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

Sleep Consolidation as a Mechanistic Pathway Linking Home-Based tDCS to Antidepressant Response (S2M-D)

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.

Study Overview

• Status: Recruiting
• Conditions: Depression; Major Depressive Disorder; Major Depressive Episode; MDD
• Intervention / Treatment: Device: transcranial direct current stimulation (tDCS)

Detailed Description

This study evaluates the effects of home-based transcranial direct current stimulation (tDCS) on sleep and depressive symptoms in adults with moderate depression. tDCS is a noninvasive neuromodulation technique that delivers a mild electrical current to the scalp to modulate brain activity and has been studied as a potential treatment for depression.

Participants will self-administer tDCS for 20 sessions at home over the course of the study. 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. Depressive symptoms will be assessed longitudinally using validated clinical and self-report measures.

The primary objective is to determine whether changes in sleep consolidation occur over the course of tDCS treatment. A secondary objective is to evaluate whether changes in sleep are temporally associated with improvements in depressive symptoms.

This study aims to better characterize the relationship between sleep and depressive response during tDCS, and to identify potential sleep-related markers associated with clinical improvement in depression.

• Study Type: Interventional
• Enrollment (Estimated): 35
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Shayna Pehel; Phone Number: 929-455-5104; Email: Shayna.Pehel@nyulangone.org
• Study Contact Backup: Name: Giuseppina Pilloni; Phone Number: 929-455-5317; Email: Giuseppina.Pilloni@nyulangone.org

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • Recruiting
      • NYU Langone Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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).	Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in wake after sleep onset (WASO)	WASO represents the sum of all wakefulness durations after sleep initiation.	Baseline, Post-Intervention (Week 5)
Change in night-to-night variability in sleep efficiency	Night-to-night variability in sleep efficiency is measured as the percentage of time in bed actually spent sleeping. High variability can indicate poor sleep quality.	Baseline, Post-Intervention (Week 5)
Change in total sleep time		Baseline, Post-Intervention (Week 5)
Change in sleep latency	Sleep latency is the time it takes to transition from full wakefulness to sleep. An ideal sleep latency is typically 10-20 minutes.	Baseline, Post-Intervention (Week 5)
Change in Montgomery-Åsberg Depression Rating Scale (MADRS-S) score	MADRS-s is a 10-item self report questionnaire used to measure the severity of depressive episodes in patients with mood disorders. Each item is rated on a 0-6 scale, resulting in a total score range of 0-60. The higher the score, the more severe the depression.	Baseline, Final Follow-Up Study Visit (Month 2)
Change in Patient Health Questionnaire-8 (PHQ-8) score	The PHQ-8 consist of 8-items. Participants self-report the severity of current depression. Each item is scored 0-3 based on frequency (0: Not at all, 1: Several days, 2: More than half the days, 3: Nearly every day), with a total score ranging from 0 to 24. Higher scores indicate severe depression.	Baseline, Final Follow-Up Study Visit (Month 2)
Change in Quick Inventory of Depressive Symptomatology-Self-Report (QIDS-SR) score	The QIDS-SR is a 16-item self-report tool used to measure the severity of depressive symptoms. Scores range from 0-27, with higher scores indicating clinically significant depression.	Baseline, Final Follow-Up Study Visit (Month 2)

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Collaborators: Zabara Foundation
• Investigators: Principal Investigator: Giuseppina Pilloni, NYU Langone Health

Study record dates

Study Major Dates

• Study Start (Actual): June 4, 2026
• Primary Completion (Estimated): November 30, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: May 1, 2026
• First Submitted That Met QC Criteria: May 1, 2026
• First Posted (Actual): May 7, 2026

Study Record Updates

• Last Update Posted (Actual): June 8, 2026
• Last Update Submitted That Met QC Criteria: June 5, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Depression; tDCS; Neuromodulation; MDD; Telehealth; Brain stimulation; Wearable
• Additional Relevant MeSH Terms: Mental Disorders; Behavioral Symptoms; Mood Disorders; Depressive Disorder; Behavior; Depression; Depressive Disorder, Major; Therapeutics; Behavioral Disciplines and Activities; Electric Stimulation Therapy; Convulsive Therapy; Psychiatric Somatic Therapies; Electroshock; Psychological Techniques; Transcranial Direct Current Stimulation
• Other Study ID Numbers: 26-00329

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data (IPD) will not be shared due to the small sample size and risk of re-identification, as well as the exploratory nature of the study.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes