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H-coil dTMS · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| depressive patients | EXPERIMENTAL | patients suffering from deppresion |
| Name | Type | Description |
|---|---|---|
| H-coil dTMS | DEVICE | treatment with deep TMS stimulation. |
Inclusion Criteria: * MDD patients Exclusion Criteria: * risk factors for convulsions
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H-coil dTMS is an investigational device being studied for the treatment of Major Depressive Disorder (MDD). It is a form of transcranial magnetic stimulation that uses an H-coil to deliver deep brain stimulation. The device is currently in Phase 2 clinical development and has not been approved by regulatory authorities.
H-coil dTMS is developed by BrainsWay Ltd., a company traded on the stock exchange under the ticker BWAY. BrainsWay is focused on non-invasive treatments for brain disorders. The company is conducting clinical trials to evaluate the safety and feasibility of H-coil dTMS for patients with Major Depressive Disorder.
H-coil dTMS is in Phase 2 clinical development. It is an investigational device, meaning it has not yet received regulatory approval. A Phase 2 study has been completed to assess its safety and feasibility in treating Major Depressive Disorder. Further clinical trials would be needed to establish its efficacy and safety for potential approval.
H-coil dTMS has one completed clinical trial registered as NCT00807105. This Phase 2 study, titled 'Evaluation of the H-coil Transcranial Magnetic Stimulation TMS Device - Safety and Feasibility Study for Acute and Maintenance Treatment in Major Depressive Episode,' enrolled 29 participants in Israel. The trial was uncontrolled, meaning there was no control group.
H-coil dTMS is not FDA approved. It is an investigational device currently in Phase 2 clinical development for Major Depressive Disorder. The completed trial (NCT00807105) was a safety and feasibility study, and additional clinical data would be required to support a regulatory submission for approval.