Status:
RECRUITING
Transcranial Magnetic Stimulation (TMS) to Treat Depression in Autism Spectrum Disorder
Lead Sponsor:
Yale University
Collaborating Sponsors:
American Academy of Child Adolescent Psychiatry.
Conditions:
Autism Spectrum Disorder
Eligibility:
All Genders
18-40 years
Phase:
NA
Brief 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...
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) neura...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- Participants reporting significant head trauma or serious brain illness.
- Participants unable to provide signed informed consent.
- Participants with major psychiatric illness that would preclude completion of study measures. Participants with diagnosis of a psychotic or bipolar illness with be excluded.
- Participants with a history of serious medical illness, stroke, seizures, epileptiform EEG abnormalities, or family history of epilepsy.
- Participants taking prescription medications that may affect cognitive processes under study.
- Participants taking any medication that may increase their risk of seizures.
- Participants who have taken alcohol or recreational drugs within the preceding 24 hours prior to the scheduled study visit as determined by the urine toxicology test.
- Participants with a history of substance or alcohol abuse or dependence in the past 6 months.
- Participants with a significant risk of suicide or a h/o suicide attempt in the last 6 months. Participants with active suicidal ideation will be excluded from the study.
- Females of known/suspected pregnancy or who test positive on a pregnancy test.
- Participants with a history of metalworking or injury by shrapnel or metallic objects.
- Participants with a history of prior TMS therapy or use of an investigational drug within 12 weeks of visit
- Participants with an IQ below 80 (as confirmed by the WASI, Wechsler Abbreviated Scale of Intelligence)
Key Trial Info
Start Date :
April 30 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06142955
Start Date
April 30 2024
End Date
December 1 2026
Last Update
July 2 2025
Active Locations (1)
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1
Yale Psychiatric Hospital
New Haven, Connecticut, United States, 06520