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Not yet recruitingNCT07878429Updated Oct 20, 2026

BreEStim Pre-trial

An interventional study of Single-pulse BreEStim Treatment and Multiple-pulse BreEStim Treatment in Neuropathic Pain, sponsored by The University of Texas Health Science Center, Houston. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-20.

Sponsored by The University of Texas Health Science Center, Houston · Not applicable, Interventional, and Treatment

Updated Oct 16, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
32
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study summary

The overall goal is to evaluate the effectiveness of different stimulation protocol of a novel intervention - Breathing-controlled electrical stimulation (BreEStim) in managing neuropathic pain after spinal cord injury (SCI).

02

Conditions studied

  • Neuropathic Pain

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Keywords

  • BreEStim
  • neuropathic pain
03

In context

Neuralgia

1,303 studies on the registry are indexed under Neuralgia; 261 are open to participants now.

This study's planned enrollment of 32 is below the median of 52 across 986 interventional studies indexed under Neuralgia.

Browse Neuralgia studies →

Lead sponsor

The University of Texas Health Science Center, Houston is the lead sponsor of 897 studies on the registry; 214 are open to participants now.

Of its 173 completed or terminated interventional studies of FDA-regulated products, 142 (82%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility criteria

Inclusion Criteria (SCI subjects):

  • has a history of SCI > 1 year;
  • has a DN4 (Douleur Neuropathique en 4 questions)* score of 4 or greater;
  • has an average pain score of 4 or more
  • has neuropathic pain >3 months;
  • is between 22 to 80 years of age;
  • is stable on oral pain medications at least one month (no change in frequency and dosing of pain medications);
  • is able to tolerate BreEStim treatment for 1 minute.

Exclusion Criteria (SCI subjects):

  • 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 a baclofen pump or deep brain implants;
  • has a 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.
  • Pregnancy

Inclusion criteria (healthy subjects):

  • healthy;
  • between 18-75 years old.

Exclusion criteria (healthy subjects):

  • individuals with neuromusculoskeletal impairments/injury or pain;
  • women who are pregnant
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
32 participants (estimated)

Study arms

  • Experimental
    Single-pulse BreEStim Treatment, Then Multiple-pulse BreEStim Treatment

    Device: Single-pulse BreEStim Treatment · Device: Multiple-pulse BreEStim Treatment

  • Experimental
    Multiple-pulse BreEStim Treatment, Then Single-pulse BreEStim Treatment

    Device: Single-pulse BreEStim Treatment · Device: Multiple-pulse BreEStim Treatment

Interventions

  • DeviceSingle-pulse BreEStim Treatment

    During the Single-pulse 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. A single-pulse electrical stimulation will be synchronized with voluntary breathing and delivered at an individually tolerated intensity for approximately 30 minutes.

  • DeviceMultiple-pulse BreEStim Treatment

    During the Multiple-pulse 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. Multiple-pulse electrical stimulation will be synchronized with voluntary breathing and delivered at an individually tolerated intensity for approximately 30 minutes.

06

What researchers measure

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.

    Time frame: Baseline, 10-15 minutes after intervention

07

Study locations

1 site
  • The University of Texas Health Science Center at Houston
    Houston, Texas 77030, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

2 registry updates since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Oct 16, 2026
Show all 2 updates
  1. Oct 20, 2026
    Minor edits only
    + 2 other changes: conditions and contact details
  2. Oct 16, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07878429
Responsible party
Sheng Li (Professor at The University of Texas Health Science Center, Houston, The University of Texas Health Science Center, Houston) — Principal investigator
First posted
Oct 16, 2026
Start date
Oct 19, 2026 (estimated)
Primary completion
Dec 18, 2026 (estimated)
Completion
Jan 29, 2027 (estimated)
Last update
Oct 20, 2026

Study contacts

Sheng Li, PhD
Contact
Sheng.Li@uth.tmc.edu
(713) 797-7125
Shengai Li, MS
Contact
Shengai.Li@uth.tmc.edu
713-797-7561
Sheng Li, MD, PhD
principal investigator · The University of Texas Health Science Center, Houston

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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