Yale Psychiatric Hospital
New Haven, Connecticut, 06520, United States
Location status: Recruiting
NCT Number: NCT06142955
This study will assess clinical and behavioral measures along with electroencephalogram (EEG), event-related potentials (ERPS), and eye-tracking (ET) prior to and following a single intermittent Theta Burst Stimulation (iTBS) session to provide preliminary insight into the potential of TMS as an intervention for depression in individuals with Autism Spectrum Disorder (ASD).
Interested in participating?
Request Info18 year–40 year
All sexes
Interventional
Not applicable
New Haven, Connecticut, 06520, United States
Location status: Recruiting
Participants will complete two separate sessions, approximately one week apart, with each session including: 1) a baseline assessment of neuropsychological, cognitive and behavioral function, 2) neural and visual attentional social response (EEG/ET paradigm), 3) a single iTBS session or sham stimulation to the left DLPFC, and 4) poststimulation assessment of neural and visual attentional social response (EEG/ET paradigm). The order of active stimulation versus sham will be randomized such that half of the participants in each group get the sham stimulation during the first session and half will get active stimulation in the first session then crossover. EEG and eye-tracking will take approximately 60-minutes and will be collected pre-and-post TMS administration.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The device will administer TMS pulses in bursts at fixed intervals for a total of 600 pulses over 190 seconds after first assessing the participants motor threshold (MT). During the sham stimulation condition, the TMS coil will be tilted 90° tangential to the scalp during the administration so that the orientation is not biologically active and will not elicit a muscle contraction. This sham condition will look and sound just like real TMS.
Time frame: baseline and up to week 2
As measured by amplitude and latency of event related potentials (ERP) (the right lateralized P100, P200 and amplitude of N170) to sad faces. EEG: an electrophysiological assay that measures brain activity from the scalp.
Time frame: baseline and up to week 2
ET will measure participant attention to the screen and be used to ensure that participants are looking at the stimulus display screen during the course of the experimental paradigms. Change in Proportion of fixation (POF) to the eye region in sad faces as measured by ET.
Time frame: baseline and up to week 2
ASSR measures an electrophysiological response in the human cortex after presenting stimulation consisting of pure tones at certain frequencies. For assessment of ASSRs, subjects will sit in an acoustically shielded booth in front of a computer monitor with eyes open, while passively listening to click trains presented through Etymotic insert ER-1 earphones (Etymotic Research, Elk Grove Village, IL). Stimuli will consist of standard, unattended (nontarget) auditory click trains from a three-stimulus oddball tasks. The output is thus measured in the EEG recording which is analyzed in the frequency domain. Measures of inter-trial coherence (ITC) are used to determine neural synchrony through the ASSR task, by quantifying the degree of phase consistency across trials. ASSR Power is the magnitude of the brain's voltage response to a stimulus and the consistency across trials of the time course of this time-locked response.
Time frame: baseline and up to week 2
The latency of the right lateralized N170, an ERP component that reflects the neural processing of faces, familiar objects, or words, to sad faces.
Time frame: baseline and up to week 2
The amplitude and latency of the right lateralized N170 as measured from eye-fixation related potentials (EFRP) when participants are viewing different emotionally valenced faces.
Time frame: baseline and up to week 2
ET will measure participant attention to the screen and be used to ensure that participants are looking at the stimulus display screen during the course of the experimental paradigms. Change in proportion of fixation to eyes in neutral faces and non-social stimuli (i.e., houses).
Time frame: baseline and up to week 2
The latency to look to the eye-region of faces relative to image onset, measured in milliseconds (ms) for sad and neutral faces and triangle pursuit duration in an anthropomorphic animated triangles test.
Contact information is provided by the study sponsor or research team.
Yale University
Other
Neuromodulation for Depression in Autism Spectrum Disorder
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