Deep Transcranial Magnetic Stimulation Enables Controlled Opening of Blood-Brain Barrier
Potential for a safe breakthrough methodology of direct medication transfer to the brain for treating brain tumors & other critical conditions
The prestigious Journal of Neuroscience recently published a paper on Brainsway's Deep TMS methodology used for controlled opening of the blood-brain barrier.
The blood-brain barrier is the interface between the central nervous system and the blood system that nourishes it. The barrier regulates the transfer of molecules between the blood and the brain, maintaining a constant environment surrounding the nerve cells to ensure their normal functionality. A controlled opening of the barrier can allow the transfer of substance and medication directly into the brain, enabling breakthrough treatments for a variety of diseases. Until now there was no safe way to achieve this objective.
The research was headed by Professor Alon Friedman from Ben Gurion University, in collaboration with other researchers from Canada and Italy. During the initial phase, researchers used animal subjects to demonstrate how stimulation using Brainsway’s H-Coil, suited for small animals, intensified release of Glutamate, a prevalent neurotransmitter and generated an increase in blood brain barrier penetration.
Later, during a double blind clinical study with 15 participants suffering from Glioblastoma Malforme, an early-stage malignant brain tumor, the researchers used Brainsway Deep TMS for stimulation of the brain around the tumor area. The stimulation effect was examined through MRI procedures performed immediately before and after stimulation with a unique set of parameters, and sham treatment. Each patient received a real stimulation on one day, and a sham stimulation on another day. The order of the stimulation types was selected in a random double blind fashion.
The results showed that unlike sham treatment, the real treatment using Deep TMS caused a temporary, significant and statistically distinct rise in the blood brain penetration in 10 out of 15 patients. The most significant difference between real and sham treatment was found in the area of the tumor, which was the target of the stimulation. However, there was also a rise in the penetration of the blood system in brain areas distant from the tumor– areas which are generally considered to be non-penetrable by chemotherapy, but tend to be a target for spreading tumors. In the process of the research, no side effects were observed.
In summary, the research presents, for the first time, a methodology which can be used to manipulate the blood brain barrier in a safe way, without pain or sedation, to enable penetration of medication directly to the brain. This technique can be used for enhanced penetration of medication for the treatment of brain tumors and other conditions in which the increased efficiency of drug delivery to the brain is expected to lead to significant improvements in clinical outcome.
The information in this report is a description the results of a preliminary experiment in Deep TMS which included a relatively small number of participants. These results do not necessarily point to the effectiveness of Deep TMS for treating the discussed condition and there is no certainty of this, and it is subject to successful completion of additional studies; This could take a long while, and there is no certainty regarding the duration of time required to complete the licensing procedure for the company's device for treating the above mentioned phenomena, and regarding the success of this procedure, and the costs entailed.