Pilot/Pivotal Study of DBS+Rehab After Stroke

Study Overview
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Brief Summary
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The RESTORE Stroke Study will evaluate the safety and effectiveness of DBS+Rehab for treating arm weakness and reduced function after a stroke.

Detailed Description
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The RESTORE Stroke Study combines two phases of study under one protocol (pilot/pivotal). The first phase has a sample size of 40 subjects. The second phase has an estimated sample size of 162 subjects which may be adjusted based on analysis of the first phase. Each subject will be implanted with the DBS system, undergo DBS program optimization, and be randomized to test treatment (Tt) or active-control treatment (Ct). After randomization, all subjects will participate in a five-month outpatient rehabilitation therapy program. After five months of blinded randomized testing, subjects assigned to active-control treatment (Ct) will cross over to receive test treatment (Tt) and participate in a second five-month therapy program.

Official Title
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Rehab With Electrical Stimulation Therapy to Optimize Rehabilitation Effect (RESTORE): A Pivotal Study

Conditions
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Stroke, Upper Extremity Paresis

Intervention / Treatment
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* Device: Deep Brain Stimulation
* Other: Rehabilitation


Participation Criteria
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Eligibility Criteria
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Key Inclusion Criteria: Ischemic stroke, with an initial incident occurring between 12 months to 6 years before implant, resulting in residual upper extremity hemiparesis. Key Exclusion Criteria: Previous or subsequent cerebrovascular events resulting in residual upper extremity impairment Brain lesions with significant involvement of the brainstem, cerebellum, or thalamus

Ages Eligible for Study
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Minimum Age: 21 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
Interventional Model Description: Double-blinded, randomized, parallel study with partial crossover.
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DBS+Rehab<br>Active-DBS combined with motor rehabilitation | Device: Deep Brain Stimulation<br>* Deep Brain Stimulation (DBS) of the dentate nucleus area of the cerebellum plus motor rehabilitation to improve upper-extremity function.<br>|
| Active Comparator: Rehab<br>Control-DBS combined with motor rehabilitation | Other: Rehabilitation<br>* Motor rehabilitation to improve upper-extremity function.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fugl-Meyer Assessment, Upper Extremity sub-scale (FMA-UE) | The change in FMA-UE is significantly greater for subjects who receive Test treatment (Tt) than Control treatment (Ct). | Week-12 to Week-32 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fugl-Meyer Assessment, Upper Extremity sub-scale (FMA-UE) | The change in FMA-UE for subjects who receive Test treatment (Tt) is significantly above a clinically important difference (CID) | Week-12 to Week-32 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ischemic Stroke, Deep Brain Stimulation, DBS, Physical Therapy, Rehabilitation, Brain Stimulation