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Transcranial Magnetic Stimulation (TMS) to Treat Depression in Autism Spectrum Disorder
RECRUITINGN/ASponsored by Yale University
Actively Recruiting
PhaseN/A
SponsorYale University
Started2024-04-30
Est. completion2026-12
Eligibility
Age18 Years – 40 Years
Healthy vol.Accepted
Locations1 site
View on ClinicalTrials.gov →
NCT06142955
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
Age: 18 Years – 40 YearsHealthy volunteers accepted
Inclusion Criteria: * 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 Criteria: * 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)
Conditions2
Autism Spectrum DisorderDepression
Locations1 site
Yale Psychiatric Hospital
New Haven, Connecticut, 06520
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Actively Recruiting
PhaseN/A
SponsorYale University
Started2024-04-30
Est. completion2026-12
Eligibility
Age18 Years – 40 Years
Healthy vol.Accepted
Locations1 site
View on ClinicalTrials.gov →
NCT06142955