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

Part of paid clinical trials in Houston, Texas.

Sponsor
The University of Texas Health Science Center, Houston
Study ID
NCT07659743
Status
Not Yet Recruiting

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Conditions

  • Pain Management

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Active BreEStim Treatment — DEVICE
    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 BreEStim Treatment — DEVICE
    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.
  • The TENS Treatment — DEVICE
    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.

Study Details

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).

Key Dates

Start date
Oct 1, 2026
Status verified
Jun 2026
Primary completion
Jul 31, 2029
Completion
Sep 30, 2029

Study Design

Enrollment
66 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Active BreEStim Treatment
  • Sham Comparator: Sham BreEStim Treatment
  • Active Comparator: The transcutaneous electrical nerve stimulation (TENS) Treatment

Primary Outcome Measure

Change in Pain Level as Measured by the Visual Analog Scale (VAS). [ Time Frame: Baseline, 10-15 minutes after intervention ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
The University of Texas Health Science Center at HoustonHoustonTexas77030
Sheng Li, MD, PhD
[email protected]
713-797-7125
Shengai Li
[email protected]
713-797-7561

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By research site
The University of Texas Health Science Center at Houston· Houston, TX

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