tDCS: Sleep to Mood in Depression (S2M-D) (NCT07572526) | Clinical Trial Compass
RecruitingNot Applicable
tDCS: Sleep to Mood in Depression (S2M-D)
United States35 participantsStarted 2026-06-04
Plain-language summary
The purpose of this study is to determine whether changes in sleep consolidation occur during home-based transcranial direct current stimulation (tDCS) in adults with moderate depression and whether these changes are temporally associated with improvements in depressive symptoms.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Ability to read and understand study materials in English, as demonstrated by a standard score \>85 on the WRAT-5 Reading Recognition Subtest
. MADRS-S ≥18 during screening
. Confirmed diagnosis of MDD, based on clinician interview
. If taking antidepressant medication, the dose must be stable for at least 30 days prior to pre-screening.
. 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.
. Able to provide informed consent and comply with study procedures.
. Access to a quiet space suitable for home-based tDCS stimulation sessions.
Exclusion criteria
. Current major medical condition that, in the opinion of the study clinician, would interfere with study participation, safety, or interpretation of study outcomes.
. Current or past bipolar disorder, psychotic disorder, or current (past 6 months) alcohol or substance use disorder, as determined by clinician assessment at screening.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is focused on measuring changes in sleep efficiency — does my current sleep pattern fit the kind of profile they're looking for, and could that be part of why my depression isn't responding to other treatments?
2Since this study uses tDCS, which is a form of brain stimulation delivered through electrodes on the scalp, can you explain what the actual experience of receiving tDCS is like and whether there are any known risks I should understand before considering it?
3This trial is listed as Phase NA, which sometimes means it's a device or behavioral study rather than a drug trial — how does that affect what's already known about the safety and effectiveness of tDCS for depression, and what gaps in evidence might still exist?
4Before I look further into this study, would you recommend I try any established depression treatments first, or do you think exploring something targeting sleep could make sense at this point in my care?
5The trial is actively recruiting right now — if I were interested in discussing it further, what would the time commitment and visit schedule likely look like, and is that realistic given everything else I'm managing?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. Clinically significant suicidal ideation or behavior, based on clinician assessment and the Columbia-Suicide Severity Rating Scale (C-SSRS).
. 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.
. History of seizure disorder or epilepsy.
. 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.
. Current use of prescription or over-the-counter sleep medications, or active participation in any behavioral or pharmacologic treatment specifically targeting sleep.
. 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.