NCT06824415 · Stanford University
Sleep TMS for Depression
What this study is about
The goal of this study is to establish the feasibility, tolerability, and preliminary effectiveness of sleep-state transcranial magnetic stimulation (TMS) for enhancing plasticity in depression treatment.
View original scientific description
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.
Interventions
DEVICE
TMS
Transcranial magnetic stimulation (TMS) applies magnetic pulses to stimulate nerve cells in the brain.
Primary outcome measures
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. 1\) tbs; 2) sleep (cortical excitability and plasticity measures) in both active and sham.
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.
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.
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.
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.
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Stanford, California
Collaborators
National Center for Advancing Translational Sciences (NCATS), National Institute of Mental Health (NIMH)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 23, 2026 · Source of record for eligibility and locations