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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-02-28

Study Completion Date

2014-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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VNS

VNS (vagus nerve stimulation) paired with rehabilitation as provided by the Vivistim System.

Group Type EXPERIMENTAL

Vivistim System

Intervention Type DEVICE

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

Rehab Only

Rehabilitation only (no implant, no VNS)

Group Type ACTIVE_COMPARATOR

Rehab Only

Intervention Type OTHER

Rehabilitation without device implant and VNS

Interventions

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Vivistim System

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

Intervention Type DEVICE

Rehab Only

Rehabilitation without device implant and VNS

Intervention Type OTHER

Other Intervention Names

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VNS, vagus nerve stimulation, paired VNS

Eligibility Criteria

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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

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No