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Clinical trial for new brain stimulation therapy starts

22 April, 2004

Clinical trials are due to start in the United States of the Intercept Epilepsy Control System, which its developers, Medtronic, hope may reduce seizure rates in patients with epilepsy.

The
trial uses existing technology to test whether stimulation of the
anterior nucleus of the thalamus area of the brain can safely and
effectively reduce seizure frequency in patients with epilepsy. The
trial involves 124 patients who will be implanted and monitored for 13
months following implant, with long-term follow-up until the device is
approved. Patients in the active group, who will receive
neuro-stimulation, will be monitored for a reduction in seizure rates
compared to the control group, who will not receive neuro-stimulation
in the first part of the study.

The
therapy is designed to disrupt the circuits suspected of influencing
epileptic seizures. The system provides bilateral brain stimulation
using three implantable components: a neuro-stimulator (implanted in
the chest), extensions (two small, insulated wires that are threaded
from the neuro-stimulator to the head) and leads (electrodes that are
implanted in the thalamus). The neuro-stimulator generates electrical
pulses that are delivered directly to the brain by the extensions and
leads. These pulses can be non-invasively adjusted by a doctor.

Robert Fisher, professor of neurology and director of Stanford Epilepsy Center at Stanford University, said:

'Pilot studies have been encouraging and this clinical trial, if
successful, will introduce a welcome new treatment for this unmet
medical need.'

In
addition to the ongoing pre-programmed stimulation, patients can
activate additional stimulation when they sense an oncoming seizure by
using a hand-held remote control-style device.