DETROIT - Henry Ford Hospital has launched a safety study using the drug Viagra to determine if it can help patients recover from a stroke.
The study, launched this week and approved by the U.S. Food and Drug Administration, aims to help individuals regain or improve motor and speech skills as well as cognitive thinking. Viagra, or sildenafil, is a commonly prescribed drug for erectile dysfunction.
"We realized that we need to look at what we can do to help people who have had a stroke get their lives back," says Brian Silver, M.D., principal investigator and a neurologist at Henry Ford Hospital.
The hospital will enroll 84 patients in the study. Participants must be over age 18 and have suffered a moderate stroke within 72 hours of being placed in a study group.
Henry Ford Hospital has used Viagra for two Michigan patients for neurological recovery, both under a compassionate use basis.
One patient, Rene Jarinski, 43, has been treated with Viagra since suffering a stroke in July 2003. Transferred to Henry Ford from another hospital, she was diagnosed with locked in syndrome, a very uncommon condition, in which she could only move her eyes up down.
"To my knowledge she is the first patient in the United States who has been treated with Viagra specifically for stroke recovery," says Dr. Silver.
After being given doses of 50 and 100 milligrams early on, she now takes 150 milligrams daily.
"We're not certain that Viagra is helping the recovery, but she is now able to smile, eat, move all four limbs and stand up with assistance," says Silver. "Things moved slowly in the first couple of months; most of the recovery has come after the sixth month period. This is very uncommon for individuals after stroke who typically see a deceleration in recovery. Individuals with locked in syndrome rarely walk or talk again. Rene is making a recovery that doesn't follow the normal recovery curve."
Dr. Silver initially communicated with her by having her move her eyes up for yes and down for no.
"For patients like Rene, the usual treatments would be occupational therapy, speech therapy and physical therapy," says Dr. Silver. "Rene's family asked for anything else beyond the standard of care that could be provided for her. We explained that anything else would be experimental and provided on a compassionate use basis."
For a number of years Henry Ford has been researching stroke recovery using Viagra in laboratory animals with good outcomes. In this case what had been learned in the lab would be transferred to the bedside.
"What we found is that we can use certain drugs like Viagra to create new brain cells," says Michael Chopp, Ph.D., scientific director of the Neuroscience Institute at Henry Ford Hospital.
"When mice and rats with stroke are treated with Viagra, the drug provides very significant functional benefit. These animals do much better. There are far fewer functional deficits. Days later there is reduced neurological deficit and new brain cells," says Dr. Chopp.
Viagra was selected as the drug to test because it is chemically similar to other compounds shown to improve function in animals after stroke. Dr. Chopp says that Viagra activates a molecule called cyclic guanosine monophoshate in brain tissue that creates new cells in the brain.
Each year about 750,000 Americans experience a new or recurrent stroke attack. It is the nation's third leading cause of death, ranking behind diseases of the heart and all forms of cancer.
Currently, tissue plasminogen activator (t-PA) is the only approved treatment for ischemic stroke – the cause of more than 80 percent of all strokes. But the clot-dissolving drug must be administered within three hours of initial stroke symptoms for effectiveness. In addition, t-PA treatment reaches less than 5 percent of stroke victims.
Dr. Chopp is one of only a handful of researchers in the country working on "brain remodeling." By using different compounds and cell-based therapy, they are able to produce new cells and electrical connections within the brain that help people recover from stroke, or head injury.
"Think of the brain as a house," says Dr. Chopp. "If a tree falls on your house, what you want most is to fix the damage to restore your daily quality of life. Remodeling the brain, like remodeling a house, may require new plumbing, such as new blood vessels; new electrical connections or new synapses; and new rooms or new brain cells in order to regain function."
Certain drugs like Viagra create new brain cells and these cells are created in both elderly as well as young subjects. When animals with stroke are treated with Viagra, the drug provides very significant neurological functional benefit. The animals do much better on many different outcome measures, including motor function, neurological outcome and weight gain. There are far fewer functional deficits. Animals treated with Viagra days after stroke had a significant reduction in neurological deficit and a significant induction of new brain cells.
"One can be treated with Viagra, erythropoietin, or statins days after stroke and there is a significant reduction in neurological deficit and a significant induction of new brain cells," says Dr. Chopp. Similar studies and successful restoration of neurological function after stroke, trauma, and neurodegenerative disease have been performed by Dr. Chopp and colleagues.
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