Revitalizing Stroke Recovery

RE-ESTABLISHES INPUT

Re-establishes neurological input during stroke rehabilitation

DEEP STIMULATION

Enables deep stimulation to broadly influence brain functions

PROVEN SAFETY

Long history of proven safety and tolerance in other indications

CORTICAL EXCITABILITY

Promotes excitability of the cortex and plasticity around the stroke

MOTOR FUNCTION IMPROVEMENT

30% - 50% improvement in motor function vs. sham control observed in pre-clinical testing

INCREASED NUMBER OF WELL FORMED SYNAPSES

2x well-formed synapses observed in perilesional cortex vs. sham control in pre-clinical testing

CLINICAL TRIAL

We are conducting a clinical trial to evaluate if Deep Brain Stimulation for Stroke is safe and to help understand if Deep Brain Stimulation plus Physical Therapy (DBS + Rehab) may improve arm function in patients who continue to have significant impairment after stroke.

CAUTION—Investigational device. Limited by United States law to investigational use.

Study Activities

Patients enrolled in this study will receive a DBS System and will participate in a weekly rehabilitation therapy program for approximately 9 months.
For a portion of this time, all patients will receive DBS to evaluate the effect of DBS+Rehab on motor recovery beyond Rehab alone.
The majority of all study visits will occur within 1 year.
Patients will not be charged for trial related appointments or procedures. Transportation and travel accommodations can be provided.

Participation

Volunteers who have suffered from a stroke and continue to have arm weakness and impaired function.
Index stroke 12 to 36 months prior (one-time stroke that occurred 1-3 years ago).
Unilateral MCA ischemic stroke (stroke due to a blocked blood vessel).
Moderate to severe upper-extremity hemiparesis (severe weakness in one arm).
Absence of seizures or seizure disorder (no seizures since time of stroke).
Not contraindicated for MRI (able to have an MRI).