Deborah Kalume got off the ladder as the pain in her head increased, followed by dizziness, nausea and a loud sound she thought was tree frogs. As she lay down to rest, she reached up and barely touched an artery in her neck.
"And when I did, the pain in my head went away," she said. "So that's when I knew the noise was related to the pain in my head and that something more serious was going on."
It was a massive stroke, and a year later she still struggles to use her left hand and leg. She got the clotbusting drug tPA, however, and was also just in time to receive an experimental treatment at Medical College of Georgia that is actually an antibiotic commonly used for acne. As with the other participants in the MCG study who got the clot-buster and minocycline, the best part might be what she didn't get -- bleeding in her brain.
The MCG researchers have finished an early phase study on the use of the antibiotic in stroke patients and are now preparing plans for a massive 2,000-patient study that would include many of the stroke centers in Europe. Their findings are published in the journal Stroke .
While it is hard to say conclusively, the researchers hope that the drug can cut down on the size of the damage in the brain and reduce the risk of hemorrhage from tPA.
"If either one of those worked, it would be a big break," said Dr. David Hess, the chairman of the Department of Neurology at MCG and one of the leaders of the minocycline studies. "If you cut the hemorrhage risk in half, then that would take the fear out of using tPA."
The antibiotic is known to reduce levels of matrix metalloproteinase-9, which has been associated with hemorrhage, but it will take the large trial in humans to show whether it really reduces bleeding in the brain, he said.
"It's all plausible that it should reduce hemorrhage, but until we show it in a large clinical trial it's just plausible," Hess said.
Currently, tPA is the only drug approved by the Food and Drug Administration for stroke, so getting a safe drug for stroke, even if it provides only some benefit, would be a plus, said Dr. Susan Fagan, the assistant dean for the University of Georgia College of Pharmacy's MCG program and a leader of the minocycline studies.
"I think you can go with a smaller benefit if it is really safe," she said. "tPA has a big benefit, but it also has the significant side effect of the hemorrhage. I think we are willing to accept it because of the big benefit. We're expecting a more modest benefit with minocycline."
The research at MCG into minocycline as a neuroprotective began earlier this decade in animal studies, and to bring it forward as a "repurposed" potential human drug is gratifying, Fagan said.
"Finishing this first step in the clinical trial process is pretty exciting even though we still have a long way to go to prove it is efficacious," she said.
Kalume also has a long way to go to regain function in her hand and leg, even when she has completed her course of physical therapy at Walton Rehabilitation Hospital. It is especially frustrating for her because she is the mother of 3-year-old quadruplets, and she struggles to help her husband, John, with them. For instance, the children are learning how to defeat the babyproofing.
"We have a big, long baby fence that separates what used to be our living room from the rest of the world," Kalume said. "Of course, they've learned how to scale it. So now the only thing it does is slow me down, not them."
While the benefits of taking minocycline might not be readily apparent for her, she does think it has the potential to good for others down the road.
"There's the psychological effect of being able to help with the study," Kalume said.
Researchers with the Medical College of Georgia and the University of Georgia College of Pharmacy plan to submit a proposal to the National Institutes of Health to test the antibiotic minocycline in up to 2,000 stroke patients as part of an international study. If funded, the earliest it would start is next year, but is more likely to happen the following year, the researchers said.
Many Stroke, Cerebral Palsy, brain and spinal injury patients experience arm and hand movement impairment which makes daily tasks very difficult. Occupational/ Physical therapists have in their hand therapy repertoire several techniques to maintain and improve the patient's finger and wrist movement ability including Neuromuscular stimulation and robot-assisted rehabilitation. Additionally an important component in achieving optimal rehabilitation outcome is intensive active movement practice together with task orientated training. The HandTutor is a biofeedback training glove and software that provides customized games and biofeedback to motivate and challenge the patient to do intensive active finger and wrist exercises and to achieve maximal functional recovery. It can be useed even if the patient has very limited hand movement! It has now been purchased by the Rusk Institute of Rehabilitation Medicine. I hope Walton Rehabilitation Hospital follow soon to allow patients access to the HandTutor which teaches the patient how to move their hand again.
"For instance, the children are learning how to defeat the babyproofing."
Yep, that's what 3 year olds do.
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