Anxiety & Depression Association of America

Sleep TMS for Depression

Purpose

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

Eligibility

Eligible Ages: Between 18 Years and 65 Years
Eligible Sex: All
Accepts Healthy Volunteers: Yes

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

Phase: N/A
Study Type: Interventional
Allocation: Randomized
Intervention Model: Crossover Assignment
Primary Purpose: Basic Science
Masking: Double (Participant, Investigator)

Arm Groups

Arm	Description	Assigned Intervention
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.	Device: TMS Transcranial magnetic stimulation (TMS) applies magnetic pulses to stimulate nerve cells in the brain.
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.	Device: TMS Transcranial magnetic stimulation (TMS) applies magnetic pulses to stimulate nerve cells in the brain.

Recruiting Locations

More Details

Status: Recruiting
Sponsor: Stanford University

Study Contact

Hansong Lee, MS
408-909-2203
kellerlab@stanford.edu

Detailed Description

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

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.