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NCT Number: NCT06824415

Sleep TMS for Depression

The goal of this study is to establish the feasibility, tolerability, and preliminary efficacy of sleep-state transcranial magnetic stimulation (TMS) for enhancing plasticity in depression treatment.

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Key information

Conditions

Major Depression Depressive Disorder Depressive Disorder, Major Mental Disorders Mood Disorders Sleep

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stanford University

Stanford, California, 94305, United States

Location status: Recruiting

Location contact

Hansong Lee, MS

CONTACT

[email protected]

408-909-2203

About this study

Healthy control participant cohort funded through K99MH141192 and depressed patient cohort funded through K99MH141192 and UM1TR004921.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adults ages 18-65 years
  • Current Major Depressive Disorder (MDD) diagnosis
  • Failed ≥1 antidepressant medication
  • Moderate-to-severe depression
  • Stable antidepressant medication dose for ≥ 6 weeks prior to enrollment
  • Healthy control participants are adults ages 18-65 years without current MDD symptoms, not taking antidepressant or antipsychotic medications, and without major psychiatric, neurological, substance use, medical conditions affecting brain function, or TMS/MRI contraindications.

Exclusion criteria

  • Intellectual disability
  • Significant head injury/neurological disorder
  • Pregnancy or postpartum
  • TMS/MRI contraindications
  • Active substance use/suicidal ideation

Treatment and study plan

TMS

Device

Transcranial magnetic stimulation (TMS) applies magnetic pulses to stimulate nerve cells in the brain.

Primary outcomes

  1. Change in Baseline TMS-EEG after iTBS

    Time frame: Baseline, end of iTBS (3 minutes)

    Changes in Early Local TMS-Evoked Potentials (EL-TEP) following 3 minutes of either active or sham iTBS in each session to assess cortical excitability and plasticity measures.

    • tbs; 2) sleep (cortical excitability and plasticity measures) in both active and sham.

  2. Change in Baseline TMS-EEG after NREM Sleep

    Time frame: Baseline, end of sleep stage (3 hours)

    Changes in Early Local TMS-Evoked Potentials (EL-TEP) following 3 hours of NREM sleep in each session to assess cortical excitability and plasticity measures.

  3. Change in N-back Accuracy Performance

    Time frame: Baseline, end of sleep stage (3 hours)

    N-back task (15-min) measures working memory performance and accuracy will be determined by the number of correct responses to the stimulus. Change in accuracy performance will be assessed before and after NREM sleep.

  4. Change in N-back Reaction Time Performance

    Time frame: Baseline, end of sleep stage (3 hours)

    N-back task (15-min) measures working memory performance and reaction time will be determined by the time it takes for the participant to respond to the stimulus. Change in reaction time performance will be assessed before and after NREM sleep.

  5. Change in MSIT Accuracy Performance

    Time frame: Baseline, end of sleep stage (3 hours)

    Multi-source Interference Task (MSIT; 15-min) measures cognitive control performance and accuracy will be determined by the number of correct responses to the stimulus. Change in accuracy performance will be assessed before and after NREM sleep.

  6. Change in MSIT Reaction Time Performance

    Time frame: Baseline, end of sleep stage (3 hours)

    Multi-source Interference Task (MSIT; 15-min) measures cognitive control performance and reaction time will be determined by the time it takes for the participant to respond to the stimulus. Change in reaction time performance will be assessed before and after NREM sleep.

Secondary outcomes

  1. Changes in Pittsburgh Sleep Quality Index (PSQI) Scores

    Time frame: After each sleep session (3 hours)

    The Pittsburgh Sleep Quality Index (PSQI) contains 19 self-rated questions which measures seven aspects of sleep: (1) subjective sleep quality, (2) sleep latency, (3) sleep duration, (4) habitual sleep efficiency, (5) sleep disturbances, (6) use of sleeping medication, and (7) daytime dysfunction. The 19 self-rated items are combined to form seven component scores, each of which has a range of 0-3 points (0 indicates no difficulty, while 3 indicates severe difficulty). The seven component scores are then summed to yield one global score, with a range of 0-21 points (0 indicating no difficulty, and 21 indicating severe difficulties in all the seven areas of sleep quality).

  2. Changes in Treatment Tolerability

    Time frame: After each sleep session (3 hours)

    Treatment tolerability will be assessed through subject-reported comfort ratings on loudness, scalp sensation, and pain perception on scales ranging from 0 to 10.

  3. Change in EEG Spectral Power and Phase Measures

    Time frame: Baseline, end of sleep stage (3 hours)

    Changes in EEG spectral power and phase-related measures across predefined frequency bands following iTBS to assess neural oscillatory activity.

  4. Change in Functional Connectivity Measures

    Time frame: Baseline, end of sleep stage (3 hours)

    Changes in phase-based relationships between EEG sensors to assess connectivity changes following iTBS.

Study contacts

Contact information is provided by the study sponsor or research team.

Hansong Lee, MS

CONTACT

[email protected]

408-909-2203

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Collaborators

  • National Center for Advancing Translational Sciences (NCATS)
  • National Institute of Mental Health (NIMH)

Registry information

Official study title

Optimizing Depression Treatment Through Sleep-state Brain Stimulation

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Feb 13, 2025
Registry last updated
Jun 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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