Recruiting

tDCS

Sponsor:

NYU Langone Health

Code:

NCT07572526

Conditions

Major Depressive Disorder

MDD

Depression

Major Depressive Episode

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

transcranial direct current stimulation (tDCS)

Study Details

Brief 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.

Conditions

Major Depressive Disorder

MDD

Depression

Major Depressive Episode

Study ID

NCT07572526

Start date

Jun 4, 2026

Status verified date

Jun, 2026

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Nov 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

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 Design

Enrollment

35 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Active transcranial direct current stimulation (tDCS)

Participants will complete a 20-session course of home-based left dorsolateral prefrontal cortex (DLPFC) transcranial direct current stimulation (tDCS) (2.0 mA, 30 minutes per session).

Interventions

transcranial direct current stimulation (tDCS)

Transcranial direct current stimulation delivers a gentle, low-intensity electrical current. The tDCS device is programmed to ramp up to 2.0 mA (for 30 seconds), deliver constant current throughout the session (29 minutes), and then ramp down (for 30 seconds) at the end of the session.

Primary outcome measure

  • Change in sleep efficiency [ Time Frame: Baseline, Post-Intervention (Week 5) ]

Central Contacts and Locations

Locations

NYU Langone Health

Recruiting

New York, New York, United States, 10016

More Information

Sponsor

NYU Langone Health

Last update posted

Jun 8, 2026

Last verified

Jun, 2026

Keywords

  • MDD
  • Brain stimulation
  • Depression
  • tDCS
  • Neuromodulation
  • Wearable
  • Telehealth

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by NYU Langone Health on 2026-06-08.