Sleep-to-Mood in Depression: Home-based tDCS

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Adults with moderate major depressive disorder will self-administer transcranial direct current stimulation at home for 20 sessions. Sleep will be continuously tracked with an Oura Ring to measure duration, efficiency, awakenings, and consistency, while depressive symptoms are monitored over time with validated measures. The study aims to see if changes in sleep consolidation occur during treatment and whether those sleep changes align with improvements in depressive symptoms. It will help characterize the relationship between sleep and depressive response during tDCS and may identify sleep-related markers of clinical benefit.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Ability to read and understand study materials in English, as demonstrated by a standard score \>85 on the WRAT-5 Reading Recognition Subtest
2. MADRS-S ≥18 during screening
3. Confirmed diagnosis of MDD, based on clinician interview
4. If taking antidepressant medication, the dose must be stable for at least 30 days prior to pre-screening.
5. Confirmed access to a local provider that has primary responsibility for the subjects' clinical care, and who is available for contact in case of increased subject risk due to depressive symptoms OR confirmed acknowledgement and identification of local resources.
6. Able to provide informed consent and comply with study procedures.
7. Access to a quiet space suitable for home-based tDCS stimulation sessions.

Exclusion Criteria:

1. Current major medical condition that, in the opinion of the study clinician, would interfere with study participation, safety, or interpretation of study outcomes.
2. Current or past bipolar disorder, psychotic disorder, or current (past 6 months) alcohol or substance use disorder, as determined by clinician assessment at screening.
3. Clinically significant suicidal ideation or behavior, based on clinician assessment and the Columbia-Suicide Severity Rating Scale (C-SSRS).
4. Use of prescription or over-the-counter sleep-promoting medications or initiation of behavioral interventions specifically targeting sleep in the past 30 days from pre-screening.
5. History of seizure disorder or epilepsy.
6. Presence of an active implanted medical device above the neck (e.g., deep brain stimulator, cochlear implant) or non-MRI-compatible metallic implants in the head or neck region.
7. Current use of prescription or over-the-counter sleep medications, or active participation in any behavioral or pharmacologic treatment specifically targeting sleep.
8. Pregnancy and Breastfeeding: Currently pregnant, planning pregnancy during the study period, or breastfeeding o If able to become pregnant, participants will be required to use medically accepted birth control methods, including hormonal methods (e.g., pills, patches, implants), barrier methods (e.g., condoms or diaphragm with spermicide), intrauterine device (IUD), or abstinence. Participants will be advised not to become pregnant during the study.

Where it's running

• NYU Langone Health
  New York, New York, United States Recruiting

Study contacts

• Principal investigator: Giuseppina Pilloni — NYU Langone Health
• Study coordinator: Shayna Pehel
• Email: Shayna.Pehel@nyulangone.org
• Phone: 929-455-5104

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.