Effect of aiTBS on Intrinsic Spectral Dynamics and Task Performance
ConditionBrain Plasticity
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-50
SponsorUniversity of Pennsylvania
About this trial
Aim 1: Measure local shifts in cortical spectral dynamics following aiTBS. Aim 2: Measure network-specific shifts in task performance following aiTBS. Exploratory aim: Evaluate changes to resting state spectral dynamics in absence of stimulation after aiTBS.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Able to give their consent
Right-handed or ambidextrous
Disqualifiers
Non-english speaking
Current or past non-anxiety-related psychiatric comorbidity.
Active or history of active suicidal ideation
Alcohol/drug problems in the past year or lifetime alcohol or drug dependence
Trial design
Design model
Parallel
Treatments tested in this trial
TBS
DeviceaiTBS stimulation parameters. A MagVenture MagPro 100X stimulator with a B65 figure-8 coil will be used for the aiTBS sessions. A series of 20, 10 s trains will be presented over the course of the \~3.5 min session. Each train will consist of 2 s of stimulation with an 8 s ITI. During the 2 s of stimulation, 10, 50 Hz bursts will be repeated at intervals of 200 ms (5 Hz).
Treatment groups
80 Participants
are divided into 2 treatment groupsGroup A: dlPFC TMSExperimental treatment 1 intervention
Group B: TPJ TMSExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Spectral Dynamics
All participants will undergo TEP measurements before and after aiTBS therapy (peri-therapeutic) at the left DLPFC and left TPJ to evaluate changes cortical excitability. We will average the results of repeated single pulse stimulation at an intensity of 120% RMT. Participants will also undergo scalp EEG recording during aiTBS sessions and while at rest. Peri-therapeutic oscillatory bands will be determined by averaging responses to across multiple baseline recording sessions using the MATLAB toolbox FieldTrip for detection of signal within the 4-8Hz spectral band. We hypothesize that theta power increases in participants after completing three days of aiTBS when compared against their respective baselines. Intra-therapeutic changes to theta oscillatory signal will also be collected as an additional primary outcome. Averages of theta oscillatory power within each day of aiTBS will be recorded and compared against baseline.
Time frame
Participants will undergo six study visits spaced over a 2-week period. Outcome measures will be collected during study visits 2-6 during week 2.2
Task Performance
Participants will complete both a working memory and affective interference task. The primary outcome measure will be task performance as measured by response time for each subject. Values collected after aiTBS will be compared against their pre-stimulation counterparts using a paired t-test for a given task. The change in these metrics will then be compared across the two tasks using an unpaired t-test. Change in performance metrics for each task will similarly be compared against changes in metrics of the participant group receiving stimulation to the alternate site. We hypothesize performance on network-congruent tasks increase after aiTBS.
Time frame
Participants will undergo six study visits spaced over a 2-week period. Outcome measures will be collected during study visits 2-6 during week 2.Locations
Sponsors and contacts
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Source ClinicalTrials.gov
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