'PACEMAKER' FORTREMOR APPROVED BY FDA NOW AVAILABLE AT EMORY

September 8, 1997

Media Contacts: Sarah Goodwin, 404/727-3366 - sgoodwi@emory.edu
Kathi Ovnic, 404/727-9371 - covnic@emory.edu
http://www.emory.edu/WHSC/

Three patients from Georgia are among those who participated in studies that led to last week's approval by the Food and Drug Administration (FDA) of a pacemaker-like device to control the movement disorders known as essential tremor and Parkinsonian tremor, says neurologist Jerrold L. Vitek, M.D.,Ph.D., principal investigator, and neurosurgeon Roy A.E. Bakay, M.D., co-principal investigator, of the Emory University study site.

On Aug. 4, the FDA granted approval to Medtronics Inc. of Minneapolis, MN, to market its Activa^TM Tremor Control Therapy for unilateral (one-sided) implant to treat tremor of upper extremities.

The treatment is now available at Emory for patients in whom tremor has not responded well to drug treatment. The new device is similar to a cardiac pacemaker in that mild electric pulses are delivered to a structure in the brain called the thalamus from a generator implanted within the chest. The studies showed that electric stimulation of the thalamus region deep within the brain blocks nerve signals that incite tremor.

"For the first time in three decades we have a completely new approach to treating tremor," says Dr. Bakay, who also is professor of Neurosurgery at Emory University School of Medicine. "The availability of an implanted electric stimulator that may be externally controlled to reduce or eliminate tremor will change the lives of hundreds of thousands of Americans affected by the disorder. Symptoms have nearly disappeared in most of the patients we've treated at Emory."

Tremor, as its name implies, is the uncontrollable trembling of limbs or other parts of the body that may become so disabling as to impede writing, pouring, feeding or even dressing. It is the sole symptom of the nation's most common movement disorder -- essential tremor -- which affects more than one million older adults, and it is one of four symptoms of Parkinson's disease, a progressive and degenerative neurologic disorder affecting about one half million Americans.

Until now, treatment options have involved medication or destructive surgery, says co-principal investigator Jerrold L. Vitek, M.D., Ph.D., assistant professor of Neurology at Emory.

Dr. Bakay implants the electric pulse generator just under the skin near the patient's collarbone then carefully routes an extension wire leading from the stimulator to the inner brain. The wire lead is attached to the inner skull and four electrodes extending from it are placed around the thalamus.

Once implanted, the device may be programmed externally by Dr. Vitek, who teaches the patient to turn the system on or off by passing a magnet over the programmer implanted in the chest. Patients can turn the stimulator off at night when it is not needed and turn it on during the day when tremor increases. Turning the stimulator off at night will conserve battery life. Batteries are changed every three to five years in a simple surgical procedure.

Information on receiving the treatment at Emory is available at 404/778-7777.

For more general information on The Robert W. Woodruff Health Sciences Center, call Health Sciences News and Information at 404-727-5686, or send e-mail to hsnews@emory.edu.