Pilot/Pivotal Study of DBS+Rehab After Stroke

Stroke Clinical Trial

— RESTORE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05701280
• Other study ID #: REDD 0084
• Status: Recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Paresis
• Stroke
• Upper Extremity Paresis

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