NeuroStar TMS Therapy has been demonstrated to be safe and tolerable.
Over 10,000 active treatments were safely performed with NeuroStar TMS Therapy during the clinical trials. No side effects such as weight gain, sexual problems, stomach problems, sleepiness, or dry mouth were seen during trials, and there were no negative effects on memory or ability to concentrate.
The most commonly reported side effect related to treatment was scalp pain or discomfort during the treatment session. This side effect was generally mild to moderate, and occurred less frequently after the first week of treatment. Less than 5% of patients treated with NeuroStar TMS Therapy discontinued treatment due to side effects.
NeuroStar TMS Therapy has been demonstrated to be effective in Major Depressive Disorder. Efficacy was established in a controlled clinical trial comparing active treatment with the NeuroStar TMS Therapy system to an inactive device. Patients treated with active NeuroStar TMS Therapy experienced an average reduction in their depression symptom score of 22.1% compared to a 9% average reduction in patients receiving inactive treatment. NeuroStar-treated patients also experienced significant improvement in anxiety, appetite changes, aches and pains and lack of energy associated with depression.
In an open label trial, which is most like a real world clinical practice, approximately 1 out of 2 patients treated with NeuroStar TMS Therapy experienced significant improvement in depression symptoms. Approximately 1 out of 3 patients treated with NeuroStar TMS Therapy experienced complete symptom relief at the end of six weeks. As with any antidepressant treatment, patients should be monitored for symptoms of worsening depression.
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