- The Washington Times - Thursday, July 6, 2006

Mike Elliott was 32 years young and in top physical shape when he fell asleep on his couch one night reading a book. When he woke up, he was on the floor and could not respond to his wife’s request for him to come to bed.

In fact, it was 4 1/2 months before he could say his first sentence to his wife.

In 1992, Mr. Elliott had a stroke caused by a clot blocking blood flow to his brain. The doctors told him that he would never walk or talk again.

Fourteen years later, Mr. Elliott, a resident of Vienna, speaks well, walks six miles a day and plays nine holes of golf several times a week. Such activities work to link his brain to his body, a connection that was weakened by the brain’s lapse during the stroke.

“I had plenty of room in my brain to make those connections,” says Mr. Elliott, who has regained his motor functions and is working on strengthening his body.

Initially, Mr. Elliott could only grasp the golf club with one hand — the other hand suffered from hemiparesis, partial paralysis affecting one side of the body.

Because this debilitating condition is the most common effect of stroke, physicians across the country are researching the effectiveness of an innovative therapy called cortical stimulation to treat hemiparesis.

Mr. Elliott, who dedicates his time and energy to helping other stroke survivors find hope, says cortical stimulation sounds promising for patients who, unlike him, haven’t gained full use of their motor functions.

Northstar Neuroscience, a Seattle-based medical company, is spearheading the research and has developed an electrical device used to stimulate the brain’s surface. With its technologies, the company strives to help stroke patients and others with neurological disorders.

The company is sponsoring a clinical study called the Everest trial. If the results prove successful, cortical stimulation, in conjunction with physical rehabilitation, would be the first therapy clinically proved to reverse the devastating side effect that indiscriminately renders hands and arms partly dysfunctional in the months and years following a stroke, says John Bowers, executive vice president of Northstar Neuroscience.

After completing two successful studies that tested the safety and effectiveness of cortical stimulation among 32 total stroke survivors, Northstar Neuroscience initiated the Everest trial, which will test a larger population of patients, Mr. Bowers says.

At 18 sites across the U.S., doctors are closely monitoring stroke survivors who are test subjects using cortical stimulation combined with physical therapy. The company’s goal is to recruit a total of 151 test subjects.

Mr. Bowers says the Everest trial aims at the broad middle group of stroke survivors who are moderately to severely impaired in their hand or arm motor function.

Based on previous years of the company’s research, Mr. Bowers says a natural process called neuroplasticity occurs in stroke patients. In that process, in the period right after the stroke, the brain reorganizes and creates alternate pathways as a result of the injury.

Months to years after the stroke, however, neuroplasticity plateaus, and it is at this time that cortical stimulation, in conjunction with physical therapy, would “enhance the natural neuroplasticity so the arm could have full recovery and use,” Mr. Bowers says.

Chief Medical Officer Joel Stein, who works at the Spaulding Rehabilitation Hospital in Boston — one of the clinical research sites — speaks positively of research on cortical stimulation, which he says is on the cusp of becoming practice. Dr. Stein, an associate professor of physical medicine and rehabilitation at Harvard Medical School, recently co-wrote “Life After Stroke: The Guide to Recovering Your Health and Preventing Another Stroke.”

Cortical stimulation begins with the stroke survivor in an MRI chamber — at this point, the doctor moves the patient’s arm or hand, which causes the location of the brain that controls that motor function to light up. The doctor then makes an incision in the skull and places an electrode on the damaged portion of the patient’s brain. A wire runs under the skin from the electrode to a pulse generator, which is implanted below the patient’s collarbone.

After this procedure, the doctor only turns on the pulse generator during the patient’s physical therapy. The electric signals stimulate the brain, reinforcing neuron signals to the hand and arm as they move.

During the Everest trial, Mr. Bowers says, the cortical stimulation system is implanted for eight weeks, and the rehabilitation will be administered for six weeks. The system is removed after the therapy is finished. Mr. Bowers says the researchers often saw noticeable improvement in the first two to three weeks of the previous trials.

One hundred of the patients involved in the Everest study will have the electrode and pulse generator implanted for use during their physical therapy. The other 51 patients will engage in the same physical therapy, minus cortical stimulation. The results from both groups will be compiled and compared.

“We hope to finish the study and have all the data analyzed by the first quarter of 2008 and then submit it to the [Food and Drug Administration],” Mr. Bowers says. “Then [we hope] to have a marketable product by the first quarter of 2009.”

Jack Cochran, chairman of Inova Alexandria Hospital’s Department of Medicine, says he will wait for the results of the Everest trial to determine whether to recommend cortical stimulation for his patients.

“For people who want to be aggressive and do everything they can, [cortical stimulation] is an option,” says Dr. Cochran, who also treats patients at the largest stroke program in Virginia, at Inova Fairfax Hospital.

More info:

Stroke is the third-leading cause of death in the U.S. and the leading cause of long-term disability, according to the American Stroke Association.

Dr. Joel Stein, who recently co-wrote a book on recovering from stroke, recommends that everyone become aware of the “FAST” elements of a stroke:

• F: Facial symmetry — one side of the face droops.

• A: Arm — loss of motor function or weakness in an arm.

• S: Speech — slurred or impaired speech.

• T: Time — the sooner the stroke victim receives medical attention, the better the outcome.

Risk factors that you can control include high blood pressure, obesity, smoking, excessive alcohol intake and physical inactivity.

For more information on stroke, visit www.strokeassociation.org or call 888/4-STROKE.

For more information on Northstar Neuroscience or to see if you are a candidate for the Everest study, visit www.northstarneuro.com or call 888/546-9779.

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