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

Sponsor

Enspire DBS Therapy, Inc. (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05701280

Collaborator

(none)

202

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Stroke Upper Extremity Paresis	Device: Deep Brain Stimulation Other: Rehabilitation	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

202 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Double-blinded, randomized, parallel study with partial crossover.Double-blinded, randomized, parallel study with partial crossover.

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Masking Description:

Participants, Care Providers (Therapists), Investigators, and Outcome Assessors do not know to which group the participants are randomized.

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Feb 1, 2023

Anticipated Primary Completion Date :

Jun 1, 2025

Anticipated Study Completion Date :

Jun 1, 2030

Arms and Interventions

Arm	Intervention/Treatment
Experimental: DBS+Rehab Active-DBS combined with motor rehabilitation	Device: Deep Brain Stimulation Deep Brain Stimulation (DBS) of the dentate nucleus area of the cerebellum plus motor rehabilitation to improve upper-extremity function.
Active Comparator: Rehab Control-DBS combined with motor rehabilitation	Other: Rehabilitation Motor rehabilitation to improve upper-extremity function.

Arm

Intervention/Treatment

Experimental: DBS+Rehab

Active-DBS combined with motor rehabilitation

Device: Deep Brain Stimulation

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

Active Comparator: Rehab

Control-DBS combined with motor rehabilitation

Other: Rehabilitation

Motor rehabilitation to improve upper-extremity function.

Outcome Measures

Primary Outcome Measures

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

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)

Other Outcome Measures

Fugl-Meyer Assessment, Upper Extremity sub-scale (FMA-UE) [Week-32, Week-40 and Week 52]
Exploratory endpoints will be examined for the group originally assigned to Control treatment after crossover.

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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