Brainsway has reported positive final results from a clinical trial investigating the efficacy of a deep transcranial magnetic stimulation (TMS) system to open the blood-brain barrier (BBB) in patients with brain tumours.
Advanced Technologies Innovation Distribution SRL (ATID), in collaboration with Ben-Gurion University and the University of Rome, conducted the study in Italy.
The trial recruited a total of 19 patients with glioblastoma multiforme (GBM) tumours who had undergone surgery more than a year before the trial.
Deep TMS utilises a unique, patented coil design to produce directed electromagnetic fields that can induce excitation or inhibition of neurons deep inside the brain.
TMS is a non-invasive technique of inducing an electric field in the underlying brain tissue, to activate the neurons in the relevant brain structure.
The final results from the study demonstrated that high-intensity deep TMS treatment protocols induced a temporary but considerable degree of BBB opening in ten of the remaining 12 patients (83%), following the REAL stimulation in comparison to the SHAM stimulation, in an area within and around the tumour zone.
In the study, the changes in BBB permeability were measured in each patient by comparing the effects of deep (REAL) TMS stimulation to SHAM stimulation.
The researchers said the new technique will improve the delivery of chemotherapy drugs to brain tumours and even in the treatment of other central nervous system diseases.
One of the principal investigators of the trial, Alon Friedman, said the final results, which support the interim results of the study, attest to a novel non-invasive technique to safely and efficiently open the BBB.
"We, therefore, recommend that a multicentre trial be initiated in patients with GBM and other brain tumours in which the efficacy and safety of this novel method for BBB opening in combination with drug delivery would be investigated," Friedman added.
In November 2011, the company received European approval for the deep TMS device for the treatment of the post traumatic stress disorder (PTSD).
Headquartered in Jerusalem, Israel, Brainsway aims to develop non-invasive medical devices for the treatment of a wide range of neurological and psychopathological disorders.