JERUSALEM, Dec. 28, 2011 (GLOBE NEWSWIRE) -- Brainsway Ltd. (TASE:BRIN) is pleased to announce that it has received interim results with respect to 26 patients from a double-blinded clinical trial being conducted at the Charité Hospital in Berlin and at the University Medical Center Hamburg-Eppendorf in Hamburg to assess the safety and efficacy of the Company's Deep TMS device for the treatment of multiple sclerosis (MS) patients.
The trial subjects were divided into three groups: a sham-stimulation control group, a treatment group that received high-frequency (18 Hz) left prefrontal stimulation, and an additional treatment group that received low-frequency (5 Hz) motor cortex stimulation. Each subject received a series of treatments three times per week over a period of six weeks. The effects of the treatment were evaluated over the course of the subsequent six-week period.
The effects of the treatment on subjects' fatigue levels were assessed using standard fatigue rating scales such as the Fatigue Severity Scale (FSS), the Modified Fatigue Impact Scale (MFIS) and the Visual Analogue Scale (VAS); and its effects on subjects' depression levels were assessed using the Hamilton Rating Scale for Depression, the Beck Depression Inventory (BDI) and the Positive and Negative Affect Scale (PANAS).
Analysis of fatigue rating scale results revealed a significant improvement in FSS scores in the motor cortex stimulation treatment group, as well as a tendency towards significant improvement in the left prefrontal stimulation treatment group. A non-significant improvement in VAS scores was observed in the left prefrontal stimulation group, and both treatment groups also displayed non-significant improvement in MFIS scores. The control group showed either no improvement or only non-significant improvement on fatigue rating scales.
As for the treatment's effect on depression, a significant improvement on the BDI and the PANAS was observed in the motor cortex stimulation group, while the other groups' scores on these depression rating scales did not change significantly.
The principle investigator commented, "These results indicate that Deep TMS therapy with Brainsway's device is safe and effective for the treatment of MS patients, and that it may even alleviate these patients' fatigue symptoms. Of note, the treatment's effects on metabolic and neural activity have not yet been investigated, and will be addressed in future studies."
About Brainsway Inc.
Brainsway Ltd. is dedicated to the development and marketing of Deep TMS (Transcranial Magnetic Stimulation) systems--novel, noninvasive medical devices for treatment of a wide range of neurological and psychopathological disorders. In principle, any brain-related disorder that is associated with pathological activity of specific brain sites may be treated by this method. Potential applications include addiction, schizophrenia, obesity, eating disorders, Parkinson's disease, Alzheimer's disease, autism and post-traumatic stress disorder.
Our initial focus is the treatment of major depression. The unique technology of Brainsway is based on patents filed by the U.S. National Institute of Health (NIH) and by the company. Brainsway has an exclusive license from the NIH for the patent and technology. Headquartered in Jerusalem, Israel, the company's ordinary shares and warrants trade on the Tel Aviv Stock Exchange under the symbol 'BRIN.'
Forward-Looking Statements
This press release contains forward-looking statements, which reflect the Company's current expectations regarding future events. The forward-looking statements involve risks and uncertainties. Actual events could differ materially from those projected herein. Investors should consult the Company's ongoing quarterly filings and annual reports for additional information on risks and uncertainties relating to these forward-looking statements. The reader is cautioned not to rely on these forward-looking statements. The Company disclaims any obligation to update these forward-looking statements.