tDCS: Sleep to Mood in Depression (S2M-D)
Sleep Consolidation as a Mechanistic Pathway Linking Home-Based tDCS to Antidepressant Response (S2M-D)
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years to 65 Years
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Procedures mentioned: Wearing a device
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "Sleep will be continuously monitored using a wearable device called an Oura Ring that captures sleep measures such as sleep duration, efficiency, awakenings, and night-to-night consistency."
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests whether sleep becomes less broken up during at-home tDCS, a treatment that uses a weak electrical current to stimulate the brain. It also looks at whether sleep changes happen along with improvements in depression symptoms. The study is for adults with moderate depression.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Can read and understand study materials in English, with a score above 85 on the WRAT-5 reading test.
- Score 18 or higher on the MADRS-S depression symptom survey at screening.
- Have major depressive disorder, confirmed through an interview with a clinician.
- If taking depression medicine, have taken the same dose for at least 30 days before pre-screening.
- Have a local care provider who can be contacted if depression raises safety concerns, or identify and acknowledge local help resources.
- Can give informed consent, meaning you understand and agree to join, and follow study steps.
- Have a quiet space for at-home tDCS sessions.
Who can't join
- Have a major health problem that the study clinician thinks could affect safety, participation, or study results.
- Have current or past bipolar disorder or a psychotic disorder, which can affect what seems real; or have had an alcohol or drug use disorder in the past 6 months.
- Have serious thoughts of suicide or suicidal behavior, based on a clinician's review and a suicide risk survey.
- Have used prescription or store-bought sleep medicines, or started behavior-based sleep treatment, in the 30 days before pre-screening.
- Have a history of seizures or epilepsy.
- Have an active implanted medical device above the neck, such as a brain stimulator or cochlear hearing implant, or metal implants in the head or neck that are not MRI-safe.
- Currently use sleep medicines or take part in any medicine-based or behavior-based treatment aimed at sleep.
- Are pregnant, planning pregnancy during the study, or breastfeeding. If able to become pregnant, you must use an accepted birth control method or avoid sex that could cause pregnancy.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
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.
Study sites (1)
NY
- NYU Langone Health · New York, NY 10016More trials in New York