Stroke Motor Recovery Trial - Phase II

Completed

Phase N/A Results

Trial Description

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.

Interventions

Trial Design

Multi-center, single-blinded randomized investigational device trial.

Patient Involvement

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.

Outcomes

Type Measure Time Frame Safety Issue
No outcomes associated with this trial.

Sponsors

Northstar Neuroscience - Seattle