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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05701280
Other study ID # REDD 0084
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date February 3, 2023
Est. completion date June 2030

Study information

Verified date October 2023
Source Enspire DBS Therapy, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 202
Est. completion date June 2030
Est. primary completion date June 2025
Accepts healthy volunteers No
Gender All
Age group 21 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
United States Cleveland Clinic Cleveland Ohio

Sponsors (1)

Lead Sponsor Collaborator
Enspire DBS Therapy, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Fugl-Meyer Assessment, Upper Extremity sub-scale (FMA-UE) Exploratory endpoints will be examined for the group originally assigned to Control treatment after crossover. Week-32, Week-40 and Week 52
Primary Fugl-Meyer Assessment, Upper Extremity sub-scale (FMA-UE) The change in FMA-UE is significantly greater for subjects who receive Test treatment (Tt) than Control treatment (Ct). Week-12 to Week-32
Secondary Fugl-Meyer Assessment, Upper Extremity sub-scale (FMA-UE) The change in FMA-UE for subjects who receive Test treatment (Tt) is significantly above a clinically important difference (CID) Week-12 to Week-32
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