Rehab with Electrical Stimulation Therapy to Optimize Rehabilitation Effect (RESTORE): A Pivotal Study
Details
Status
Open: Currently recruiting participants.
Closed: Recruitment either has not started or has paused or completed.
Study Type
Interventional (clinical trials): Test treatments.
Observational: Conduct surveys and interviews, study medical records and otherwise observe people or groups over time.
Interventional
Study Phase
Each study phase tests different aspects of the medication or treatment:
- Phase I: safety and dosing
- Phase II: effectiveness and side effects
- Phase III: efficacy compared to standard treatments
- Phase IV: long-term safety after approval for use
Unspecified
Location(s)
Johns Hopkins study sites. Additional study locations may be found on ClinicalTrials.gov.
The Johns Hopkins Hospital
1800 Orleans St Baltimore, MD 21287
Keywords
Contact Us
Clinical Trials Website Interest FormBrief Summary
For this study, a DBS Lead will be surgically implanted in the back part of your brain (cerebellum) on the opposite side from where your stroke occurred. The DBS Lead is anchored in place using a Burr Hole Cover. The DBS Lead is connected to an Extension that is tunneled under your skin. The Extension is connected to a Neurostimulator that will be implanted under the skin near your collarbone.
Participants will be required to come for several Study Visits, which will include imaging, assessment, surgery, programming and rehabilitation therapy
There will be:
- About 11 Study Visits to complete assessments, exams, and imaging
- About 6 Study Visits to program the DBS device
- 2-3 surgeries, one or two to implant the DBS device and then, if you choose, one to remove the DBS device
- 24 in-clinic rehab sessions occurring 3 times per week for 2 months
- 12 in-clinic or telehealth video calls 1 time per week for 3 months
- Depending on which group you are assigned, you may have an additional 24 in-clinic rehab sessions occurring 3 times per week for 2 months, and an additional 12 in-clinic or telehealth video calls 1 time per week for 3 months.
Eligibility
- Age 22 or older
- Ischemic Stroke that occurred more than 10 months ago
- Moderate to severe arm impairment from a stroke
- Active extension of the wrist and two other digits plus active thumb movement