VNS During Rehabilitation for Improved Upper Limb Motor Function After Stroke

Study Overview
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Brief Summary
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The primary study objectives are to assess the safety and feasibility of the therapy, including the surgical intervention and stimulation, as well as to provide information on the appropriateness of the study test measures (assessments) and to provide a basis for sample size calculations for a larger, pivotal study.

Official Title
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Study MT-St-02 - Stroke - A Randomized Pilot Study Assessing Vagus Nerve Stimulation (VNS) During Rehabilitation for Improved Upper Limb Motor Function After Stroke (MicroTransponder's Vivistim System)

Conditions
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Upper Limb Deficits, Stroke

Intervention / Treatment
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* Device: Vagus Nerve Stimulation (VNS)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: History of ischemic stroke that occurred at least 4 months prior to enrollment, but not more than 24 months prior Age >30 years and <80 years Right or left sided weakness of upper extremity UEFM score within designated range. At least 10 degrees of wrist extension, 10° of thumb abduction/extension, and at least 10° of extension in at least 2 additional digits Exclusion Criteria: History of hemorrhagic stroke Any deficits in language or cognitive functioning that hinders participation, for example, (aphasia) or unable to follow 2 step commands. Significant sensory loss. Presence of ongoing dysphagia or aspiration difficulties. Active major neurological or psychiatric diagnosis that would likely interfere with study protocol including prior history of brain lesions (including dementia, etc.), and current alcohol abuse, drug abuse, or epilepsy. Subject receiving any therapy (medication or otherwise) at study entry that would interfere with VNS (e.g. drugs that interfere with neurotransmitter mechanisms). Additionally, no psychoactive medications - including nicotine - may be used during the acute study. Prior injury to vagus nerve - either bilateral or unilateral (e.g., injury during carotid endarterectomy) Severe depression Not considered candidate for a device implant surgery (history of adverse reactions to anesthetics, poor surgical candidate in surgeon's opinion, etc.) Any other implanted device such as a pacemaker or other neurostimulator; any other investigational device or drug Medical or mental instability (diagnosis of personality disorder, psychosis, or substance abuse) Pregnant or plan on becoming pregnant or breastfeeding during the study period Currently require, or likely to require, diathermy during the study duration Any health problem requiring surveillance with MRI imaging Active rehabilitation within 4-weeks prior to therapy Botox injections or any other non-study active rehabilitation of the upper extremity 4-weeks prior to and during therapy Severe spasticity of the upper limb

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vagus Nerve Stimulation (VNS) + Rehabilitation (1)<br>This group receives vagus nerve stimulation during rehabilitation. VNS and rehabilitation are the interventions. | Device: Vagus Nerve Stimulation (VNS)<br> <br> * Other names: VNS;|
| Active Comparator: Vagus Nerve Stim (VNS) + Rehabilitation (2) - Comparator<br>This group receives rehabilitation and VNS, but the VNS is different than given in the other group (rehabilitation is the only true intervention in this group). It may not be as effective as the other group's settings. Both groups receive the same amount of rehabilitation. | Device: Vagus Nerve Stimulation (VNS)<br> <br> * Other names: VNS;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Upper Extremity Fugl-Meyer (UEFM) | Measurement of impairment, minimum value 0, maximum value 66, higher score means a better outcome. Subscales are summed. | 6-weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Wolf Motor Function Test Functional Assessment (WMFT) | Measurement of upper limb function/mobility. For Functional Assessment - minimum is 0 and maximum is 3. A higher score means a better outcome. | 6-weeks |