This is BrainsWay’s global website. The website includes information on clinical indications that were not cleared by the FDA and are considered investigational by the U.S. medical device regulations. BrainsWay D treatment is FDA cleared for patients with MDD who failed to respond to one or more anti-depressants in the current episode.
SEATTLE — For many, depression is a serious illness that seems impossible to overcome, but now there’s hope for those who have had no luck with their medication.
A sophisticated helmet is changing people’s lives that has worked for some.
“I lost the feeling of joy for many, many years,” said Jan Webb, who has used the depression helmet.
Webb has battled depression for 35 years and it was something that impacted her entire life.
“It was to the point where all I wanted to do was stay in bed. I was an avid exerciser and I stopped exercising. I stopped being social,” said Webb.
For years she took medications that didn’t work long term. She was hospitalized 5 times and then Webb learned about a different type of treatment.
It’s a helmet-like device that creates stimulation to the brain.
It’s known as deep transcranial magnetic stimulation known as TMS.
Read the full story here.
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Brainsway Deep TMS is indicated by the FDA for the treatment of depressive episodes in adult patients suffering from Major Depressive Disorder, who failed to achieve satisfactory improvement from previous anti-depressant medication treatment in the current episode. FDA 510(k) No. K122288.
Patients should consult with their doctor before undergoing Deep TMS. The most common side effects include headaches and application site pain or discomfort. There is also a very rare risk of seizure associated with the treatment. Patients with metal in or around the head, such as in metal plates, implants and stents, should not undergo Deep TMS treatment.
Deep TMS in randomized controlled trials
In the multicenter trial that led to FDA clearance of the Deep TMS device, 1 in 3 medication-resistant patients treated with Deep TMS achieved remission. (Lefkovitz Y, et al. Efficacy and safety of deep transcranial magnetic stimulation for major depression: a prospective multicenter randomized controlled trial. World Psychiatry 14:64-73 (2015))
In real-life community treatment settings, 20 sessions of Deep TMS produce remission rates even higher than those observed in clinical trials. Among patients who went on to complete a treatment course of 30 sessions, 1 in 2 achieved full remission. (Data on file)