About the Study

The purpose of this study is to analyze depression outcomes for patients with unipolar depression following treatment with a non-drug non-invasive medical device called tDCS-LTE. Entirely in the comfort of your own home, you will be guided through a web-interface by staff at NYU Langone Health medical center through a daily 30-minute treatment session. During each session you will receive brain stimulation using a wearable brain stimulation device called tDCS-LTE with audio-guided mindfulness meditation. Study personnel will assist you at each session and will be available to address any questions or concerns.

If you are enrolled in the study, you will receive 32 daily tDCS sessions for a total of 10 weeks of treatment. Treatment sessions will be daily for the first 6 weeks (5 days per week – Monday through Friday) and then once per week tDCS treatments for the next 4 weeks (1 day per week). At each treatment session, you will be asked to complete brief questionaries about your mood and over all well-being. After the treatments are over, you will be asked to complete weekly follow-up mood assessments.

If you were previously a candidate for FDA approved in-clinic rTMS (repetitive Transcranial Magnetic Stimulation) and ECT (electroconvulsive therapy) you may be eligible to participate in this home-based study.

All treatments and assessments are conducted from the comfort of your home. No in-person visits are needed. Everything you need will be mailed to you.

How to Qualify

You may be eligible if you:

• 18 years or older
• Currently experiencing a current major depressive episode of at least 4 week’s duration as part of unipolar depression

You will not be eligible if you:

• Have a metal in the cranium or skull defects
• Have an implanted pump, neurostimulator, cardiac pacemaker, or defibrillator
• Are pregnant

Final eligibility will be confirmed by the NYU Langone study team.

If you qualify to participate:

• A study doctor and clinical study team will closely monitor you and your symptoms
• You may be referred to additional services through NYU Langone as needed
• If you are currently taking antidepressants you may be able to stay on your current depression medication during the study

Frequently Asked Questions

This section will help answer some important questions you may have

Participation requirement

NYU Langone Health is one of the nation’s premier academic medical centers with more than 4000 doctors and 600 locations and programs, including telemedicine. To qualify for this study you will be enrolled in a NYU Langone Department of Neurology virtual health care program. As part of the program, you will be provided a host of services including psychiatric evaluation and depression assessments, and receive up to 40 at-home guided tDCS treatments through the NYU Langone virtual health portal. You be loaned all tDCS equipment to complete the study including a home stimulator with stimulation accessories. For subjects enrolled in this study, total cost for these included NYU Langone Health services is subsidized to $500*.

Is my participation voluntary?

Yes, your participation in any clinical treatment study is completely voluntary. If you decide to participate, you are always free to withdraw at any time for any reason without any penalty or effect on your future medical care.

Will I have to pay for anything if I choose to participate?

To qualify for this study you will be enrolled in a NYU Langone Department of Neurology telemedicine care program. You will receive a range of planned services through this program related to your care. For subjects enrolled in this study, total cost for these NYU Langone Health services is subsidized to $500*. You do not need to pay for any equipment provided to you through the tDCS-LTE Depression Studies.

Will my personal information be kept private?

The information you provide will not be shared with anyone who is not directly associated with this clinical study without your permission (except as required by law) or as set forth in the informed consent.

Does my doctor need to give me permission to participate?

No, your doctor doesn’t have to give you permission to participate. However, you must have a local physician who is providing you with care for your depression and to document that your depression has been resistant to treatment. In addition, this provider will need to be available to you for any of your acute care needs during the course of the study.

What can I expect if I participate?

The tDCS-LTE Depression Studies include a Screening Period, Treatment Period, and Follow-up Period. All these procedures can be done in the comfort of your own home. The entire tDCS-LTE for Depression program is contactless. Everything you need will be mailed to you. And you will be supported through every step.

Screening Period: The purpose of the Screening Period is to determine if you meet the requirements to take part in the study. You will answer questions from NYU Langone Health staff about your health and symptoms. They will answer any question you have. The study doctor will meet with you and review your information to determine your eligibility for the study.

Treatment Period: If you qualify and decide to enroll in the study, all the equipment and supplies you need will be sent to your home. Through a web-site interface you will be guided through every step of the process and can ask any additional questions. You will complete various questionnaires and tests to help the study doctor evaluate your health and symptoms.

This is a 30-week study. If you are enrolled in the study, you will complete daily tDCS treatments for the first 6 weeks (5 days per week – Monday through Friday) and then once per week tDCS treatments for the next 4 weeks (1 day per week). In total, you will receive 32 tDCS sessions in 10 weeks with each session lasting about 30 minutes. At each session, an NYU Langone team member will connect with you through secured videoconference using the virtual health portal. You will be guided to complete brief questionnaires through the web-portal and then cleared to receive your treatment for the day. During the session, you will be able to contact study personnel with any questions or concerns.

Follow-up Period: After the Treatment Period, NYU Langone Health staff will check in with you 8 weeks and 20 weeks after you complete the treatment period.

Who is sponsoring this study?

Soterix Medical Inc. is sponsoring the tDCS-LTE Depression Study. tDCS-LTE Depression Studies are provided to you through NYU Langone Health.

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* Any payments will be made directly to NYU Langone Health for services that you are receiving. Some reimbursements for research participants will depend on study completion.

If you need immediate help, or you feel you may harm yourself, please dial 911 or your local emergency number. You can also call the National Suicide Prevention Lifeline, 1-800-273-8255, available 24 hours a day.