Aleva Neurotherapeutics Announces Promising Clinical Data30.05.2013 10:32
Aleva Neurotherapeutics, a company developing next-generation implants for Deep Brain Stimulation (DBS) in major neurological indications such as Parkinson´s disease or depression, today announced interim clinical data of an interventional, intraoperative pilot study of its novel directSTIM electrode.
In the ongoing pilot study, clinical investigators assessed the intraoperative clinical effect of directional stimulation using the directSTIM lead. It features two rings consisting of three independent electrodes each. The angular position of the electrodes allows stimulation at 0°, 120° and 240° directions. After assessment, directSTIM was removed and replaced by a classical, ring-shaped permanent DBS lead.
Claudio Pollo, MD, Head of Functional Neurosurgery at the University Hospital, Bern, Switzerland and Principal Investigator of the study, comments on the results of the study: “This is a real breakthrough in the field of DBS. At present, DBS is carried out using ring-shaped electrodes. This intraoperative study is the first to investigate the proof-of-concept of directional stimulation in humans. The results suggests that directional stimulation is more selective for beneficial effects while avoiding side effects. Moreover, the observed side effects were consistent with what we expected given the anatomical structures surrounding the stimulated area.”
The data reported in Tokyo are based on 5 males with Parkinson Disease, which underwent Subthalamic Nucleus (STN) DBS, and 2 males with essential tremor, which underwent Ventral Intermediate Nucleus of the Thalamus (Vim) DBS. Directional stimulation was tested at the target determined for the permanent lead. The clinical investigators compared the therapeutic window (TW, defined as the electrical current threshold at which side effects occur minus the current threshold at which a significant therapeutic effect is observed) of directional and classical stimulation. Directional stimulation resulted in an improved therapeutic window in five of six patients (the ratio could not be measured in one of seven patients). No adverse event took place.
“We are very pleased with the data, as we have proof-of-concept in an intraoperative setting that directional stimulation is measurable and that it is different from classical stimulation,“ said Jean-Pierre Rosat, CEO of Aleva Neurotherapeutics. “This is very promising as it indicates that the effectiveness of DBS may be improved by our novel electrodes.”
About Aleva Neurotherapeutics
The company, based in Lausanne and founded in 2008, is a spin-off from the Ecole Polytechnique Fédérale de Lausanne (EPFL) Microsystems Laboratory of Prof. Philippe Renaud. Aleva Neurotherapeutics has raised EUR 12.8 million from renowned private and institutional investors, among them BioMedInvest AG, BB Biotech Ventures LP, Banexi Ventures Partners, Initiative Capital Romandie and selected private investors.