DBS+Rehab for Arm Weakness After Stroke
The RESTORE Stroke Study is testing a treatment called Deep Brain Stimulation (DBS) combined with motor rehabilitation to improve arm weakness and function after a stroke. You might be able to join if you had an ischemic stroke (a stroke caused by a blood clot) between 12 months and 6 years ago, and still have arm weakness. The study will measure success by looking at changes in your arm function using a tool called the Fugl-Meyer Assessment, Upper Extremity sub-scale (FMA-UE) between 12 and 32 weeks. The current status of this study is unclear, but it plans to enroll 202 participants.
- Study design
- This is an interventional study with two phases, planning for 202 participants. It involves implanting a DBS system, then randomizing participants to either the test treatment or an active-control treatment.
- What's involved
- You would have a DBS system implanted, undergo DBS program optimization, and participate in two five-month outpatient rehabilitation therapy programs.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your arm function will be measured between 12 and 32 weeks after the start of the study.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Pilot/Pivotal Study of DBS+Rehab After Stroke
At a glance
Conditions
Where it's being run
10 sites across 10 statesWho to contact
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Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- Fugl-Meyer Assessment, Upper Extremity sub-scale (FMA-UE)Week-12 to Week-32
The change in FMA-UE is significantly greater for subjects who receive Test treatment (Tt) than Control treatment (Ct).