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

Official title

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

Overview

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.

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.

Interventions

• 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.

Primary outcome measures

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

Secondary outcome measures (7)

• Change in wake after sleep onset (WASO) [Time frame: Baseline, Post-Intervention (Week 5)]
• Change in night-to-night variability in sleep efficiency [Time frame: Baseline, Post-Intervention (Week 5)]
• Change in total sleep time [Time frame: Baseline, Post-Intervention (Week 5)]
• Change in sleep latency [Time frame: Baseline, Post-Intervention (Week 5)]
• Change in Montgomery-Åsberg Depression Rating Scale (MADRS-S) score [Time frame: Baseline, Final Follow-Up Study Visit (Month 2)]
• Change in Patient Health Questionnaire-8 (PHQ-8) score [Time frame: Baseline, Final Follow-Up Study Visit (Month 2)]
• Change in Quick Inventory of Depressive Symptomatology-Self-Report (QIDS-SR) score [Time frame: Baseline, Final Follow-Up Study Visit (Month 2)]

Eligibility criteria

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.
• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

United States · 1 center

• NYU Langone Health — New York

Identifiers

NCT: NCT07572526 · 26-00329

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗