Recruiting

TMS

Sponsor:

Stanford University

Code:

NCT06824415

Conditions

Major Depression

Sleep

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

Interventions

TMS

Study Details

Brief summary:

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.

Conditions

Major Depression

Sleep

Study ID

NCT06824415

Start date

May 1, 2025

Status verified date

Jun, 2026

Completion date

May 30, 2028

Anticipated

Primary completion date

May 30, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

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

Study Design

Enrollment

55 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Active TMS, Sham TMS

Participants will receive 2 sessions of Transcranial Magnetic Stimulation (TMS) delivered using standard intermittent theta-burst (iTBS) parameters (600 pulses, 3 min, 120% rMT). Participants will receive, on separate sessions, either active or sham iTBS delivered during wakefulness and/or NREM sleep stages while recording with Electroencephalography (EEG). Participants will perform the N-back task and Multi-source Interference Task (MSIT) during each session to measure working memory and cognitive control performance.

experimental: Sham TMS, Active TMS

Participants will receive 2 sessions of Transcranial Magnetic Stimulation (TMS) delivered during using standard intermittent theta-burst (iTBS) parameters (600 pulses, 3 min, 120% rMT). Participants will receive, on separate sessions, either active or sham iTBS delivered during wakefulness and/or NREM sleep stages while recording with Electroencephalography (EEG). Participants will perform the N-back task and Multi-source Interference Task (MSIT) during each session to measure working memory and cognitive control performance.

Interventions

TMS

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

Primary outcome measure

  • Change in Baseline TMS-EEG after iTBS [ Time Frame: Baseline, end of iTBS (3 minutes) ]
  • Change in Baseline TMS-EEG after NREM Sleep [ Time Frame: Baseline, end of sleep stage (3 hours) ]
  • Change in N-back Accuracy Performance [ Time Frame: Baseline, end of sleep stage (3 hours) ]
  • Change in N-back Reaction Time Performance [ Time Frame: Baseline, end of sleep stage (3 hours) ]
  • Change in MSIT Accuracy Performance [ Time Frame: Baseline, end of sleep stage (3 hours) ]
  • Change in MSIT Reaction Time Performance [ Time Frame: Baseline, end of sleep stage (3 hours) ]

Central Contacts and Locations

Central contacts

Hansong Lee, MS

408-909-2203kellerlab@stanford.edu

Locations

Stanford University

Recruiting

Stanford, California, United States, 94305

Contacts

Hansong Lee, MS

408-909-2203kellerlab@stanford.edu

More Information

Sponsor

Stanford University

Last update posted

Jun 23, 2026

Last verified

Jun, 2026

Keywords

  • sleep
  • tms
  • eeg
  • iTBS
  • real-time
  • closed-loop
  • NREM
  • sleep spindle
  • slow oscillations

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Stanford University on 2026-06-23.