New England Journal of Medicine Study Reports Advantages of Thalamic Stimulation Over Thalamotomy for Suppressing Tremor
MINNEAPOLIS, Feb. 17 /PRNewswire/ -- The following release was issued by Medtronic, Inc. (NYSE: MDT - news):
Electrical stimulation of the thalamus, the brain's communication center, suppresses drug-resistant tremor from Parkinson's disease and Essential Tremor as effectively as thalamotomy, an irreversible surgical procedure that destroys part of the thalamus, according to a study published in tomorrow's issue of the New England Journal of Medicine. What's more, treating tremor with thalamic stimulation resulted in greater functional improvement and fewer adverse effects among the patients in the study.
``The results of this study suggest benefits of thalamic stimulation over thalamotomy for treating patients with severe tremor that medication cannot control,' according to Erwin B. Montgomery, Jr., M.D., a neurologist specializing in movement disorders at the Cleveland Clinic Foundation. ``Not only is thalamic stimulation just as effective as thalamotomy in suppressing tremor, it's also reversible, adjustable and better at restoring patients to fuller, more active lives.'
Tremor -- the disabling, involuntary rhythmic shaking of the limbs or other parts of the body -- is the only symptom of Essential Tremor and one of the cardinal symptoms of Parkinson's disease. The two conditions afflict more than 1.5 million people in the United States.
The two-year study, conducted in Amsterdam by a team of researchers from the Academic Medical Center and the Netherlands Institute for Brain Research, involved 68 patients -- 45 with Parkinson's disease, 13 with Essential Tremor and 10 with multiple sclerosis -- whose tremor could not be controlled adequately with medication. The patients were divided at random into two groups. Half received thalamic stimulation; the other half underwent thalamotomy.
While both groups experienced similarly high levels of reduction in their tremor, patients who received thalamic stimulation outscored those who underwent thalamotomy on measures assessing improvements in 15 activities of daily living, including domestic tasks, leisure or work-related activities, and outdoor activities. In the study, 91 percent of the thalamic stimulation group and 79 percent of the thalamotomy group experienced total or almost complete suppression of their tremor after treatment.
``Thalamic stimulation resulted in greater improvement in function than thalamotomy, according to both objective and subjective measures,' the researchers write. ``Patients in the thalamic stimulation group had a clinically relevant improvement in their ability to perform the activities of daily life. No such overall improvement was evident in the thalamotomy group.'
Adverse effects such as slurred speech and gait or balance abnormalities were more common among patients in the thalamotomy group than in the thalamic stimulation group -- 16 patients compared to six, respectively, after six months. ``For many patients,' according to the study, ``the benefit derived as a result of tremor control [using thalamic stimulation] outweighs the side-effects of treatment.'
Thalamic stimulation for the treatment of tremor became commercially available in the United States in August 1997 when the FDA cleared Medtronic Activa© Tremor Control Therapy, the first new approach to treating tremor in 30 years. The therapy has been available in Europe, Australia and Canada since 1995, and thousands of people worldwide have received it.
Activa Tremor Control Therapy delivers mild electrical stimulation to the thalamus to block the errant brain signals that cause tremor. The implanted system includes an insulated wire lead that is surgically implanted deep within the thalamus. The lead is connected by an extension wire under the skin to a neurostimulator (similar to a cardiac pacemaker), also implanted under the skin near the collarbone.
Patients control the stimulation by passing a hand-held magnet over the implanted neurostimulator to turn it on or off, or to increase or decrease stimulation depending on their tremor suppression needs. To achieve maximum benefit, physicians can adjust the stimulation non-invasively using a console programmer to deliver the precise stimulation needed for each individual patient.
Patients interested in Activa Tremor Control Therapy should consult their physician or a neurologist specializing in movement disorders to discuss risks and benefits and to assess whether this therapy is appropriate for them. For more information, patients and physicians can call (800) 664-5111, ext. 1010. Essential Tremor, the most common neurological disease in the United States, affects at least one million Americans. In addition, more than 500,000 people suffer from tremor associated with Parkinson's disease, a progressive and degenerative neurological condition.
Medtronic, Inc., headquartered in Minneapolis, is the world's leading medical technology company, providing lifelong solutions for people with chronic disease. Its Internet address is medtronic.com
SOURCE: Medtronic, Inc.
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Hmmm. Missed the 1997 release of this equipment.
Jack |
