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Zolpidem, a hypnotic or soporific drug used to treat insomnia. Commonly known as Ambien.
Daily doses of a drug used to treat Parkinson’s disease significantly improved function in severely brain-injured people thought to be beyond the reach of treatment, scientists reported on Wednesday, providing the first rigorous evidence to date that any therapy reliably helps such patients.
The improvements were modest, experts said, and hardly amounted to a cure, or a quick means of “waking up” someone who has long been unresponsive. But the progress was meaningful, experts said, and, if replicated, would give rehabilitation doctors something they have never had: a standard treatment for injuries that are not at all standard or predictable in the ways they affect the brain.
Some 50,000 to 100,000 Americans live in states of partial consciousness, and perhaps 15,000 in an unresponsive “vegetative” condition. According to the Department of Defense, more than 6,000 veterans have had severe brain injuries since 2000 and would potentially benefit from this therapy. The new report, appearing in The New England Journal of Medicine, gives doctors a solid basis to address such injuries, if not yet a predictable outcome.
“This study puts the traumatic brain injury field on the first step of the ladder to developing scientific treatments. We’ve been trying to get there for a long time,” said Dr. Ramon Diaz-Arrastia, director of clinical research at the Center for Neuroscience and Regenerative Medicine at the Uniformed Services University of the Health Sciences in Rockville, Md., who was not involved in the research. “And there’s no reason to doubt that this therapy would also be effective in people with less severe brain injuries” than in the study.
“Hope is critical and false hope is cruel for families dealing with this,” said Susan Connors, president and chief executive of the Brain Injury Association of America, in Vienna, Va. The new findings, she added, are “a little piece of hope, the real kind.”
Doctors have long experimented with the Parkinson’s drug — amantadine hydrochloride — as well as many others to treat severe brain injuries, with mixed and uncertain results. Previous studies of amantadine suggested some benefit, but the numbers were small and experts were unsure of the findings.
The new experiment put those doubts to rest, by testing the drug against a placebo in two large groups of patients.
A consortium of researchers from 11 clinics enrolled 184 patients who recently had a traumatic brain injury from a car accident or from blows to the head. Some were in a vegetative state, breathing, their eyes open when awake, but unresponsive to commands or prompts. Others were in what is known as a minimally conscious state, able to track objects and follow commands once in a while, but not predictably.
The research team, led by Joseph T. Giacino of the J. F. K. Johnson Rehabilitation Institute in Edison, N.J., and Dr. John Whyte of the Moss Rehabilitation Research Institute, in Elkins Park, Pa., divided the patients into two groups, carefully matched for the severity of their injuries. Members of one group got two doses of amantadine a day, given through their feeding tubes. Members of the other group received placebo pills.
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