Moss Rehabilitation Research Institute (MRRI), Philadelphia, launched a research study to investigate how the sleep drug zolpidem might restore consciousness for patients in the vegetative state.
The new research study led by John Whyte, MD, PhD, director of MRRI, is the largest and most rigorously designed study to date to examine zolpidem as a possibility for patients with disorders of consciousness.
The condition known as the vegetative state occurs after severe brain injury. Some patients in the vegetative state remain permanently unconscious for which no proven treatment exists.
The new research project was inspired by encouraging results from an earlier study that demonstrated zolpidem can restore consciousness to patients who have been in the vegetative state for several years.
“For medical research, this study enables us to look more closely at whether there is a part of the brain that has the ability to allow a person in a vegetative state to regain consciousness and start functioning again,” said Whyte. “For caregivers of patients whose vegetative states were deemed permanent, this research may offer hope and a way to reconnect with loved ones.”
Based on reports of “miraculous” results among patients with prolonged unconsciousness, Whyte and his team initially conducted a small pilot study of 15 individuals. Among the study participants was a male patient in his 20s who had been rendered unconscious as a result of a car accident 4 years earlier. The patient could open and close his eyes and move his limbs, but showed no real awareness of things around him and only stared vacantly. Whyte and his team administered zolpidem to this patient, and after a single dose of the drug, but not after an identical appearing placebo, the patient was able to respond to commands to move his leg, and was observed to follow other people’s movements with his eyes and even wave goodbye. Other participants of the study showed no such effects.
The new federally funded MRRI study will be conducted over 3 years and seeks to enroll about 100 patients from across the United States who are in a vegetative or minimally conscious state due to brain injury. The study will examine how people respond to the drug, why the drug has a dramatic effect on some patients but not others, and how the drug is working. The researchers theorize that the drug may turn off brain cells that are preventing other parts of the brain from working.
The study is actively seeking participants.
