Transcranial Magnetic Stimulation (TMS) to Treat Depression in Autism Spectrum Disorder

Part of paid clinical trials in New Haven, Connecticut.

Sponsor
Yale University
Study ID
NCT06142955
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 40 Years
Healthy Volunteers
Accepted

Interventions

  • MAGSTIM Rapid2 TMS system — DEVICE
    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.

Study Details

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).

Key Dates

Start date
Apr 30, 2024
Status verified
Jun 2025
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION

Arms

  • Experimental: ASD with depression, iTBS then Sham
    Participants having ASD with depression will undergo EEG and ET with TMS prior to and following a single iTBS session. Participants first received iTBS then sham approximately one week apart.
  • Experimental: ASD with depression, Sham then iTBS
    Participants having ASD with depression will undergo EEG and ET with TMS prior to and following a single iTBS session.Participants first received sham then iTBS approximately one week apart.
  • Experimental: ASD without depression, iTBS then Sham
    Participants having ASD without depression will undergo EEG and ET with TMS prior to and following a single iTBS session. Participants first received iTBS then sham approximately one week apart.
  • Experimental: ASD without depression, Sham then iTBS
    Participants having ASD without depression will undergo EEG and ET with TMS prior to and following a single iTBS session.Participants first received sham then iTBS approximately one week apart.
  • Experimental: TD with depression, iTBS then Sham
    Participants that are TD with depression will undergo EEG and ET with TMS prior to and following a single iTBS session. Participants first received iTBS then sham approximately one week apart.
  • Experimental: TD with depression, Sham then iTBS
    Participants that are TD with depression will undergo EEG and ET with TMS prior to and following a single iTBS session. Participants first received sham then iTBS approximately one week apart.
  • Experimental: TD without depression, iTBS then Sham
    Participants that are TD without depression will undergo EEG and ET with TMS prior to and following a single iTBS session. Participants first received iTBS then sham approximately one week apart.
  • Experimental: TD without depression, Sham then iTBS
    Participants that are TD without depression will undergo EEG and ET with TMS prior to and following a single iTBS session. Participants first received sham then iTBS approximately one week apart.

Primary Outcome Measure

Change in Electroencephalogram (EEG) brain responses to sad faces [ Time Frame: baseline and up to week 2 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Yale Psychiatric HospitalNew HavenConnecticut06520-

Find similar trials in New Haven, CT

By condition
Autism spectrum disorder
By specialty
Pediatrics
By research site
Yale Psychiatric Hospital· New Haven, CT

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