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

2. august 2026 oppdatert 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.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

50

Fase

  • Fase 2
  • Fase 1

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studer Kontakt Backup

Studiesteder

  • Forente stater
    • Alabama
      • Birmingham, Alabama, Forente stater, 35233
        • University of Alabama at Birmingham
        • Ta kontakt med:
        • Ta kontakt med:

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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
Andre navn:
  • taVNS

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Phase 1 Hypotension Symptoms Immediately before taVNS is applied
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Phase 1 Blood Pressure Immediately before taVNS is applied
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

University of Alabama at Birmingham

Etterforskere

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

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. november 2026

Primær fullføring (Antatt)

15. desember 2027

Studiet fullført (Antatt)

15. desember 2027

Datoer for studieregistrering

Først innsendt

6. april 2026

Først innsendt som oppfylte QC-kriteriene

24. april 2026

Først lagt ut (Faktiske)

1. mai 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

5. august 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

2. august 2026

Sist bekreftet

1. august 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • IRB-300015896
  • UAB (Annen identifikator: UAB)

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

IPD-planbeskrivelse

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.

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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