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Pilot/Pivotal Study of DBS+Rehab After Stroke — RESTORE  

Stroke Clinical Trial

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

Clinical Trial Summary

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

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05701280
Study type Interventional
Source Enspire DBS Therapy, Inc.
Contact
Status Recruiting
Phase N/A
Start date February 3, 2023
Completion date June 2030
View Details
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