Brainsway gets Israeli registration in Israel for deep-brain stimulation device to treat depression

Brainsway Ltd. wins Israeli Ministry of Health approval for its non-invasive deep-brain stimulation device, which uses transcranial magnetic stimulation to treat depression, bipolar disorder and schizophrenia.

Brainsway Ltd.'s transcranial magnetic stimulation device won Israeli Ministry of Health approval to treat major depression, bipolar disorder and negative impairment in schizophrenia patients.

The approval clears Jerusalem-based Brainsway to sell the non-invasive TMS device, which delivers brief magnetic pulses to the brain, to four medical centers specializing in mental disorders.

"We are very pleased to receive this vote of confidence in the Deep TMS technology from our homeland's regulatory authority. We are now working to update indications with the Israeli Ministry of Health to bring them more in line with the approvals that we've already received in Europe," CEO Uzi Sofer said in prepared remarks.

Update of the Avery-George-Holtzheimer Database of rTMS Depression Studies

UPDATED as of 05/19/2010; Please direct any feedback to Paul Holtzheimer.

This database has been compiled by David Avery, M.D., Mark George, M.D. and Paul E. Holtzheimer, MD

Download the file"rTMS depression database updated 2010.xls" here.

Deep Transcranial Magnetic Stimulation Gets European Regulatory Approval for Treatment of Depression

Brainsway, a firm building transcranial magnetic stimulation systems (TMS) out of Jerusalem, Israel, just received European approval to market its devices for the treatment of depression. The TMS treatment is likely to be used initially for cases of severe drug resistant depression. But we can envision a day when this technology becomes a mainstream therapeutic option for bipolar disorder and some other psychiatric diseases.

About the technology from Brainsway:

Transcranial magnetic stimulation (TMS) is a noninvasive technique used to apply brief magnetic pulses to the brain. The pulses are administered by passing high currents through an electromagnetic coil placed adjacent to a patient's scalp. The pulses induce an electric field in the underlying brain tissue. When the induced field is above a certain threshold, and is directed in an appropriate orientation relative the brain's neuronal pathways, localized axonal depolarizations are produced, thus activating the neurons in the relevant brain structure.
Standard TMS coils are limited to activation of only cortical brain regions, up to a depth of about 1.5 cm. Hence when treating depression with a standard TMS system, the limbic system, which is related to mood regulation and is generally deeper than 1.5 cm, is only indirectly affected, through secondary processes involving cortical structures, which are directly activated by TMS and then affect the deeper limbic system structures.

A randomized trial of rTMS targeted with MRI based neuro-navigation in treatment-resistant depression

PMID: 19145228
TITLE: A randomized trial of rTMS targeted with MRI based neuro-navigation in treatment-resistant depression.
AUTHORS: Paul B Fitzgerald, Kate Hoy, Susan McQueen, Jerome J Maller, Sally Herring, Rebecca Segrave, Michael Bailey, Greg Been, Jayashri Kulkarni, Zafiris J Daskalakis
AFFILIATION: Alfred Psychiatry Research Centre, The Alfred and Monash University School of Psychology, Psychiatry and Psychological Medicine, Commercial Rd Melbourne, Victoria, Australia. paul.fitzgerald@med.monash.edu.au
REFERENCE: Neuropsychopharmacology 2009 Apr 34(5):1255-62
The aim of this study is to investigate whether repetitive transcranial
magnetic stimulation (rTMS) targeted to a specific site in the
dorsolateral prefrontal cortex (DLPFC), with a neuro-navigational method
based on structural MRI, would be more effective than rTMS applied
using the standard localization technique. Fifty-one patients with
treatment-resistant depression were randomized to receive a 3-week
course (with a potential 1-week extension) of high-frequency (10 Hz)
left-sided rTMS. Thirty trains (5 s duration) were applied daily 5 days
per week at 100% of the resting motor threshold. Treatment was targeted
with either the standard 5 cm technique (n=27) or using a neuro-
navigational approach (n=24). This involved localizing the scalp
location that corresponds to a specific site at the junction of Brodmann
areas 46 and 9 in the DLPFC based on each individual subject's MRI scan
There was an overall significant reduction in the Montgomery-Asberg
Depression Rating Scale scores over the course of the trial, and a
better outcome in the targeted group compared with the standard
localization group at 4 weeks (p=0.02). Significant differences were
also found on secondary outcome variables. The use of neuro-navigational
methods to target a specific DLPFC site appears to enhance response to
rTMS treatment in depression. Further research is required to confirm
this in larger samples, or to establish whether an alternate method
based on surface anatomy, including measurement from motor cortex, can
be substituted for the standard 5 cm method.

Brainsway reports interim results for bi-polar treatment

Participants in the study had not responded to previous drug treatments.
Globes correspondent 5 Jun 08 16:39
Medical device company Brainsway Ltd. (TASE:BRIN) has reported the interim results of the trial of its Deep Transcranial Magnetic Stimulation (TMS) device in the treatment of bio-polar disorder (manic depressive) patients at the Shalvata psychiatric hospital who did not respond to other treatments.
The results showed a satisfactory response among patients who had previously been treated with antidepressants, and who did not report any side effects during the trial. 80% of the patients responded to treatment, with more than 50% reporting a significant improvement, using the various depression measurement scales.

Our fellow weblog Brain Stimulant has an interesting comment on these results.

A Gentler Way to Jump-Start the Brain

Deeply affected: Patients with severe depression may find relief with the help of a wired helmet (above). A magnetic field generated by the helmet harmlessly induces electric currents deep in the brain, giving underactive neurons a much-needed jump start. 

Credit: Brainsway

Scientists in Israel are testing a noninvasive method to electrically stimulate neurons deep in the brain.

An article in Technology Review on Deep Transcranial Magnetic Stimulation.