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

18. juni 2026 opdateret af: Sheng Li, The University of Texas Health Science Center, Houston

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).

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

66

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Active BreEStim Treatment
Enhed: Active BreEStim Treatment
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-komparator: Sham BreEStim Treatment
Enhed: Sham BreEStim Treatment
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.
Aktiv komparator: The transcutaneous electrical nerve stimulation (TENS) Treatment
Enhed: The TENS Treatment
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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Pain Level as Measured by the Visual Analog Scale (VAS).
Tidsramme: 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.
Baseline, 10-15 minutes after intervention

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
the difference in the percentage of responders between active BreEStim and Sham BreEStim groups
Tidsramme: 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.
Baseline, 10-15 minutes after intervention
the difference in the percentage of responders between between active BreEStim and transcutaneous electrical nerve stimulation (TENS) groups.
Tidsramme: 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.
Baseline, 10-15 minutes after intervention

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

The University of Texas Health Science Center, Houston

Samarbejdspartnere

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

Efterforskere

  • Ledende efterforsker: Sheng Li, MD, PhD, The University of Texas Health Science Center, Houston

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. oktober 2026

Primær færdiggørelse (Anslået)

31. juli 2029

Studieafslutning (Anslået)

30. september 2029

Datoer for studieregistrering

Først indsendt

15. juni 2026

Først indsendt, der opfyldte QC-kriterier

15. juni 2026

Først opslået (Faktiske)

22. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

23. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

18. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • HSC-MS-26-0102
  • UG3NS139014 (U.S. NIH-bevilling/kontrakt)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ja

produkt fremstillet i og eksporteret fra U.S.A.

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Smertebehandling

Kliniske forsøg med Active BreEStim Treatment

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Sponsorer og samarbejdspartnere

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Betingelser

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Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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