Pilot/Pivotal Study of DBS+Rehab 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

RECRUITING

Clinical Phase

NA

Total Enrollment

202 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-03

Study Completion Date

2030-06-30

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.

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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.

Conditions

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Stroke Upper Extremity Paresis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Double-blinded, randomized, parallel study with partial crossover.

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Participants, Care Providers (Therapists), Investigators, and Outcome Assessors do not know to which group the participants are randomized.

Study Groups

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DBS+Rehab

Active-DBS combined with motor rehabilitation

Group Type EXPERIMENTAL

Deep Brain Stimulation

Intervention Type DEVICE

Deep Brain Stimulation (DBS) of the dentate nucleus area of the cerebellum plus motor rehabilitation to improve upper-extremity function.

Rehab

Control-DBS combined with motor rehabilitation

Group Type ACTIVE_COMPARATOR

Rehabilitation

Intervention Type OTHER

Motor rehabilitation to improve upper-extremity function.

Interventions

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Deep Brain Stimulation

Deep Brain Stimulation (DBS) of the dentate nucleus area of the cerebellum plus motor rehabilitation to improve upper-extremity function.

Intervention Type DEVICE

Rehabilitation

Motor rehabilitation to improve upper-extremity function.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Ischemic stroke, with an initial incident occurring between 12 months to 6 years before implant, resulting in residual upper extremity hemiparesis.

Exclusion Criteria

* Previous or subsequent cerebrovascular events resulting in residual upper extremity impairment
* Brain lesions with significant involvement of the brainstem, cerebellum, or thalamus

Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No