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Recruiting NCT05701280
NCT05701280 Pilot/Pivotal Study of DBS+Rehab After Stroke
◆ AI Clinical Summary
Plain-language summary for patients
| NCT ID | NCT05701280 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Enspire DBS Therapy, Inc. |
| Condition | Stroke |
| Study Type | INTERVENTIONAL |
| Enrollment | 202 participants |
| Start Date | 2023-02-03 |
| Primary Completion | 2026-06 |
Trial Parameters
Condition Stroke
Sponsor Enspire DBS Therapy, Inc.
Study Type INTERVENTIONAL
Phase N/A
Enrollment 202
Sex ALL
Min Age 21 Years
Max Age N/A
Start Date 2023-02-03
Completion 2026-06
All Conditions
Interventions
Deep Brain StimulationRehabilitation
Eligibility Fast-Check
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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.
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
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