To evaluate the safety and effectiveness of the Northstar Stroke Recovery System*, an investigational implanted device, in treating patients who have reduced hand and/or arm function after stroke.
- Occupational therapy Other
- Electrical stimulation Device
Intervention Desc: This category includes any form of electrical stimulation intended to improve motor function or pain after stroke.
Multi-center, single-blinded randomized investigational device trial.
All patients will undergo fMRI to identify the region involved in function of the affected hand and/or arm, and will then be randomized into one of two treatment groups. Both treatment groups will participate in intensive rehabilitative therapy. Patients randomized to the investigational arm will undergo surgery to place an electrode on the dura at the site identified by the fMRI, connected to a pulse generator implanted below the collar bone that will administer stimulation during rehabilitation sessions that will last 2 1/2 hours for 26. The control group will have the rehabilitation sessions and follow-up only. Treatment will be followed up by assessments at 1,4,12 and 24 weeks after completion of therapy regime.
|Type||Measure||Time Frame||Safety Issue|
|No outcomes associated with this trial.|