March 1 (Bloomberg) -- A drug for Parkinson’s disease accelerated the ability of patients with severe brain injuries to open their eyes and speak, providing what researchers said is the first evidence that a medical treatment might help speed head trauma recovery.
Patients taking the medicine, amantadine, for four weeks regained cognitive functioning faster than those on a placebo, according to the 184-patient study published online yesterday in the New England Journal of Medicine. The rate of recovery declined in two weeks after treatment and it’s unknown whether the drug aided long-term improvement.
Traumatic brain injuries are the most common cause of death and disability for people ages 15 to 30, the researchers said. While amantadine is often prescribed for patients in vegetative or “minimally conscious” states after such injuries, little clinical research has been done on its safety and efficacy, said study author Joseph Giacino, director of rehabilitation neuropsychology at Spaulding Rehabilitation Hospital in Boston.
“There’s no question in my mind this is now finally some cause for optimism in a patient population that has historically been viewed as beyond help and, frankly, hopeless,” said Giacino, an associate professor at Harvard Medical School, said in a telephone interview.
The study tested patients who were in inpatient rehabilitation care after suffering a traumatic brain injury four to 16 weeks previously. Because the study was just six weeks long, it didn’t show whether amantadine, available as a generic drug, would continue to help patients recover over longer periods, the authors said.
“Our study leaves an important question open: Do we help get people to their same ultimate destination on a faster track, or do we change their ultimate destination?” said John Whyte, director of the Moss Rehabilitation Research Institute in Philadelphia and a study author, in a telephone interview. Even if it’s the former, he said, “we shouldn’t trivialize that. Psychosocially, if you are a family waiting for your family member to regain function and interact with you, it will make a lot of difference whether you have to wait a long time or a short time.”
Increasing cost restraints on health care also make speedier recoveries more important, the authors wrote.
Amantadine helped patients regain behavioral abilities such as consistently following commands and recognizing objects faster in four weeks than those taking a placebo, the study found.
At that time, 40 percent of patients on amantadine could consistently follow commands compared with 32 percent on placebo, the study showed. Two weeks after treatment stopped, 41 percent of patients on the drug were able to follow commands, compared with 39 percent on placebo.
Patients’ ability to speak declined after stopping treatment with amantadine, while it continued to improve in the placebo group. At four weeks, 39 percent of patients taking amantadine could speak intelligibly, compared with 34 percent on placebo. Two weeks after treatment, 36 percent on amantadine were able to speak intelligibly, compared with 41 percent on placebo.
That patients’ rate of recovery slowed after stopping treatment with amantadine is “more compelling evidence the drug is doing something,” Giacino said.
Amantadine is one of 10 to 15 drugs approved for other uses that are prescribed off label by doctors to treat patients with traumatic brain injury, Whyte said. Little is known about their true effect, he said.
“Because it’s such a desperate situation and these drugs are on the market for other purposes, a culture has developed where doctors treat off-label with drugs like this based on internal logic,” Whyte said. This study “says that you don’t have to pick based on logic or hypotheses; you can pick based on evidence.”
The study was funded by the National Institute on Disability and Rehabilitation Research.
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