Medtronic has enrolled the first patient at Kempenhaeghe-Heeze, the Netherlands, into the MedtrOnic Registry for Epilepsy (MORE) registry to evaluate the long-term efficacy, quality of life impact and safety of deep brain stimulation (DBS) in patients with refractory epilepsy.
The registry will enrol around 200 prospective patients to examine seizure frequency, severity, safety and impact of DBS therapy on a patient's quality of life. DBS therapy uses a surgically implanted medical device, similar to a cardiac pacemaker, to deliver mild electrical pulses to precisely targeted areas of the brain.
MORE, using Medtronic DBS devices, includes three level one studies of DBS for Parkinson's disease, one level one study of DBS for epilepsy and a ten-year follow up study of DBS in Parkinson's disease.
Currently, Medtronic's DBS therapy is approved for use as adjunctive therapy for reducing the frequency of seizures in adults diagnosed with epilepsy characterised by partial-onset seizures, with or without secondary generalisation, that are refractory to antiepileptic medications.
In Europe, Medtronic DBS therapy has been cleared for the treatment of tremor and obsessive compulsive disorder, but is not yet approved by the US Food and Drug Administration for the treatment of refractory epilepsy in the US. Medtronic Neuromodulation division deep brain stimulation business vice president and general manager Lothar Krinke said they continue to collaborate with researchers to advance DBS technology and research next-generation therapies to treat chronic neurological conditions.
Ghent University Hospital, Belgium, Department of Neurology professor Paul Boon said MORE will aid in understanding how electrical stimulation can help patients affected by refractory epilepsy.
"By studying the long-term impact of DBS on the anterior nucleus of the thalamus, we hope to understand even further how seizures can be controlled and reduced," Boon added.
The company's Neuromodulation business includes neurostimulation and implantable, targeted drug delivery systems for the management of chronic pain, common movement disorders, spasticity and urologic and gastrointestinal disorders.
Image: Medtronic World Headquarters, Fridley, Minnesota, US. Photo: Bobak Ha'Eri.