NCT05701280 Pilot/Pivotal Study of DBS+Rehab After Stroke
| 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 | 2027-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 202 participants in total. It began in 2023-02-03 with a primary completion date of 2027-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
Frequently Asked Questions
Who can join the NCT05701280 clinical trial?
This trial is open to participants of all sexes, aged 21 Years or older, studying Stroke. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05701280 currently recruiting?
Yes, NCT05701280 is actively recruiting participants. Visit ClinicalTrials.gov or contact Enspire DBS Therapy, Inc. to inquire about joining.
Where is the NCT05701280 trial being conducted?
This trial is being conducted at Phoenix, United States, Jacksonville, United States, Baltimore, United States, Boston, United States and 6 additional locations.
Who is sponsoring the NCT05701280 clinical trial?
NCT05701280 is sponsored by Enspire DBS Therapy, Inc.. The trial plans to enroll 202 participants.
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