Aleva Neurotherapeutics, a company developing next-generation implants for Deep Brain Stimulation (DBS) in major neurological indications such as Parkinson´s disease, has announced the publication of the results of an intraoperative study with its novel directSTIM™ directional lead. Data were published in the peer-reviewed journal Brain - A Journal of Neurology.
The data presented in Brain are based on 11 patients with Parkinson´s Disease and 2 patients with essential tremor. In the study, clinical investigators assessed the intraoperative clinical effect of directional stimulation using Aleva's directSTIM™ lead. This device features two rings consisting of three independent electrodes each. The angular position of the electrodes allows stimulation at 0°, 120° and 240° directions Directional stimulation was tested at the target determined for the permanent lead. The clinical investigators compared the therapeutic window (defined as the electrical current at which side-effects occur minus the current at which a significant therapeutic effect is observed) of directional and classical stimulation. Compared to omnidirectional stimulation, the therapeutic window in the best direction was 41% wider. Furthermore, the current threshold producing meaningful therapeutic effects in the best direction was 43% lower than in omnidirectional stimulation. No complication was observed due to the insertion and removal of the directional lead or during testing.
"Side effects are often limiting the delivery of adequate current necessary to reach the maximum benefit of DBS," said Dr. Claudio Pollo, Head of Functional Neurosurgery at the University Hospital in Bern, Switzerland and Principal Investigator of the study. "Our data demonstrate that directional stimulation with the directSTIM™ lead has a strong potential to reduce side effects, widen the therapeutic window, and lower the therapeutic current. This new approach may pave the way for improved DBS by increasing the selectivity of stimulation and by prolonging battery life. Furthermore, it provides an access to even smaller and complex regions that are difficult to stimulate with the currently available electrodes."
Alain Dransart, Aleva's Clinical and Regulatory Director, commented: "We are very pleased with the results of this intraoperative study with our directional DBS lead. This is a major milestone for our company. Our next step is the validation of directSTIM™ for long-term implantation so that we can offer this new device to patients suffering from Parkinson´s Disease and essential tremor."