RecruitingNot ApplicableNCT05701280
Pilot/Pivotal Study of DBS+Rehab After Stroke
Rehab With Electrical Stimulation Therapy to Optimize Rehabilitation Effect (RESTORE): A Pivotal Study
Sponsor
Enspire DBS Therapy, Inc.
Enrollment
202 participants
Start Date
Feb 3, 2023
Study Type
INTERVENTIONAL
Conditions
Summary
The RESTORE Stroke Study will evaluate the safety and effectiveness of DBS+Rehab for treating arm weakness and reduced function after a stroke.
Eligibility
Min Age: 21 Years
Inclusion Criteria1
- Ischemic stroke, with an initial incident occurring between 12 months to 6 years before implant, resulting in residual upper extremity hemiparesis.
Exclusion Criteria2
- Previous or subsequent cerebrovascular events resulting in residual upper extremity impairment
- Brain lesions with significant involvement of the brainstem, cerebellum, or thalamus
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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.
Locations(10)
View Full Details on ClinicalTrials.gov
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NCT05701280
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