Docs say could be boon for epilepsy patients; ROSE trials at AIIMS,VIMHANS to study radiosurgery versus open surgery
Seven epilepsy patients at AIIMS have been recruited as participants in a 19-centre international study to investigate new treatment regimens as alternatives to existing norms of anti-epileptic medication.
Funded by the research wing of the US Department of Health,the Radiosurgery or Open Surgery for Epilepsy(ROSE) trial is pioneered by doctors from the University of California,San Francisco.
VIMHANS,also in New Delhi,is the other Indian centre joining the trial. The two centres have been registered with the Clinical Trials Registry of India.
Dr S S Kale,Professor of Neurosurgery at AIIMS,said: Epilepsy management is largely dependent on anti-convulsant medicines that control seizures,but have lots of side effects,and often cannot manage the seizures completely. Some specialists are also trying open brain surgeries to remove the seizure focus in the brain. But this goes with all the risks of an open-brain procedure.
This interventional trial is trying to explore the benefits of a new procedure radiosurgery,or minimally invasive surgery through focused radiation,that damages the seizure focus instead of surgically removing it. With no requirement of hospital stay or critical procedures associated with surgery like craniotomy temporary removal of a bone flap in the skull to access the brain this treatment,if successful,will be a boon for epilepsy patients.
Dr Kale said: We plan to enrol up to 30 participants in our centre over the next two years. If proved effective,this will provide relief to epilepsy patients without the side effects of medication,or the risks of open surgeries.
Fourteen centres in the US,two in UK and one in Canada are the other participants.
The main study hypothesis of the ROSE trial is that radiosurgery,which requires no hospital stay,is as safe and effective as open surgery in treating patients with seizures arising from the medial temporal lobe. This study will compare advantages and disadvantages of open surgery versus radiosurgery, states the ROSE website of the US National Institutes of Health.
The primary outcome of the study is freedom from seizures,which will be proved by demonstrating that the 3-year seizure-free rate of radiosurgery is not inferior to that of temporal lobectomy (surgery) between 24 and 36 months following treatment. The second part of the study will try to prove that verbal memory,controlled by the temporal lobe of the brain,will be better controlled by radiosurgery than lobectomy.
Patients who are diagnosed with epilepsy in the temporal lobe,and who are above 18 years of age,are eligible for the trial. Pregnant women,and those suffering from lifestyle disorders like diabetes,are excluded from the trial due to radiation risk.