search
Back to results

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

Primary Purpose

Stroke, Upper Extremity Paresis

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Deep Brain Stimulation
Rehabilitation
Sponsored by
Enspire DBS Therapy, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring Ischemic Stroke, Deep Brain Stimulation, DBS, Physical Therapy, Rehabilitation, Brain Stimulation

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Cleveland ClinicRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

DBS+Rehab

Rehab

Arm Description

Active-DBS combined with motor rehabilitation

Control-DBS combined with motor rehabilitation

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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)

Full Information

First Posted
January 9, 2023
Last Updated
October 5, 2023
Sponsor
Enspire DBS Therapy, Inc.
search

1. Study Identification

Unique Protocol Identification Number
NCT05701280
Brief Title
Pilot/Pivotal Study of DBS+Rehab After Stroke
Acronym
RESTORE
Official Title
Rehab With Electrical Stimulation Therapy to Optimize Rehabilitation Effect (RESTORE): A Pivotal Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 3, 2023 (Actual)
Primary Completion Date
June 2025 (Anticipated)
Study Completion Date
June 2030 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Enspire DBS Therapy, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Upper Extremity Paresis
Keywords
Ischemic Stroke, Deep Brain Stimulation, DBS, Physical Therapy, Rehabilitation, Brain Stimulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Double-blinded, randomized, parallel study with partial crossover.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Participants, Care Providers (Therapists), Investigators, and Outcome Assessors do not know to which group the participants are randomized.
Allocation
Randomized
Enrollment
202 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
DBS+Rehab
Arm Type
Experimental
Arm Description
Active-DBS combined with motor rehabilitation
Arm Title
Rehab
Arm Type
Active Comparator
Arm Description
Control-DBS combined with motor rehabilitation
Intervention Type
Device
Intervention Name(s)
Deep Brain Stimulation
Intervention Description
Deep Brain Stimulation (DBS) of the dentate nucleus area of the cerebellum plus motor rehabilitation to improve upper-extremity function.
Intervention Type
Other
Intervention Name(s)
Rehabilitation
Intervention Description
Motor rehabilitation to improve upper-extremity function.
Primary Outcome Measure Information:
Title
Fugl-Meyer Assessment, Upper Extremity sub-scale (FMA-UE)
Description
The change in FMA-UE is significantly greater for subjects who receive Test treatment (Tt) than Control treatment (Ct).
Time Frame
Week-12 to Week-32
Secondary Outcome Measure Information:
Title
Fugl-Meyer Assessment, Upper Extremity sub-scale (FMA-UE)
Description
The change in FMA-UE for subjects who receive Test treatment (Tt) is significantly above a clinically important difference (CID)
Time Frame
Week-12 to Week-32
Other Pre-specified Outcome Measures:
Title
Fugl-Meyer Assessment, Upper Extremity sub-scale (FMA-UE)
Description
Exploratory endpoints will be examined for the group originally assigned to Control treatment after crossover.
Time Frame
Week-32, Week-40 and Week 52

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karen Stevenson
Phone
216-445-0926
Email
STEVENK12@ccf.org
First Name & Middle Initial & Last Name & Degree
Andre Machado, MD, PhD

12. IPD Sharing Statement

Learn more about this trial

Pilot/Pivotal Study of DBS+Rehab After Stroke

We'll reach out to this number within 24 hrs