Vagus Nerve Stimulation Paired With Rehabilitation in the Home Environment for People With Chronic Post-Stroke Upper Limb Deficits (VNS-REHAB At-Home): Protocol for a Feasibility Trial.
Background and Rationale: Paired vagus nerve stimulation (VNS) has emerged as a safe and effective therapy to reduce upper limb (UL) motor deficits and improve motor function in individuals with chronic ischemic stroke with moderate-to-severe arm impairment. VNS paired with rehabilitation motor task...
| Publicado en: | Advances in Rehabilitation Science & Practice Vol. 14; pp. 1 - 12 |
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| Autores principales: | , , , , , , , , |
| Formato: | pictorial protocol tables/charts Journal Article |
| Publicado: |
Sage Publications Inc.
12/24/2025
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| Acceso en línea: | Ver este registro en EBSCOhost |
| fields | @attributes: recordID: 1 pdfLink: plink: https://search.ebscohost.com/login.aspx?direct=true&db=ccm&AN=190575666&site=ehost-live header: @attributes: shortDbName: ccm uiTerm: 190575666 longDbName: CINAHL Complete uiTag: AN controlInfo: bkinfo: dissinfo: jinfo: jid: 27536351 N7A5 jtl: Advances in Rehabilitation Science & Practice issn: 27536351 maglogo: Y pubinfo: dt: 12/24/2025 vid: 14 pid: 344 pub: Sage Publications Inc. place: Thousand Oaks, California artinfo: ui: 190575666 190575666 190575666 10.1177/27536351251406666 190575666 ppf: 1 ppct: 11 formats: fmt: – @attributes: type: T – @attributes: type: P tig: atl: Vagus Nerve Stimulation Paired With Rehabilitation in the Home Environment for People With Chronic Post-Stroke Upper Limb Deficits (VNS-REHAB At-Home): Protocol for a Feasibility Trial. aug: au: Doherty, Shannon J. Patel, Ruchi Spinelli-Guglielmo, Lisa Zera, Sarah M. Antares, Kathleen A. Diedrich, Annie Adham Hinds, Reema Engineer, Navzer D. Prudente, Cecília N. affil: MicroTransponder, Inc. Austin, TX, USA sug: subj: Vagal Stimulation Stroke Rehabilitation Home Rehabilitation Combined Modality Therapy Upper Extremity Pathology Chronic Disease Stroke Patients Patient Safety Patient Compliance Attitude of Health Personnel Patient Attitudes ab: Background and Rationale: Paired vagus nerve stimulation (VNS) has emerged as a safe and effective therapy to reduce upper limb (UL) motor deficits and improve motor function in individuals with chronic ischemic stroke with moderate-to-severe arm impairment. VNS paired with rehabilitation motor tasks led by an occupational or physical therapist is typically done in-clinic during initial treatment. Attending regular outpatient sessions can be difficult for individuals with limited mobility/transportation. Objectives: The primary objective of the VNS-REHAB At-Home study is to assess the feasibility, safety, compliance, and therapist/patient acceptance of delivering up to 36 hours of therapist-activated VNS paired with UL rehabilitation in a home setting. Secondary objectives include evaluating improvements in UL impairment and function. Trial Design: The acute stage is therapist-activated VNS therapy paired with at home rehabilitation in 1- to 2-hour sessions up to 5 times per week for up to 18 weeks, with a maximum of 36 total hours of therapist visit duration. The long-term stage is a follow-up period of up to 2 years during which participants continue self-activated VNS at home using a magnet during functional tasks. Study Setting: Therapist-activated Paired VNS will be done in the participant's home. Eligibility Criteria: Participants implanted or scheduled to be implanted commercially with the Vivistim Paired VNS System and assessed as able to receive therapist-activated VNS in the home setting. Interventions: The study will use mobile therapists in the participant's home instead of a clinic for the initial treatment phase. Paired VNS will be done according to the manufacturer's instructions for use. Outcomes: The primary endpoint is the number of individuals who complete at least 24 hours of therapy provided in the home setting by a therapist within an 18-week period. Secondary endpoints are change from baseline in assessment measures and patient-reported outcomes. Sample Size: Up to 150 participants. pubtype: Academic Journal doctype: pictorial protocol tables/charts Journal Article ougenre: Article language: English refInfo: holdings: @attributes: islocal: N |
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