Sleep TMS for Depression

NCT06824415 | Recruiting FDA Device

• 3 other identifiers: 60980-3UM1TR004921K99MH141192
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (6)

• Change in Baseline TMS-EEG after iTBS

  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.

  Baseline, end of iTBS (3 minutes)

• Change in Baseline TMS-EEG after NREM Sleep

  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.

  Baseline, end of sleep stage (3 hours)

• Change in N-back Accuracy Performance

  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.

  Baseline, end of sleep stage (3 hours)

• Change in N-back Reaction Time Performance

  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.

  Baseline, end of sleep stage (3 hours)

• Change in MSIT Accuracy Performance

  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.

  Baseline, end of sleep stage (3 hours)

• Change in MSIT Reaction Time Performance

  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.

  Baseline, end of sleep stage (3 hours)

Secondary Outcomes (4)

• Changes in Pittsburgh Sleep Quality Index (PSQI) Scores

  After each sleep session (3 hours)

• Changes in Treatment Tolerability

  After each sleep session (3 hours)

• Change in EEG Spectral Power and Phase Measures

  Baseline, end of sleep stage (3 hours)

• Change in Functional Connectivity Measures

  Baseline, end of sleep stage (3 hours)

Study Arms (2)

Active TMS, Sham TMS

EXPERIMENTAL

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.

Device: TMS

Sham TMS, Active TMS

EXPERIMENTAL

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.

Device: TMS

Interventions

TMS DEVICE

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

Active TMS, Sham TMS; Sham TMS, Active TMS

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Stanford University: lead
• National Center for Advancing Translational Sciences (NCATS): collaborator
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Stanford University

Stanford, California, 94305, United States

RECRUITING

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Study Officials

• Umair Hassan, PhD

  Stanford University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hansong Lee, MS

CONTACT

408-909-2203; kellerlab@stanford.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Postdoctoral Researcher in Department of Psychiatry and Behavioral Sciences

Study Record Dates

• First Submitted: February 7, 2025
• First Posted: February 13, 2025
• Study Start: May 1, 2025
• Primary Completion (Estimated): May 30, 2028
• Study Completion (Estimated): May 30, 2028
• Last Updated: June 23, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)