Upstate News

February 2, 2006
Doretta Royer 315 464-4833

SUNY Upstate begins study to test effectiveness of electrical stimulation device to aid stroke recovery

SYRACUSE, N.Y.- The most common effect of stroke is weakness to one side of the body, costing stroke survivors the ability to perform basic daily activities. A research team at SUNY Upstate Medical University is seeking volunteers to participate in a study whose findings may help stroke survivors gain better motor control of their upper extremities. SUNY Upstate is one of 18 sites in the nation to participate in the study.

Charles J. Hodge, M.D., professor and chair of the Department of Neurosurgery is SUNY Upstate’s principal investigator for the study, “Safety and Effectiveness of Cortical Stimulation in the Treatment of Upper Extremity Hemiparesis,” also known as the EVEREST study.

Among other criteria, study volunteers must: be 21 years of age or older and have experienced an ischemic (transient ischemic) stroke at least four months ago, causing muscle weakness in the shoulder, arm, wrist and hand to one side of the body; medically and neurologically stable; able to undergo magnetic resonance imaging (MRI) and an implant procedure; and sign an informed consent.

Presently, rehabilitative therapy is the only treatment for stroke patients with motor deficit. However this standard form of therapy results in little, if any, improvement of motor function in some stroke survivors.

According to Hodge, this study will determine the safety and effectiveness of electrical stimulation delivered by an implantable pulse generator (IPG) to the cerebral cortex during rehabilitation activities. The cerebral cortex is believed by the scientific community to be an important site for neuroplasticity, a process of reorganization in which new areas of the brain take over the function of stroke-damaged areas. Findings from previous laboratory and clinical studies suggest that cortical stimulation therapy is safe and appears to increase motor function in stroke survivors, more than rehabilitation alone.

“The study will provide further evidence needed to determine if this proposed method of treatment-electrical cortical stimulation given concurrently with rehabilitative activities-is safe and effective for stroke survivors,” said Hodge. “If successful, as evidenced by improved motor recovery and associated activities of daily living in stroke patients, it would likely have important health, quality of life and economic benefits for many people.”

The time commitment for an individual to complete the study is approximately eight months, consisting of up to two weeks for baseline activities, such as general health assessments and motor function testing; six weeks for rehabilitative treatment with or without use of the implantable system; and six months for follow-up.

Up to 330 patients will be enrolled in all of the investigational sites to obtain a total of up to 174 volunteers who are appropriate for the study. Of these volunteers, up to 110 will be part of an investigational group and will receive the implant of the stimulation system and undergo the targeted electrical stimulation concurrent with rehabilitation therapy.

Up to 64 patients will be randomized to the control group and will receive the same rehabilitation that is focused on upper extremity motility, without concurrent electrical stimulation.

The participants will be assessed by standardized and validated tests of function, disability, and quality of life by raters who will not be apprised of which group each volunteer is assigned. Study participants will conceal evidence of the device implant and refrain from discussing study procedures with the raters.

Electrical stimulation will be provided via a Stroke Recovery Treatment System, an investigational medical device that is comprised of fully implantable components. Components include a battery-operated pulse generator that is implanted below the collarbone area, connected to a cortical stimulation lead that is tunneled behind the ear and attached to an electrode that is sutured to the dura, the tough membrane that surrounds the brain. The implanted device system is used only during rehabilitation activities and will be removed approximately eight weeks following the completion of rehabilitation therapy. None of the implantable components directly touch the brain. All components were approved by the FDA for use in this study.

The system, designed to minimize risk to the volunteers, includes features to ensure negligible electrical risk to the patient and the ability to rapidly terminate therapy if needed. Trained study personnel initiate and monitor cortical stimulation via a handheld device that provides stimulation that is personalized and appropriate to the functional ability of each participant. A nurse or physician will be available for the duration of the rehabilitation session.

Stroke is the third-leading cause of death behind heart disease and cancer and accounts for an estimated $56 billion in direct and indirect costs each year.

An ischemic stroke is caused by clots that form and block blood flow to the brain, accounting for 80 percent of all strokes.

A transient ischemic attack (TIA) or mini-stroke is a temporary interruption of blood flow to the brain resulting in stroke symptoms that last for several minutes.

The most common warning signs of stroke are sudden numbness or weakness of face, arm or leg – especially on one side of the body (most common stroke warning sign); sudden confusion; trouble speaking or understanding; sudden trouble seeing in one or both eyes; sudden trouble walking, dizziness, loss of balance or coordination; and sudden, severe headache with no known cause.

Joining Hodge in the study from SUNY Upstate are Charles Bradshaw, Ph.D., clinical associate professor of neurology; Margaret Turk, M.D., professor of physical medicine and rehabilitation and pediatrics; and Michael Vertino, M.D., assistant professor of neurology. Study coordinator is Lorraine Padden, C.N.R.N., A.N.P.

To learn more about the study or to inquire about becoming a participant, call 1-888-546-9779.

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