Pain ManagementNCT07659743
BreEStim in Managing Neuropathic Pain After Spinal Cord Injury (SCI)
A study testing Active BreEStim Treatment and The TENS Treatment in people with Pain Management, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 22 to 80 years
- Conditions the study is for
- Pain Management
- What is being tested?
- Active BreEStim Treatment and The TENS Treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Jan 2027to 30 Sep 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
Sheng Li, MD, PhD, 713-797-7125, sheng.li@uth.tmc.edu
Shengai Li, 713-797-7561, shengai.li@uth.tmc.edu
About this study
Official 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)
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
- Being tested
- Active BreEStim Treatment, Sham BreEStim Treatment, The TENS Treatment
- Keywords
- neuropathic pain, BreEStim
- Medical subject headings
- Agnosia, Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active BreEStim TreatmentDevice
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 TreatmentDevice
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 TreatmentDevice
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 group | Role | What they receive |
|---|---|---|
| Active BreEStim Treatment | Experimental | Not described Receives: Device: Active BreEStim Treatment |
| Sham BreEStim Treatment | Sham comparator | Not described Receives: Device: Sham BreEStim Treatment |
| The transcutaneous electrical nerve stimulation (TENS) Treatment | Active comparator | Not described Receives: Device: The TENS Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 10-15 minutes after intervention
Secondary outcomes (2)
the difference in the percentage of responders between active BreEStim and Sham BreEStim groups
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.
Measured: Baseline, 10-15 minutes after intervention
the difference in the percentage of responders between between active BreEStim and transcutaneous electrical nerve stimulation (TENS) groups.
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.
Measured: Baseline, 10-15 minutes after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2026
- Study start4 Jan 2027 (estimated)
- Primary completion31 Jul 2029 (estimated)
- Study completion30 Sep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain ManagementStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute of Neurological Disorders and Stroke (NINDS)
- Responsible party
- Principal investigator, Sheng Li, The University of Texas Health Science Center, Houston
- Investigators
- Sheng Li, MD, PhD, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07659743
- Sponsor's protocol ID
- HSC-MS-26-0102
- Other IDs
- UG3NS139014
- Status last verified
- Oct 2026
- First submitted
- 15 Jun 2026
- Last updated
- 14 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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)
- ClinicalTrials.gov ID
- NCT07659743
- Acronym / sponsor ID
- HSC-MS-26-0102
- Conditions
- Pain Management
- Keywords
- neuropathic pain, BreEStim
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute of Neurological Disorders and Stroke (NINDS)
- Study start
- 4 Jan 2027 (estimated)
- Primary completion
- 31 Jul 2029 (estimated)
- Study completion
- 30 Sep 2029 (estimated)
- First posted
- 22 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 22 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active BreEStim TreatmentDuring 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. | Device | Active BreEStim Treatment |
| Sham BreEStim TreatmentDuring 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. | Device | Sham BreEStim Treatment |
| The TENS TreatmentDuring 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. | Device | The transcutaneous electrical nerve stimulation (TENS) Treatment |
Primary outcome
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.
2 secondary outcomes
the difference in the percentage of responders between active BreEStim and Sham BreEStim groups
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sheng Li, MD, PhD principal investigator
The University of Texas Health Science Center, Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active BreEStim Treatment and The TENS Treatment in people with Pain Management, run by The University of Texas Health Science Center, Houston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 14 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sheng Li, MD, PhD ((713) 797-7125, sheng.li@uth.tmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Pain Level as Measured by the Visual Analog Scale (VAS). (time frame: Baseline, 10-15 minutes after intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2026.