RecruitingNot applicable

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

Neuromodulation for Depression in Autism Spectrum Disorder

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 40 Years
Sex
All sexes
Healthy volunteers
Accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study looks at whether TMS, a treatment that uses magnetic pulses to stimulate the brain, may help depression in people with autism. Adults ages 18 to 40, with or without autism or depression, may take part. Researchers will check symptoms, behavior, brain activity, and eye movements before and after one treatment session.

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).

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be ages 18 to 40 and from Yale University or the nearby community, or have an autism diagnosis, including Asperger syndrome or PDD NOS.
  • You may have depression or not. A score of 20 or higher on the HDRS-17 depression scale counts as depression for this study.
  • Take no medicine, or have been on a stable medicine treatment for at least 2 weeks.
  • Be willing and able to have an EEG, which records brain activity, and a test that tracks eye movements.
  • Be able to agree to join the study and sign and date a consent form.

Who can't join

  • A major head injury, serious brain illness, serious medical illness, stroke, seizures, seizure-like EEG results, or a family history of epilepsy.
  • A mental illness that prevents you from finishing study tests, a psychotic illness, or bipolar disorder.
  • Medicine that may affect the thinking skills being studied or raise seizure risk.
  • Alcohol or recreational drug use within 24 hours before the visit, checked by a urine test; or alcohol or drug abuse or dependence in the past 6 months.
  • High suicide risk, current thoughts of suicide, or a suicide attempt in the past 6 months.
  • Known or suspected pregnancy, or a positive pregnancy test.
  • Past metalworking or injury from shrapnel or metal objects; past TMS treatment; or use of an experimental drug within 12 weeks before the visit.
  • An IQ score below 80 on the study's intelligence test, or inability to sign a consent form.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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)

Study sites (1)

CT