Pilot/Pivotal Study of DBS+Rehab After Stroke

Not Applicable

Recruiting

• Conditions: Upper Extremity Paresis; Stroke
• Interventions: Other: Rehabilitation; Device: Deep Brain Stimulation

• Registration Number: NCT05701280
• Lead Sponsor: Enspire DBS Therapy, Inc.

Brief Summary

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

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 Timeline

• Study First Submitted: 2023-01-09
• Study First Submitted QC: 2023-01-17
• Study First Posted: 2023-01-27
• Study Start: 2023-02-03
• Status Verified: 2024-09
• Last Update Submitted: 2025-05-28
• Primary Completion: 2025-06
• Last Update Posted: 2025-06-03
• Study Completion: 2030-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 202

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Rehab	Rehabilitation	Control-DBS combined with motor rehabilitation
DBS+Rehab	Deep Brain Stimulation	Active-DBS combined with motor rehabilitation

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (7)

Thomas Jefferson University; 🇺🇸 Philadelphia, Pennsylvania, United States

Barrow Neurological Institute (BNI); 🇺🇸 Phoenix, Arizona, United States

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States

Cleveland Clinic; 🇺🇸 Cleveland, Ohio, United States

Rhode Island Hospital; 🇺🇸 Providence, Rhode Island, United States

Medical University of South Carolina (MUSC); 🇺🇸 Charleston, South Carolina, United States