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Impact of VNS With Rehab on Gait Post-Stroke

8. juni 2026 opdateret af: Assaf Berger, State University of New York at Buffalo

The Impact of Vagus Nerve Stimulation Paired With Rehabilitation on Lower Limb and Gait Functions After Ischemic Stroke

This is a prospective, double-blinded, randomized controlled study to evaluate the impact of Vagus Nerve Stimulation (VNS) therapy on lower limb function.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Stroke is a major cause of disability worldwide and currently there is a lack of effective treatments to improve functional capacity of patients with long-term disability. Vagus Nerve Stimulation (VNS) is FDA-approved for rehabilitation of upper limb deficits in patient with stroke. The device (including Vagus nerve electrodes and chest generator) is permanently implanted prior to the beginning of rehabilitation as standard of care. It is activated by patients and physical therapists during a period of 4.5 months of in-clinic and home therapy. However, so far there have been no approved neuromodulation treatments to improve lower limb functions and gait, which are key for patients' quality of life and their ability to integrate with work and social cycles.

This project will evaluate the impact of VNS on lower limb functions as measured by clinical and laboratory-based analyses of gait in stroke survivors. Patients with both upper and lower limb deficits will be included in this project. After the completion of the standard upper limb VNS-rehabilitation protocol, patients will be double-blindly randomized into 2 groups: a) lower limbs and gait rehabilitation with VNS ON for the duration of therapy; b) lower limbs and gait rehabilitation with VNS OFF.

Based on prior experience with upper limb deficits, we hypothesize that rehabilitation therapy coupled with VNS neuromodulation will elicit functional improvements in lower limb deficits and gait.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

24

Fase

  • Ikke anvendelig

Kontakter og lokationer

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

Studiekontakt

  • Navn: Ellen M Carl, PhD, CCRP
  • Telefonnummer: 7260 716-218-1000
  • E-mail: ecarl@ubns.com

Undersøgelse Kontakt Backup

Studiesteder

  • Forenede Stater
    • New York
      • Buffalo, New York, Forenede Stater, 14203
        • Rekruttering
        • University at Buffalo Neurosurgery
        • Kontakt:
          • Ellen M Carl, PhD, CCRP
          • Telefonnummer: 7260 716-218-1000
          • E-mail: ecarl@ubns.com
        • Kontakt:
        • Ledende efterforsker:
          • Assaf Berger, MD
        • Underforsker:
          • Jonathan Riley, MD
        • Underforsker:
          • Sue Ann Sisto, MD

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:

  • Approved for Vagus Nerve Stimulation (VNS) and rehabilitation therapy
  • ≥22 years and ≤ 80 years
  • Only patients who elect to undergo VNS therapy for stroke-related upper limb deficits
  • Residual active movement in the affected limb's thumb and other 2 fingers
  • Stroke-related deficits in the lower limbs and gait with a Functional Ambulation Category (FAC) ≥3
  • Able to follow simple instructions and independently walk short distances with or without external support or leg orthoses, but without manual contact with another person

Exclusion Criteria:

  • Intact lower limb functions (Fugl-Meyer score=34)
  • Not a candidate for VNS therapy according to FDA guidelines
  • Pregnant patients

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: VNS ON
Receives active stimulation during therapy
Enhed: Vagus Nerve Stimulation Therapy
Implanted vagus nerve stimulation (VNS) therapy for post-stroke recovery (Vivistim System, MicroTransponder, Austin, TX, USA)
Sham-komparator: VNS OFF
No stimulation during therapy
Enhed: Vagus Nerve Stimulation Therapy
Implanted vagus nerve stimulation (VNS) therapy for post-stroke recovery (Vivistim System, MicroTransponder, Austin, TX, USA)

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Absolute Change in Functional Assessment - Fugl-Meyer Lower Extremity (FMA-LE) scale
Tidsramme: 90 days post-operation
Absolute change in FMA-LE from baseline to 90 days
90 days post-operation
Percent Change in Functional Assessment - Fugl-Meyer Lower Extremity (FMA-LE) scale
Tidsramme: 90 days post-operation
Percent change in FMA-LE from baseline to 90 days
90 days post-operation

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Absolute Change in Functional Assessment - 10-meter walk
Tidsramme: 90 days post-operation
Absolute change in gait function as assessed by the timed 10-meter walk from baseline to 90 days
90 days post-operation
Percent Change in Functional Assessment - 10-meter walk
Tidsramme: 90 days post-operation
Percent change in gait function as assessed by the timed 10-meter walk from baseline to 90 days
90 days post-operation
Absolute Change in Functional Assessment - 6-minute walk
Tidsramme: 90 days post-operation
Absolute change in gait function as assessed by the 6-minute walk from baseline to 90 days
90 days post-operation
Percent Change in Functional Assessment - 6-minute walk
Tidsramme: 90 days post-operation
Percent change in gait function as assessed by the 6-minute walk from baseline to 90 days
90 days post-operation
Absolute Change in Functional Assessment - Berg Balance Scale
Tidsramme: 90 days post-operation
Absolute change in gait function as assessed by the Berg Balance Scale from baseline to 90 days
90 days post-operation
Percent Change in Functional Assessment - Berg Balance Scale
Tidsramme: 90 days post-operation
Percent change in gait function as assessed by the Berg Balance Scale from baseline to 90 days
90 days post-operation
Absolute Change in Functional Assessment - Five Times Sit-to-Stand Test
Tidsramme: 90 days post-operation
Absolute change in gait function as assessed by the Five Times Sit-to-Stand test from baseline to 90 days
90 days post-operation
Percent Change in Functional Assessment - Five Times Sit-to-Stand Test
Tidsramme: 90 days post-operation
Percent change in gait function as assessed by the Five Times Sit-to-Stand test from baseline to 90 days
90 days post-operation
Absolute Change in Functional Assessment - Stroke Impact Scale
Tidsramme: 90 days post-operation
Absolute change in gait function as assessed by the Stroke Impact Scale from baseline to 90 days
90 days post-operation
Percent Change in Functional Assessment - Stroke Impact Scale
Tidsramme: 90 days post-operation
Percent change in gait function as assessed by the Stroke Impact Scale from baseline to 90 days
90 days post-operation
Absolute Change in Functional Assessment - 3D Motion Analysis of Gait
Tidsramme: 90 days post-operation
Absolute change in gait function as assessed by the 3D Motion Analysis of Gait from baseline to 90 days
90 days post-operation
Percent Change in Functional Assessment - 3D Motion Analysis of Gait
Tidsramme: 90 days post-operation
Percent change in gait function as assessed by the 3D Motion Analysis of Gait from baseline to 90 days
90 days post-operation

Samarbejdspartnere og efterforskere

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

Sponsor

State University of New York at Buffalo

Efterforskere

  • Ledende efterforsker: Assaf Berger, MD, University at Buffalo

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. juni 2026

Primær færdiggørelse (Anslået)

15. december 2027

Studieafslutning (Anslået)

23. februar 2028

Datoer for studieregistrering

Først indsendt

23. maj 2026

Først indsendt, der opfyldte QC-kriterier

8. juni 2026

Først opslået (Faktiske)

11. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

11. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

8. juni 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • STUDY00008984

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

UBESLUTET

IPD-planbeskrivelse

IPD will likely be shared but a plan has not yet been finalized.

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Studerer et amerikansk FDA-reguleret enhedsprodukt

Ja

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

Ingen

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