Sleep TMS for Depression

Stanford University55 enrolled

Overview

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.

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

DOUBLE

Enrollment

Conditions

Major Depression Sleep

Interventions

TMSDEVICE

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Stanford University

Stanford, California, United States

RECRUITING

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Central Contacts

Hansong Lee, MS

CONTACT

408-909-2203 kellerlab@stanford.edu

Data from ClinicalTrials.gov

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Secondary Outcomes

Changes in Pittsburgh Sleep Quality Index (PSQI) Scores

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).

Time frame: After each sleep session (3 hours)

Changes in Treatment Tolerability

Treatment tolerability will be assessed through subject-reported comfort ratings on loudness, scalp sensation, and pain perception on scales ranging from 0 to 10.

Time frame: After each sleep session (3 hours)

Change in EEG Spectral Power and Phase Measures

Changes in EEG spectral power and phase-related measures across predefined frequency bands following iTBS to assess neural oscillatory activity.

Time frame: Baseline, end of sleep stage (3 hours)

Change in Functional Connectivity Measures

Changes in phase-based relationships between EEG sensors to assess connectivity changes following iTBS.

Time frame: Baseline, end of sleep stage (3 hours)