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NCT Number: NCT07659743

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).

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Key information

Conditions

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

Age range

22 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Sheng Li, MD, PhD

CONTACT

[email protected]

(713) 797-7125

Shengai Li, MS

CONTACT

[email protected]

713-797-7561

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Collaborators

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

Registry information

Official study title

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)

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Jun 22, 2026
Registry last updated
Jul 31, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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