Pilot/Pivotal Study of DBS+Rehab After Stroke (RESTORE)

October 5, 2023 updated by: Enspire DBS Therapy, Inc.

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

202

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Recruiting
        • Cleveland Clinic
        • Contact:
        • Principal Investigator:
          • Andre Machado, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fugl-Meyer Assessment, Upper Extremity sub-scale (FMA-UE)
Time Frame: Week-12 to Week-32
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fugl-Meyer Assessment, Upper Extremity sub-scale (FMA-UE)
Time Frame: 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)
Week-12 to Week-32

Other Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Enspire DBS Therapy, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 3, 2023

Primary Completion (Estimated)

June 1, 2025

Study Completion (Estimated)

June 1, 2030

Study Registration Dates

First Submitted

January 9, 2023

First Submitted That Met QC Criteria

January 17, 2023

First Posted (Actual)

January 27, 2023

Study Record Updates

Last Update Posted (Actual)

October 6, 2023

Last Update Submitted That Met QC Criteria

October 5, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REDD 0084

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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