MSU is teaming up on a clinical trial in Africa
with Bio-Signal Group, which has created a portable, wireless EEG monitoring
device, called microEEG.
Michigan State University researchers, with
the help of a groundbreaking medical device, are starting a clinical trial in
Africa they hope will provide relief for the hundreds of thousands of children
who survive cerebral malaria but are left stricken with epilepsy or other
neurologic disorders.
The
impact of those disorders via loss of human potential and lack of societal
contribution is immeasurable, said Gretchen Birbeck, a professor of neurology
and ophthalmology in the College of Osteopathic Medicine.
Birbeck
is leading the trial in the central African nation of Malawi that will use levetiracetam, or LVT,
an anti-seizure medication used in the United States and other developed
nations. However, the drug has never been tested to target cerebral malaria
seizures.
"Seizure
management in malaria endemic regions such as sub-Sahara Africa is challenging
because the available antiepileptic drugs can
suppress respiration, and assisted ventilation is unavailable," Birbeck
said. "LVT does not have that effect, and if we can optimize a seizure
control treatment that is both affordable and accessible in resource-limited
settings, we may be able to improve neurologic outcomes in cerebral malaria
survivors."
The
research, part of MSU's Blantyre Malaria Project at Queen Elizabeth Central
Hospital, is being funded with a nearly $2 million grant from the National
Institutes of Health's National Institute of Neurological Disorders and Stroke.
Cerebral
malaria is a severe form of malaria affecting the brain, occurring
predominantly in children, with a mortality rate of 15-25 percent. It affects
about three million children every year, primarily in sub-Saharan Africa.
Almost
a third of cerebral malaria survivors develop epilepsy or otherneurologic disorders,
according to research Birbeck – also director of MSU's International Neurologic
& Psychiatric Epidemiology Program – published previously in The Lancet
Neurology.
The new
clinical trial will test the safety and feasibility of LVT to control seizures
in children specifically with cerebral malaria. Instead of delivering the drug
intravenously, which is too costly for most developing nations such as Malawi,
it will be given via a tube in the nasal passage, an effective method in
hospitals and clinics that lack resources.
About
40 children will be selected for the trial. If all safety standards are met,
dosage will be increased until 75 percent of children are free of seizures for
24 hours (typically, only 20 percent of children admitted with cerebral malaria
and seizures are seizure free in the first 24 hours).
To
accurately test whether children are staying seizure free, MSU is collaborating
with New York-based biotechnology firm Bio-Signal Group, which has created a
portable, wireless EEG monitoring device, called microEEG that can accommodate
up to 32 electrodes and connects via Bluetooth technology to a small monitoring
machine.
"Unfortunately,
many children who survive malaria continue to have seizures with no physical symptoms,
but their brains still are being damaged," Birbeck said. "To evaluate
the effectiveness of LVT, we need continuous EEG monitoring, which is very
tough to do even in the best environment."
Bio-Signal's
microEEG features a monitor the size of a deck of cards that can be worn on the
arm, with a collection of wires going to the electrodes on the child's head.
The monitor then transfers data in real-time to a computer, where it quickly
can be analyzed and shared with colleagues.
"This
state-of-the-art technology, which we believe can be used effectively in our
resource-limited setting, allows us to conduct this trial," Birbeck said.
If the
clinical trial shows LVT can be safe and potentially effective for seizure control in cerebral malaria,
Birbeck and her team will proceed with a phase III randomized clinical trial.
"Since
LVT is relatively affordable for short-term use and feasibly could be delivered
in resource-limited settings, this therapy could potentially be scaled up for
broad use throughout malaria endemic African countries," she said.
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