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What is BrainsWay® TMS Study?

BrainsWay® is a global medical company that specializes in developing cutting-edge medical devices that help advance the field of mental healthcare. The BrainsWay® TMS study refers to an FDA-approved non-invasive treatment procedure conducted using BrainsWay®’s Deep Transcranial Magnetic Stimulation (Deep TMS) technology. The procedure involves utilizing magnetic pulses to stimulate nerve cells in the brain to improve symptoms of a number of mental health/neuropsychiatric conditions. It is called a "noninvasive" procedure because it is performed without using surgery or cutting the skin.

Indications for BrainsWay® TMS Study

BrainsWay® TMS study is typically recommended to treat depression when many of those seeking depression treatment has not received a positive response from the different antidepressant medications or they have to deal with undesirable side effects. Based on the available data, the success rate of BrainsWay®’s TMS therapy stands between 70% and 80%, meaning that most individuals who undergo treatment experience significant relief after the treatment. Approximately 50% of individuals go into full remission, meaning they become completely asymptomatic after one treatment routine.

BrainsWay® TMS study has also been approved to treat other conditions such as obsessive-compulsive disorder (OCD), migraines, and smoking addiction when standard treatments such as medications have been ineffective. When used for depression, OCD, and smoking cessation, this treatment involves delivering repeated magnetic pulses, so it is also called repetitive TMS or rTMS.

Preparation for BrainsWay® TMS Study

Preparation typically involves screening the participants to ensure they meet the study's inclusion criteria. This may involve assessments of their medical history, current health status, and the specific condition being studied, such as depression, obsessive-compulsive disorder (OCD), or other neurological or psychiatric disorders. Before the actual treatment begins, participants undergo baseline assessments to establish their initial condition. This may include psychological evaluations, symptom severity assessments, and neuroimaging scans to measure brain activity. You should also tell your healthcare provider other details, such as if you are pregnant or planning to become pregnant, if you have metal or implanted medical devices in your body, current medication list, or any other medical conditions you may have.

What Happens During BrainsWay® TMS Study?

During the BrainsWay® TMS study, you will be taken to the treatment room, asked to sit in a reclining chair, and provided with earplugs to wear during the procedure. A specialized helmet or electromagnetic coil is placed over the head to deliver magnetic pulses to specific areas of the brain associated with the targeted condition. The frequency, intensity, and duration of the TMS sessions are determined based on the study design. Throughout the study, researchers collect data on your response to treatment, including changes in symptoms, mood, cognitive function, and potentially neuroimaging data to assess brain activity. This data is then analyzed to evaluate the effectiveness of BrainsWay®'s TMS technology for the targeted condition. Patients remain awake during the treatment and can return to normal activities, such as driving, immediately following the session.

Outcome Analysis

If BrainsWay® TMS therapy works for you, your depression symptoms or other conditions that you have sought treatment for may improve or go away completely. Symptom relief may take a few weeks of treatment.

Side Effects

Generally, the BrainsWay® TMS study is considered safe and well-tolerated. However, it can cause some side effects, such as:

  • Headache
  • Scalp discomfort and pain
  • Lightheadedness
  • Spasms, twitching, or tingling of facial muscles

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For informational purposes only, a link to the federal Centers for Medicare and Medicaid Services (CMS) Open Payments web page is provided here. The federal Physician Payments Sunshine Act requires that detailed information about payment and other payments of value worth over ten dollars ($10) from manufacturers of drugs, medical devices, and biologics to physicians and teaching hospitals be made available to the public.

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