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.
|Contact: Jason Cody|
Michigan State University