Stroke, Upper Extremity Paresis
Conditions
Keywords
Ischemic Stroke, Deep Brain Stimulation, DBS, Physical Therapy, Rehabilitation, Brain Stimulation
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.
Interventions
DEVICEDeep Brain Stimulation
Deep Brain Stimulation (DBS) of the dentate nucleus area of the cerebellum plus motor rehabilitation to improve upper-extremity function.
OTHERRehabilitation
Motor rehabilitation to improve upper-extremity function.
Sponsors
Enspire DBS Therapy, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Participants, Care Providers (Therapists), Investigators, and Outcome Assessors do not know to which group the participants are randomized.
Intervention model description
Double-blinded, randomized, parallel study with partial crossover.
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fugl-Meyer Assessment, Upper Extremity sub-scale (FMA-UE) | Week-12 to Week-32 | The change in FMA-UE is significantly greater for subjects who receive Test treatment (Tt) than Control treatment (Ct). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fugl-Meyer Assessment, Upper Extremity sub-scale (FMA-UE) | 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) |
Countries
United States
Outcome results
None listed