Pilot/Pivotal Study of DBS+Rehab After Stroke

Enspire DBS Therapy, Inc.202 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

202

Conditions

Stroke Upper Extremity Paresis

Interventions

Deep Brain StimulationDEVICE

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

RehabilitationOTHER

Motor rehabilitation to improve upper-extremity function.

Eligibility

Sex: ALLMin age: 21 Years

Medical Language ↔ Plain English

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

Locations (10)

Barrow Neurological Institute (BNI)

Phoenix, Arizona, United States

RECRUITING

Mayo Clinic Florida

Jacksonville, Florida, United States

RECRUITING

Outcomes

Primary Outcomes

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).

Time frame: Week-12 to Week-32

Secondary Outcomes

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)

Time frame: Week-12 to Week-32

Data from ClinicalTrials.gov

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