Pilot/Pivotal Study of DBS+Rehab After Stroke (RESTORE)

Enspire DBS Therapy

Status

Enrolling

Conditions

Upper Extremity Paresis

Stroke

Treatments

Device: Deep Brain Stimulation

Other: Rehabilitation

Study type

Interventional

Funder types

Industry

Identifiers

NCT05701280

REDD 0084

Details and patient eligibility

About

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

Full description

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.

Enrollment

202 estimated patients

Sex

All

Ages

21+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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