Brainsway has received the final results of a trial performed by Advanced Technologies Innovation Distribution (AFID) in Italy to explore the efficacy of deep TMS in the opening of the blood-brain barrier (BBB) in patients with brain tumours. The study was conducted as part of a collaboration between Ben-Gurion University and the University of Rome.
A total of 19 patients with glioblastoma multiforme (GBM) tumours were recruited for the study. All of these patients had undergone surgery more than a year before the trial. The data from three patients were excluded due to technical problems, while in four other subjects the limited size of post-resection tumour prevented analysis. In addition four subjects with no tumours were also recruited to serve as a control group. The final results indicated that high-intensity deep TMS treatment protocols induced a temporary, but significant, degree of BBB opening in ten of the remaining 12 patients (83 per cent), following the real stimulation in comparison to sham stimulation, in an area within and around the tumour zone.
BBB opening was observed in patients immediately following the stimulation protocol, which included magnetic field intensities higher than those used in other deep TMS trials, and was quantified using MRI and special protocols for BBB permeability measurement developed at the Zlotowski Centre for Neuroscience at Ben-Gurion University. The changes in BBB permeability were measured in each patient by comparing the effects of deep (real) TMS stimulation to sham stimulation. In the control group, no significant changes in the BBB permeability were observed in the brain following real stimulation in comparison to sham stimulation. No adverse events following the stimulation were observed in any of the subjects in the study.
The opening of the BBB is temporary and it is thought that timing this transient opening to coincide with drug-delivery could focus and enhance drug-delivery, thereby increasing the effectiveness of existing drugs. The researchers hope that this new method will prove effective in enhancing delivery of chemotherapy drugs to brain tumours, including in the treatment of other central nervous system diseases. The prospect of timed opening of the BBB also opens possibilities for the development of new and/or hitherto impractical drugs.
Following completion of the study, the AFID research team have recommended work begin on a multicentre trial in patients with GBM and other brain tumours in which the efficacy and safety of this method for BBB opening in combination with drug-delivery would be investigated. At the same time, animal experiments are being carried out at Ben-Gurion University in order to further characterise the method and its potential mechanisms.