Safety of Cortical Stimulation in Patients with Hemiparetic Stroke

Completed

Phase N/A Results

Trial Description

To assess the safety of targeted subthreshold epidural cortical stimulation, concurrent with intensive rehabilitation therapy in patients with hemiparesis due to stroke.

Interventions

  • Electrical stimulation Device
    Intervention Desc: This category includes any form of electrical stimulation intended to improve motor function or pain after stroke.

Trial Design

Multi-center, non-blinded, randomized trial.

Patient Involvement

Patients will be randomized to receive either rehabilitation with or without cortical stimulation. Rehabilitation and cortical stimulation continue for 3 weeks, 5 days per week. Stroke scale and functional scale measurements are obtained at baseline, during the 3 weeks of treatment and 1, 4, 8 and 12 weeks post treatment.

Outcomes

Type Measure Time Frame Safety Issue
Primary Safety of targeted subthreshold epidural cortical stimulation.
Secondary To evaluate the efficacy of this approach within subjects before and after treatment.

Sponsors

Northstar Neuroscience