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Enhancing Post-Stroke Recovery

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REVITALIZING STROKE RECOVERY

Enspire DBS Therapy, Inc. supports stroke recovery patients seeking to restore arm motor function. Patients suffering from continued arm weakness and impaired function may see improvement using Deep Brain Stimulation (DBS) in combination with rehabilitation therapy during stroke recovery. DBS therapy may re-establish neurological input by stimulating the natural cerebral pathways within the brain. Unlike other stroke recovery therapies, including cortical stimulation, Enspire DBS offers a robust method to mediate the effects of stimulation and stroke rehabilitation.

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).
Clinical Trial Interest Form

If you are interested in learning more about our clinical trial, please fill out the form below and we will get in touch with you.

Fill out my online form.
Referrals

To refer patients, please contact the Principal Investigator:

Dr. Andre Machado, MD, PhD
Center for Neurological Restoration
Cleveland Clinic Neurological Institute
9500 Euclid Avenue
Cleveland, OH 44195

Alexandria Wyant
Study Coordinator
216-444-1179
wyanta@ccf.org

CONTACT
ADDRESS
35 River St. Suite 14
Chagrin Falls OH 44022