Paired Vagus Nerve Stimulation (VNS) With Rehabilitation for Upper Limb Function Improvement After Stroke

A Proof-of-Concept Pilot Study Assessing Vagus Nerve Stimulation (VNS) Paired With Rehabilitation for Improved Upper Limb Function After Stroke (MicroTransponder's Vivistim System)

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01669161

Enrollment

Registered

2012-08-20

Start date

2013-02-28

Completion date

2014-12-31

Last updated

2016-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stroke

Keywords

Upper, Limb, Deficits, Rehabilitation, VNS

Brief summary

Patients (UK only) at least 6 months post stroke, with upper limb deficits, may enroll. Patients will be randomized to one of two groups - a group implanted with a device that allows pairing VNS with rehabilitation and a group that only receives rehabilitation (no implant). Patients have two baseline evaluations, one evaluation after implant but before initiation of treatment, and then six weeks of rehabilitation or rehabilitation + VNS, followed by post acute therapy evaluations at 1, 7, and 30 days after the 6-weeks of treatment. The intent is to assess safety and provide preliminary effectiveness information for VNS for upper limb functional improvement after stroke. Implanted patients may receive longer-term treatment and follow-up after the acute study.

Interventions

DEVICEVivistim System

The Vivistim System provides vagus nerve stimulation (VNS) with rehabilitation movements.

OTHERRehab Only

Rehabilitation without device implant and VNS

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

Inclusion criteria

Major Inclusion Criteria: 1. History of unilateral supratentorial ischemic stroke that occurred at least 6 months prior 2. Age \> 18 years and \< 80 years 3. Right or left sided weakness of upper extremity Major

Exclusion criteria

1. Hemorrhagic stroke 2. Any deficits in language or attention that interferes with reasonable study participation 3. Presence of significant apraxia 4. Profound Sensory loss 5. Active major neurological or psychiatric diagnosis that would likely interfere with study protocol including alcohol or drug abuse

Design outcomes

Primary

Measure	Time frame	Description
Safety	6-weeks	Assessment of adverse events and serious adverse events.

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 3, 2026