NCT06142955

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

Neuromodulation for Depression in Autism Spectrum Disorder

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Yale University · Academic / Other
• Sex: All
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

Summary

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).

Detailed description

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.

Conditions

• Autism Spectrum Disorder

Interventions

Type	Name	Description
DEVICE	MAGSTIM Rapid2 TMS system	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.

Timeline

• Start date: 2024-04-30
• Primary completion: 2026-12-01
• Completion: 2026-12-01
• First posted: 2023-11-22
• Last updated: 2025-07-02

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study