Sleep TMS for Depression
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorStanford University
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Adults ages 18-65 years
Current Major Depressive Disorder (MDD) diagnosis
Failed ≥1 antidepressant medication
Moderate-to-severe depression
Disqualifiers
Intellectual disability
Significant head injury/neurological disorder
Pregnancy or postpartum
TMS/MRI contraindications
Trial design
Design model
Crossover
Treatments tested in this trial
TMS
DeviceTranscranial magnetic stimulation (TMS) applies magnetic pulses to stimulate nerve cells in the brain.
Treatment groups
55 Participants
are divided into 2 treatment groupsGroup A: Active TMS, Sham TMSExperimental treatment 1 intervention
Group B: Sham TMS, Active TMSExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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)2
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)3
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)4
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)Secondary outcomes
1
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)2
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)3
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)4
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)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Stanford University
Lead sponsor
National Center for Advancing Translational Sciences (NCATS)
Collaborator
National Institute of Mental Health (NIMH)
Collaborator
Source ClinicalTrials.gov