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Pilot Testing of Vagus Nerve Stimulation for Early Spinal Cord Injury Recovery (PIVOTS-Rehab)

2 augusti 2026 uppdaterad av: Rachel Cowan, University of Alabama at Birmingham

Pilot Investigation of Transauricular Vagal Nerve Stimulation Safety and Feasibility in Acute Incomplete Spinal Cord Injury Rehabilitation

This study looks at a treatment called transcutaneous auricular vagus nerve stimulation, or taVNS. taVNS uses a small device worn on the ear to gently stimulate a nerve. Researchers want to find out if this treatment is safe and well-tolerated for people who recently had a spinal cord injury (SCI).

This study will also help researchers learn whether taVNS can be safely added to standard mobility therapy, and whether it might help improve mobility.

This study has two main goals:

  1. To find out whether taVNS is safe and comfortable for people with a recent spinal cord injury.
  2. To get information on whether taVNS may help improve mobility when compared to people who completed rehabilitation before this study started.

This study has two parts.

In the first part, participants will wear the taVNS device once for a short period of time. During this part investigators will measure how participant's heart rate and blood pressure may change before, during, and after the stimulation. Investigators will also ask about how the stimulation made participants feel.

In the second part, participants will wear the taVNS device for a short time right before a mobility therapy session. During this part investigators will measure how participants heart rate and blood pressure may change before, during, and after the stimulation and during and after the walking therapy. Investigators will also ask about how the stimulation made participants feel.

Studieöversikt

Status

Har inte rekryterat ännu

Betingelser

Intervention / Behandling

Studietyp

Interventionell

Inskrivning (Beräknad)

50

Fas

  • Fas 2
  • Fas 1

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studera Kontakt Backup

Studieorter

  • Förenta staterna
    • Alabama
      • Birmingham, Alabama, Förenta staterna, 35233
        • University of Alabama at Birmingham
        • Kontakt:
        • Kontakt:

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Nej

Beskrivning

Inclusion Criteria:

  • Phase 1 Age 18 years older SCI (traumatic or non traumatic) undergoing initial inpatient rehabilitation for the SCI Any AIS severity level (A, B, C, D)
  • Phase 2 Completed phase I Participant willing to complete phase II Study physician approves participation in phase II Receives intensive gait training as a part of the care plan

Exclusion Criteria:

  • Phase 1 Age >89 years Pregnant Implanted medical device (e.g. pacemaker, cochlear implant) epilepsy Parkinson's Disease Multiple Sclerosis cerebral shunts documented arrhythmia Ear skin irritation or damage at the electrode contact location intracranial metal implants
  • Phase 2 no exclusion criteria for those who meet inclusion criteria

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: N/A
  • Interventionsmodell: Enskild gruppuppgift
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: taVNS application

This is a single arm study with two Phases.

In Phase 1 taVNS will be applied bilaterally for a brief period while the individual is in inpatient rehabilitation

In Phase 2 taVNS will be applied for a brief period immediately before each mobility therapy session while the period is in inpatient rehabilitation. The mobility therapy sessions are routine care. Frequency and intensity of these sessions are determined by the therapists.

All individuals must complete Phase 1 before starting Phase 2. Not all individuals who complete Phase 1 will be eligible for Phase 2. Please see eligibility criteria for more details.
Enhet: Transauricular vagus nerve stimulation
bilateral transauricular vagal nerve stimulation
Andra namn:
  • taVNS

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Phase 1 Hypotension Symptoms Immediately before taVNS is applied
Tidsram: Immediately before Phase 1 taVNS application
Six questions about hypotensive symptoms rated on a 0 to 10 scale, with 0 as none and 10 worst possible
Immediately before Phase 1 taVNS application
Phase 1 Hypotension Symptoms during taVNS spplication
Tidsram: During application of Phase 1 taVNS
Six questions about hypotensive symptoms rated on a 0 to 10 scale, with 0 as none and 10 worst possible
During application of Phase 1 taVNS
Phase 1 Hypotension Symptoms Immediately after taVNS is stopped
Tidsram: Immediately after Phase 1 taVNS is stopped
Six questions about hypotensive symptoms rated on a 0 to 10 scale, with 0 as none and 10 worst possible
Immediately after Phase 1 taVNS is stopped
Phase 1 Hypotension Symptoms 5 minutes after taVNS is stopped
Tidsram: 5 minutes after Phase 1 taVNS is stopped
Six questions about hypotensive symptoms rated on a 0 to 10 scale, with 0 as none and 10 worst possible
5 minutes after Phase 1 taVNS is stopped
Phase 1 taVNS Tolerability survey
Tidsram: Within 48 hours of competing Phase 1 taVNS
10 question survey addressing perceived sensation, tolerability, side effects, and open text response
Within 48 hours of competing Phase 1 taVNS
Phase 2 taVNS Tolerability survey
Tidsram: Within 48 hours of completing Phase 2 taVNS
10 question survey addressing perceived sensation, tolerability, side effects, and open text response
Within 48 hours of completing Phase 2 taVNS

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Phase 1 Blood Pressure Immediately before taVNS is applied
Tidsram: Immediately before taVNS Phase 1 application is applied
Systolic and Diastolic Blood Pressure (mmHg)
Immediately before taVNS Phase 1 application is applied
Phase 1 Blood Pressure during taVNS application
Tidsram: During taVNS Phase 1 application
Systolic and Diastolic Blood Pressure (mmHg)
During taVNS Phase 1 application
Phase 1 Blood Pressure Immediately after taVNS is stopped
Tidsram: Immediately after taVNS Phase 1 application is stopped
Systolic and Diastolic Blood Pressure (mmHg)
Immediately after taVNS Phase 1 application is stopped
Phase 1 Blood Pressure 5 minutes after taVNS is stopped
Tidsram: 5 minutes after taVNS Phase 1 application is stopped
Systolic and Diastolic Blood Pressure (mmHg)
5 minutes after taVNS Phase 1 application is stopped
Phase 2 IRF-PAI Section GG Total Mobility Score Rehabilitation Admission
Tidsram: Admission to rehabilitation
Total score on the IRF-PAI Section GG mobility. Scores range from 15 to 90. Extracted from the medical record
Admission to rehabilitation
Phase 2 IRF-PAI Section GG Total Mobility Score Rehabilitation Discharge
Tidsram: Immediately after discharge from rehabilitation
Total score on the IRF-PAI Section GG mobility. Scores range from 15 to 90. Extracted from the medical record
Immediately after discharge from rehabilitation

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

University of Alabama at Birmingham

Utredare

  • Huvudutredare: Rachel E Cowan, PhD, University of Alabama at Birmingham

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Beräknad)

1 november 2026

Primärt slutförande (Beräknad)

15 december 2027

Avslutad studie (Beräknad)

15 december 2027

Studieregistreringsdatum

Först inskickad

6 april 2026

Först inskickad som uppfyllde QC-kriterierna

24 april 2026

Första postat (Faktisk)

1 maj 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

5 augusti 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

2 augusti 2026

Senast verifierad

1 augusti 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • IRB-300015896
  • UAB (Annan identifierare: UAB)

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

NEJ

IPD-planbeskrivning

This is an internally funded study with limited personnel support. Adequate preparation of the data to ensure seamless and rigorous sharing cannot be guaranteed at the time of registration. The investigators may update the plan to share IPD in the future if additional personnel support becomes available.

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

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