Stroke Clinical Trial
— RESTOREOfficial title:
Rehab With Electrical Stimulation Therapy to Optimize Rehabilitation Effect (RESTORE): A Pivotal Study
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 |
Verified date | October 2023 |
Source | Enspire DBS Therapy, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The RESTORE Stroke Study will evaluate the safety and effectiveness of DBS+Rehab for treating arm weakness and reduced function after a stroke.
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 |
Country | Name | City | State |
---|---|---|---|
United States | Cleveland Clinic | Cleveland | Ohio |
Lead Sponsor | Collaborator |
---|---|
Enspire DBS Therapy, Inc. |
United States,
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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04043052 -
Mobile Technologies and Post-stroke Depression
|
N/A | |
Recruiting |
NCT03869138 -
Alternative Therapies for Improving Physical Function in Individuals With Stroke
|
N/A | |
Completed |
NCT04034069 -
Effects of Priming Intermittent Theta Burst Stimulation on Upper Limb Motor Recovery After Stroke: A Randomized Controlled Trial
|
N/A | |
Completed |
NCT04101695 -
Hemodynamic Response of Anodal Transcranial Direct Current Stimulation Over the Cerebellar Hemisphere in Healthy Subjects
|
N/A | |
Terminated |
NCT03052712 -
Validation and Standardization of a Battery Evaluation of the Socio-emotional Functions in Various Neurological Pathologies
|
N/A | |
Completed |
NCT00391378 -
Cerebral Lesions and Outcome After Cardiac Surgery (CLOCS)
|
N/A | |
Recruiting |
NCT06204744 -
Home-based Arm and Hand Exercise Program for Stroke: A Multisite Trial
|
N/A | |
Active, not recruiting |
NCT06043167 -
Clinimetric Application of FOUR Scale as in Treatment and Rehabilitation of Patients With Acute Cerebral Injury
|
||
Active, not recruiting |
NCT04535479 -
Dry Needling for Spasticity in Stroke
|
N/A | |
Completed |
NCT03985761 -
Utilizing Gaming Mechanics to Optimize Telerehabilitation Adherence in Persons With Stroke
|
N/A | |
Recruiting |
NCT00859885 -
International PFO Consortium
|
N/A | |
Recruiting |
NCT06034119 -
Effects of Voluntary Adjustments During Walking in Participants Post-stroke
|
N/A | |
Completed |
NCT03622411 -
Tablet-based Aphasia Therapy in the Chronic Phase
|
N/A | |
Completed |
NCT01662960 -
Visual Feedback Therapy for Treating Individuals With Hemiparesis Following Stroke
|
N/A | |
Recruiting |
NCT05854485 -
Robot-Aided Assessment and Rehabilitation of Upper Extremity Function After Stroke
|
N/A | |
Active, not recruiting |
NCT05520528 -
Impact of Group Participation on Adults With Aphasia
|
N/A | |
Completed |
NCT03366129 -
Blood-Brain Barrier Disruption in People With White Matter Hyperintensities Who Have Had a Stroke
|
||
Completed |
NCT05805748 -
Serious Game Therapy in Neglect Patients
|
N/A | |
Completed |
NCT03281590 -
Stroke and Cerebrovascular Diseases Registry
|
||
Recruiting |
NCT05621980 -
Finger Movement Training After Stroke
|
N/A |