Brainsway’s Deep TMS EU Cleared for Neuropathic Chronic Pain

Brainsway’s Deep TMS EU Cleared for Neuropathic Chronic Pain

“Neuropathic pain is the sixth indication for which Deep TMS has achieved CE Mark approval,” commented Uzi Sofer, Brainsway’s CEO. “Previous CE Marks were for clinical depression, bi-polar disorder, schizophrenia (negative symptoms), Parkinson’s diseases and post-traumatic stress disorder. As our therapeutic pipeline continues to expand, it is very exciting to continue to bring proven new Deep TMS treatments to market.”

About Brainsway Ltd.

Brainsway is dedicated to the development and marketing of Deep TMS (Transcranial Magnetic Stimluation) 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.

This news release was distributed by GlobeNewswire, www.globenewswire.com

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.

The unique technology of Brainsway Deep TMS System enables direct non-invasive activation of deep brain structures.

Deep TMS is a breakthrough in the search for a non-invasive approach for treating common brain disorders. Deep TMS uses a unique, patented coil design to produce directed electromagnetic fields that can induce excitation or inhibition of neurons deep inside the brain. The treatment is non-invasive, with no significant side effects, no systemic effect (in contrast to drugs), and no need of hospitalization or anesthesia.

If you remember from your high school or college physics classes, there is a strong relationship between electricity and magnetism. Basic principles of electromagnetism have revolutionized the way we live; for example, knowledge that a wire carrying a current generates a magnetic field led to the development of motors and the discovery that moving a magnet through a loop of wire could produce electricity led to the creation of generators.

Deep transcranial magnetic stimulation (TMS) is a medical application of electromagnetic technology. It essentially relies on the fact that neurons communicate via chemical-electric signals; hence, like other electrical signals, neuronal communication should be able to be influenced by external magnetic fields, or pulses.

The Jerusalem-based company Brainsway has been applying deep TMS technology to potentially treat a number of clinical conditions, some of which have been previously reported here in Medgadget, such as depression, attention deficit disorder, and smoking addiction. Now, the company reports initial positive findings in a small trial of Alzheimer’s patients treated with deep TMS.

According to Brainsway’s press release:

The interim results are for 24 patients that were divided into three groups: a sham stimulation control group, a low-frequency (1 Hz) treatment group and a high-frequency (10 Hz) treatment group. Each subject received treatment over 8 weeks, and the efficacy of the treatment was evaluated both during the trial and over the course of the subsequent 8-week period.

The treatment was well-tolerated by all subjects, with no side-effects, except for one incident involving a sham control subject, which the principal investigator believes to be unrelated to the treatment.

The trial used the Alzheimer’s Disease Assessment Scale – Cognitive (ADAS-Cog) test (the main efficacy scale used in Alzheimer’s disease clinical trials), as well as additional accepted scales of disease severity (CGI, ADL, CDR) and a quality-of-life scale (QoL Caregiver Scale) to assess the efficacy of treatment. These are the main assessment scales used to evaluate efficacy in the literature.

Analysis of ADAS-Cog results revealed a 4.2-point improvement in the high-frequency treatment group, compared with a 1.8-point improvement in the sham control group, and a 1.4-point deterioration in the scores of the low-frequency treatment group, the latter occurring mainly during the 8 weeks post treatment. In addition, in the high-frequency treatment group, severity of cognitive impairment at entry into the trial was correlated with clinical improvement (the more severe the cognitive impairment, the more the patient improved following treatment).

CDR, ADL, CGI and QoL Caregiver Scale scores indicated that high-frequency treatment halted the deterioration of the disease and even produced a moderate improvement relative to sham treatment. Similar to the ADAS-Cog test results, these scores also indicated a worsening in the condition of patients treated with low-frequency electromagnetic stimulation.

The principle investigator commented, “The interim results from the trial indicate that Deep TMS therapy for Alzheimer’s disease patients is safe and side-effect-free. Although the small sample size somewhat hampers our ability to draw any definitive conclusions concerning treatment efficacy, the results nonetheless suggest that high-frequency treatment leads to improvement on Alzheimer’s disease assessment scales, whereas low-frequency and sham treatment do not.”

Source : http://www.marketwatch.com/story/brainsway-receives-ce-mark-approval-for-its-deep-tms-system-to-treat-neuropathic-chronic-pain-2012-07-02

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