US-based Electrical Geodesics (EGI) has received an investigational device exemption (IDE) from US Food and Drug Administration (FDA) to conduct clinical trials of its Geodesic Transcranial Electrical Neuromodulation (GTEN) device as a treatment for managing epilepsy.
The trials are designed to show the safety and feasibility of GTEN neuromodulation device in the management of epilepsy.
Designed to evaluate and treat 20 patients, the initial trial in epilepsy is planned to be conducted at two centres, Harborview Hospital at Washington University and at the company’s own facility in Eugene under the direction of an external neurologist.
Following completion and based on results, the company will investigate routes to conduct pivotal studies and move towards clinical approval.
The FDA’s IDE enables the investigational device to be used in a clinical trial in order to collect safety and effectiveness data required to support a premarket notification or 510(k) submission.
GTEN is the latest development of the company’s GES 400 dense-array EEG platform, and will use its advanced head modelling technologies to understand areas of the brain where treatment should be focused.
The device delivers small amounts of highly targeted electrical current through a changing pattern of the device’s 256 electrodes to direct treatment to the focal area and spare treatment to non-target areas.
The company said during and after treatment the same device and electrodes can record brain activity to monitor safety and effects of the product.
Epilepsy is a life-threatening and debilitating condition where more than 25% of patients are drug refractory or resistant, where seizures result from electrical discharges, which frequently derive from a single source of abnormal or damaged brain tissue.
Most brain neuromodulation devices are contraindicated in epilepsy, as seizures might be induced rather than modulated or reduced.
According to research, well-directed magnetic or electrical stimulation can reduce the incidence of interictal spikes.