Neuromodulation for Depression in Autism Spectrum Disorder

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 40
Healthy Volunteers: t
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• Individuals from Yale University and the surrounding community who are between the ages of 18 and 40 years old with or without a diagnosis of depression. Or individuals between the ages of 18 and 40 years old with a diagnosis of autism spectrum disorder, autistic disorder, PDD NOS, or Asperger syndrome with or without a diagnosis of depression.

• A depression score on the HDRS-17 of at least 20 will be used as a cut-off for depression.

• Participants are unmedicated or on stable medication treatment for at least two weeks.

• Willingness and ability to participate in an EEG and eye-tracking procedure.

• Provision of signed and dated informed consent.

Locations
United States
Connecticut
Yale Psychiatric Hospital
RECRUITING
New Haven
Contact Information
Primary
Sherab Tsheringla, MD
sherab.tsheringla@yale.edu
2032158046
Time Frame
Start Date: 2024-04-30
Estimated Completion Date: 2026-12
Participants
Target number of participants: 60
Treatments
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.
Related Therapeutic Areas
Autism Spectrum Disorder
Sponsors
Leads: Yale University
Collaborators: American Academy of Child Adolescent Psychiatry.

This content was sourced from clinicaltrials.gov

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