NCT05701280

Pilot/Pivotal Study of DBS+Rehab After Stroke

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 202 (estimated)
• Sponsor: Enspire DBS Therapy, Inc. · Industry
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Stroke
• Upper Extremity Paresis

Interventions

Type	Name	Description
DEVICE	Deep Brain Stimulation	Deep Brain Stimulation (DBS) of the dentate nucleus area of the cerebellum plus motor rehabilitation to improve upper-extremity function.
OTHER	Rehabilitation	Motor rehabilitation to improve upper-extremity function.

Timeline

• Start date: 2023-02-03
• Primary completion: 2026-06-01
• Completion: 2030-06-01
• First posted: 2023-01-27
• Last updated: 2026-01-21

Locations

10 sites across 1 country: United States

Regulatory

• FDA-regulated device study