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

NCT07659743 | Not Yet Recruiting DMC FDA Device

• 2 other identifiers: HSC-MS-26-0102UG3NS139014
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

neuropathic pain; BreEStim

Outcome Measures

Primary Outcomes (1)

• Change in Pain Level as Measured by the Visual Analog Scale (VAS).

  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 Outcomes (2)

• the difference in the percentage of responders between active BreEStim and Sham BreEStim groups

  Baseline, 10-15 minutes after intervention

• the difference in the percentage of responders between between active BreEStim and transcutaneous electrical nerve stimulation (TENS) groups.

  Baseline, 10-15 minutes after intervention

Study Arms (3)

Active BreEStim Treatment

EXPERIMENTAL

Device: Active BreEStim Treatment

Sham BreEStim Treatment

SHAM COMPARATOR

Device: Sham BreEStim Treatment

The transcutaneous electrical nerve stimulation (TENS) Treatment

ACTIVE COMPARATOR

Device: The TENS Treatment

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.

Active BreEStim Treatment

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.

Sham BreEStim Treatment

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.

The transcutaneous electrical nerve stimulation (TENS) Treatment

Eligibility Criteria

• Age: 22 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead
• National Institutes of Health (NIH): collaborator
• National Institute of Neurological Disorders and Stroke (NINDS): collaborator

Study Sites (1)

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Agnosia; Neuralgia

Condition Hierarchy (Ancestors)

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

Study Officials

• Sheng Li, MD, PhD

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sheng Li, MD, PhD

CONTACT

(713) 797-7125; sheng.li@uth.tmc.edu

Shengai Li, MS

CONTACT

713-797-7561; shengai.li@uth.tmc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 15, 2026
• First Posted: June 22, 2026
• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): July 31, 2029
• Study Completion (Estimated): September 30, 2029
• Last Updated: July 31, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)