minute

Exclusion Criteria:

  • is on a mechanical ventilator
  • is currently having active urinary tract infection (UTI)
  • does not have any residual sensation in the arms
  • has other pain (musculoskeletal, visceral etc.), but not neuropathic, e.g., shoulder pain from wheelchair use
  • has a pacemaker to avoid possible side effect of electrical stimulation
  • is not able to follow commands, or to give consent
  • has asthma or other pulmonary disease
  • has a history of cardiac pathology, implanted pacemakers, or current use of rhythm altering medication like beta-blockers
  • has baclofen pump or deep brain implants
  • has respiratory tract/sinus infection and rhinorrhea
  • has low motor neuron injury that no responses will be triggered by electrical stimulation
  • has severe mental disorders (e.g., depression, substance abuse) and is receiving active treatment and frequent monitoring
  • is not medically stable

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Active BreEStim Treatment
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.
Sham Comparator: Sham BreEStim Treatment
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.
Active Comparator: The transcutaneous electrical nerve stimulation (TENS) Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Pain Level as Measured by the Visual Analog Scale (VAS).
Time Frame: Baseline, 10-15 minutes after intervention
VAS scores are recorded from 0 to 10 with 0 being "no pain" and 10 being "worst pain", a higher score indicating a higher level of pain. Change is reported as [(VAS score at baseline) - (VAS Score 10 minutes after intervention)] - a positive value indicates that the score (and pain level) decreased. Mean VAS difference will be compared.
Baseline, 10-15 minutes after intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the difference in the percentage of responders between active BreEStim and Sham BreEStim groups
Time Frame: Baseline, 10-15 minutes after intervention
Given sham-controlled design, the investigators define responders as individual participants who achieve at least a 30% reduction in pain from their individual baseline scores.
Baseline, 10-15 minutes after intervention
the difference in the percentage of responders between between active BreEStim and transcutaneous electrical nerve stimulation (TENS) groups.
Time Frame: Baseline, 10-15 minutes after intervention
Given sham-controlled design, the investigators define responders as individual participants who achieve at least a 30% reduction in pain from their individual baseline scores.
Baseline, 10-15 minutes after intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Texas Health Science Center, Houston

Collaborators

National Institute of Neurological Disorders and Stroke (NINDS)
National Institutes of Health (NIH)

Investigators

  • Principal Investigator: Sheng Li, MD, PhD, The University of Texas Health Science Center, Houston

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 1, 2026

Primary Completion (Estimated)

July 31, 2029

Study Completion (Estimated)

September 30, 2029

Study Registration Dates

First Submitted

June 15, 2026

First Submitted That Met QC Criteria

June 15, 2026

First Posted (Actual)

June 22, 2026

Study Record Updates

Last Update Posted (Actual)

June 23, 2026

Last Update Submitted That Met QC Criteria

June 18, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HSC-MS-26-0102
  • UG3NS139014 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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