Sleep TMS for Depression

Not Applicable

Not yet recruiting

• Conditions: Major Depression; Sleep

• Registration Number: NCT06824415
• Lead Sponsor: Stanford University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-02-07
• Study First Submitted QC: 2025-02-07
• Study First Posted: 2025-02-13
• Status Verified: 2025-05
• Study Start: 2025-05
• Primary Completion: 2025-05
• Last Update Submitted: 2025-05-01
• Last Update Posted: 2025-05-06
• Study Completion: 2025-06

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

• Current Major Depressive Disorder (MDD) diagnosis
• Failed >= 1 antidepressant medication
• Moderate-to-severe depression

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Change in Baseline TMS-EEG after iTBS	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 N-back Reaction Time Performance	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 Reaction Time Performance	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.
Change in N-back Accuracy Performance	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 MSIT Accuracy Performance	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 Baseline TMS-EEG after NREM Sleep	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.

Secondary Outcome Measures

Name	Time	Method
Changes in Pittsburgh Sleep Quality Index (PSQI) Scores	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).
Changes in Treatment Tolerability	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.

Trial Locations

Locations (1)

Stanford University; 🇺🇸 Stanford, California, United States