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| ID | Type | Description | Link |
|---|---|---|---|
| UM1TR004921 | U.S. NIH Grant/Contract | View source | |
| K99MH141192 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Center for Advancing Translational Sciences (NCATS) | NIH |
| National Institute of Mental Health (NIMH) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TMS | Device | Transcranial magnetic stimulation (TMS) applies magnetic pulses to stimulate nerve cells in the brain. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hansong Lee, MS | Contact | 408-909-2203 | kellerlab@stanford.edu |
| Name | Affiliation | Role |
|---|---|---|
| Umair Hassan, PhD | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University | Recruiting | Stanford | California | 94305 | United States |
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| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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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) |
| 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. | 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. | 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. | Baseline, end of sleep stage (3 hours) |