Major Depression, Sleep
Conditions
Keywords
sleep, tms, eeg, iTBS, real-time, closed-loop, NREM, sleep spindle, slow oscillations
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
Healthy control participant cohort funded through K99MH141192 and depressed patient cohort funded through K99MH141192 and UM1TR004921.
Interventions
DEVICETMS
Transcranial magnetic stimulation (TMS) applies magnetic pulses to stimulate nerve cells in the brain.
Sponsors
Stanford University
National Center for Advancing Translational Sciences (NCATS)
National Institute of Mental Health (NIMH)
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 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. |
| 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 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 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 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| Change in EEG Spectral Power and Phase Measures | Baseline, end of sleep stage (3 hours) | Changes in EEG spectral power and phase-related measures across predefined frequency bands following iTBS to assess neural oscillatory activity. |
| Change in Functional Connectivity Measures | Baseline, end of sleep stage (3 hours) | Changes in phase-based relationships between EEG sensors to assess connectivity changes following iTBS. |
Countries
United States
Contacts
CONTACTHansong Lee, MS
PRINCIPAL_INVESTIGATORUmair Hassan, PhD
Stanford University
Outcome results
None listed