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RECRUITINGINTERVENTIONAL

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

Neuromodulation for Depression in Autism Spectrum Disorder

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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).

Who May Be Eligible (Plain English)

Who May Qualify: - 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 willing to sign a consent form. Who Should NOT Join This Trial: - Participants reporting significant head trauma or serious brain illness. - Participants unable to provide signed willing to sign a consent form. - 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. ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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)

Treatments Being Tested

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.

Locations (1)

Yale Psychiatric Hospital
New Haven, Connecticut, United States