BrainsWay Deep TMS for Major Depressive Disorder
BrainsWay Deep TMS™ uses magnetic fields delivered through an H-Coil helmet to stimulate targeted brain regions involved in depression. It is a non-invasive treatment option with an FDA-cleared indication for adults with Major Depressive Disorder who have not achieved satisfactory improvement with previous antidepressant medication treatment in the current episode.
*Response and remission figures are from a Phase IV real-world analysis of Deep TMS using the H1 Coil and refer to outcomes after 30 sessions. Individual results vary.
#Approximate duration for a standard Deep TMS depression session; protocols and session durations may vary.
Deep TMS® Platform
- Patented H-Coil® technology
- Deep TMS® stimulation
- Multiple FDA-cleared indications
- Accelerated treatment protocols
What Clinical Research Shows
Clinical studies have evaluated BrainsWay Deep TMS for Major Depressive Disorder using standardized measures of symptom response and remission. Outcomes vary by study design, treatment protocol, number of sessions, and how response or remission is measured.
In a Phase IV real-world analysis, 81.6% of participants with available outcome data met criteria for response after 30 sessions.
In the same analysis, 65.3% of participants with available outcome data met criteria for remission after 30 sessions.
A standard depression protocol commonly uses weekday sessions for about four weeks. Treatment schedules vary by protocol and clinical plan.
Source: Tendler et al., Psychiatry Research, 2023. Phase IV real-world analysis of 1,753 patients across 21 sites; 1,351 patients were included in the outcome analysis. These figures do not represent all people who receive BrainsWay Deep TMS.
When can improvement begin? Response to Deep TMS varies from person to person. In the same analysis, the median time to sustained response among those who achieved it was 16 sessions (about 21 days). Some people notice changes earlier or later, and lack of early improvement does not necessarily mean treatment will not help.
What Is Deep TMS?
Deep Transcranial Magnetic Stimulation (Deep TMS™) is a non-invasive brain stimulation technology that uses magnetic pulses to induce electrical activity in targeted brain regions. BrainsWay’s system uses proprietary H-Coil technology integrated into a helmet-like device positioned over the patient’s head.
H-Coil Technology
BrainsWay’s H-Coil is designed to stimulate broader and deeper regions of the brain than conventional figure-8 TMS coils. The coil is housed in a padded helmet positioned over the head during treatment.
MDD and Anxious Depression
BrainsWay Deep TMS is FDA-cleared for depressive episodes, and for decreasing anxiety symptoms, in adults with MDD who have not achieved satisfactory improvement from previous antidepressant medication treatment in the current episode.
Deep TMS for Depression
A commonly used Deep TMS depression protocol involves approximately 20-minute sessions delivered five days per week during the acute phase. Other cleared protocols may use different session schedules or durations.
Explaining Deep TMS Technology
Watch an overview of Deep TMS technology and how the approach is used in the treatment of depression.
Key Features of BrainsWay Deep TMS
Non-invasive Treatment
Deep TMS is delivered without surgery, anesthesia, or sedation. Patients remain awake during treatment.
H-Coil Technology
BrainsWay’s H-Coil technology uses magnetic pulses delivered through a helmet positioned over the head.
No Medication Exposure
Deep TMS does not involve a medication circulating throughout the body. Treatment can still cause side effects such as headache or discomfort at the treatment site.
Structured Treatment Course
A commonly used depression protocol involves weekday sessions during an acute treatment phase. A clinician determines the treatment schedule and whether continuation or maintenance treatment is appropriate.
Safety and Common Side Effects
Deep TMS is generally well tolerated, but side effects can occur. Common effects may include headache, discomfort at the treatment site, and jaw or facial discomfort. Seizures are a rare but recognized potential adverse event.
People considering TMS should discuss potential risks, precautions, and whether the treatment is appropriate with a qualified clinician.
Find a clinic to discuss Deep TMS with a qualified clinicianWho May Be Considered for Deep TMS for MDD?
In the United States, the BrainsWay Deep TMS System is FDA-cleared for the treatment of depressive episodes in adult patients with Major Depressive Disorder who have not achieved satisfactory improvement with previous antidepressant medication treatment in the current episode.
Considerations
Major Depressive Disorder
The FDA-cleared indication applies to depressive episodes in adults with Major Depressive Disorder.
Previous Antidepressant Treatment
The cleared MDD indication specifies that satisfactory improvement was not achieved with previous antidepressant medication treatment in the current episode.
Clinical Evaluation
A qualified clinician determines whether Deep TMS is appropriate after reviewing diagnosis, treatment history, medical history, and relevant safety considerations.
Questions to Discuss With a TMS Clinic
These questions can help you prepare for a conversation with a clinic. They are not a diagnostic or eligibility test.
- Is BrainsWay Deep TMS appropriate for my diagnosis and treatment history?
- Which Deep TMS protocol does the clinic use?
- How many sessions are typically planned?
- What side effects and precautions should I know about?
- How does the clinic monitor progress during treatment?
- What costs or insurance requirements should I understand before starting?
Find BrainsWay Deep TMS Clinics Near You
Explore MDDCare’s directory of clinics that list BrainsWay Deep TMS for depression. Review clinic locations and available information to find options in your area.
BrainsWay Deep TMS™ Availability
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Treatment Modalities
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Location
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Insurance & Coverage
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Directory note: Clinic listings, treatment availability, and insurance information may change. Confirm current details directly with the clinic.
Medical information disclaimer: MDDCare provides general health information and a directory of clinics. Information on this page is not medical advice and does not replace evaluation or advice from a qualified healthcare professional.
Sources: FDA 510(k) K122288 (MDD)FDA 510(k) K203735 (iTBS protocol)Tendler et al., 2023 (Psychiatry Research)BrainsWay: Major Depressive DisorderBrainsWay: Anxious Depression