MDD is a common disabling mood disorder with prevalence of above 8% in the US, making it one of the largest public health challenges.The current standard of care available for MDD patients in the US can be seen as unsatisfactory.

The REACH-tDCS Study is designed to test the safety and effectiveness of the Sooma 2GEN transcranial direct current stimulation (tDCS) system for treating Major Depressive Disorder (MDD). This treatment is done by the patient at home, with guidance and support from the study team through remote supervision and additional resources provided with the device shipment such as the User Manual and Quick Start Guide. All study activities will be conducted remotely via video call with the study team or self-completed by participants on their mobile device.

Participants will be assigned to receive either active tDCS or sham tDCS over a 10-week period. Neither you nor the study team will know which group you are assigned to. No matter which treatment group you are in, you will complete daily 30-minute tDCS sessions for the first 3 weeks, followed by three 30-minute sessions per week for 7 weeks. After this, there’s an optional 10-week follow-up phase where everyone can receive active treatment.