Multi-National Clinical Study To Focus on Effectiveness of Drug
For Treating Severe Traumatic Brain Injuries
Improvement Sought in Patients in Vegetative and Minimally Conscious
States
Edison, NJ - Patients with severe traumatic brain injuries may be
eligible to participate in an international clinical study funded by a
5-year, $3 million grant from the National Institute on Disability and
Rehabilitation Research. The study is designed to test the
effectiveness of a drug called amantadine hydrochloride for treating
patients in vegetative and minimally conscious states.
Joseph T. Giacino, PH.D., JFK-Johnson Rehabilitation Institute in
Edison, NJ, who is directing the study, said: "Many drugs are used to
try to speed the recovery of consciousness in individuals with severe
brain injuries, but there is very little research available to help
physicians select a drug that is effective in treating patients with
prolonged impairments of consciousness."
Amantadine hydrochloride, introduced in the 1960's as an antiviral
agent, has been shown to enhance the transmission of nerve impulses in
the brain, said project co-director John Whyte, M>D., Ph.D., of
MossRehab in Philadelphia. The encouraging results of earlier pilot
studies using this drug in patients recovering from disturbances in
consciousness paved the way for this major study in which as many as 180
patients are expected to be enrolled at multiple sites throughout the
United States and Germany.
Eight rehabilitation institutions are participating in the study as
members of the Consciousness Consortium. In addition to the JFK-Johnson
Rehabilitation Institute and MossRehab, the consortium includes
Braintree Rehabilitation Hospital in Braintree, Mass.; Bryn Mawr
Rehabilitation Hospital in Malvern, PA.; Fachkrankenhaus Neresheim
Hospital in Neresheim, Germany; Methodist Rehab Center in Jackson,
Mississippi; Sunnyview Hospital and Rehab Center in Schenectady, NY; and
Texas Neurorehab Center in Austin, TX. Columbia University in New York
City will function as the Data Coordinating Center for this study.
Scope of the Problem
Between 15,000 and 45,000 Americans survive severe traumatic brain
injury each year. "Survival rates have improved considerably during the
last 25 years as the result of better emergency room care and surgical
procedures, " Dr. Giacino said. Yet the average lifetime per patient
cost for care after a severe traumatic brain injury remains very high at
about $2 million, according to a 1999 National Institutes of Health
survey. In addition, the family disruption caused by involuntary role
changes is often overwhelming.
Contact:
Dr. Douglas Katz
781-348-2500, X2322
dkatz@bu.edu
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