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 our research staff 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 35 daily tDCS sessions followed by a maintenance phase involving 18 tDCS sessions. Treatment sessions will be daily for the first 7 weeks (5 days per week – Monday through Friday) and then thrice per week tDCS treatments for the next 6 weeks (3 day per week). At each treatment session, you will be asked to complete brief questionnaires about your mood and overall well-being. After the treatments are over, you will be asked to complete weekly follow-up mood assessments.

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:

• 22 years of age 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
• Treatment resistant depression as defined by inadequate clinical response to 2 or more antidepressant treatments

Final eligibility will be confirmed by the research staff.

If you qualify to participate:

• A study doctor and clinical study team will closely monitor you and your symptoms
• 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

As part of the study, you will receive up to 53 at-home guided tDCS treatments through virtual health portal. You will be loaned all tDCS equipment to complete the study including a home stimulator with stimulation accessories.

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?

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, confirm that they will be available to you for any of your acute care needs for 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 research 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 13-week study. If you are enrolled in the study, you will complete daily tDCS treatments for the first 7 weeks (5 days per week – Monday through Friday) and then thrice per week tDCS treatments for the next 6 weeks (3 day per week). In total, you will receive 353 tDCS sessions with each session lasting about 30 minutes. At each session, research staff 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.

Who is sponsoring this study?

Soterix Medical Inc. is sponsoring the tDCS-LTE Depression Study.

Share This Information:

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.