Pilot/Pivotal Study of DBS+Rehab After Stroke
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21+
SponsorEnspire DBS Therapy, Inc.
About this trial
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
Qualifiers
Ischemic stroke, with an initial incident occurring between 12 months to 6 years before implant, resulting in residual upper extremity hemiparesis.
Disqualifiers
Previous or subsequent cerebrovascular events resulting in residual upper extremity impairment
Brain lesions with significant involvement of the brainstem, cerebellum, or thalamus
Trial design
Treatments tested in this trial
- Deep Brain Stimulation
- Rehabilitation
Treatment groups
202 Participants
are divided into 2 treatment groupsLocations
10Arizona
Barrow Neurological Institute (BNI)85013, Phoenix United States
Florida
Mayo Clinic Florida32224, Jacksonville United States
Maryland
Johns Hopkins School of Medicine21218, Baltimore United States
Massachusetts
Massachusetts General Hospital02114, Boston United States
Sponsors and collaborators
Enspire DBS Therapy, Inc.
Lead sponsor
Source ClinicalTrials.gov