tDCS: Sleep to Mood in Depression (S2M-D)

NCT07572526 | Not Yet Recruiting FDA Device

• 1 other identifier: 26-00329
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Change in sleep efficiency

  Sleep efficiency (SE) is the percentage of time spent asleep while in bed. A healthy, normal efficiency is 85% or higher, with 90% or more considered very good. Low efficiency can indicate poor sleep quality.

  Baseline, Post-Intervention (Week 5)

Secondary Outcomes (7)

• Change in wake after sleep onset (WASO)

  Baseline, Post-Intervention (Week 5)

• Change in night-to-night variability in sleep efficiency

  Baseline, Post-Intervention (Week 5)

• Change in total sleep time

  Baseline, Post-Intervention (Week 5)

• Change in sleep latency

  Baseline, Post-Intervention (Week 5)

• Change in Montgomery-Åsberg Depression Rating Scale (MADRS-S) score

  Baseline, Final Follow-Up Study Visit (Month 2)

Study Arms (1)

Active transcranial direct current stimulation (tDCS)

EXPERIMENTAL

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).

Device: transcranial direct current stimulation (tDCS)

Interventions

transcranial direct current stimulation (tDCS) DEVICE

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.

Active transcranial direct current stimulation (tDCS)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• NYU Langone Health: lead
• Zabara Foundation: collaborator

Study Sites (1)

NYU Langone Health

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Depressive Disorder, Major; Depression

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Officials

• Giuseppina Pilloni

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shayna Pehel

CONTACT

929-455-5104; Shayna.Pehel@nyulangone.org

Giuseppina Pilloni

CONTACT

929-455-5317; Giuseppina.Pilloni@nyulangone.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 1, 2026
• First Posted: May 7, 2026
• Study Start (Estimated): May 27, 2026
• Primary Completion (Estimated): November 30, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: May 7, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)