Autism Spectrum Disorder Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

Pilot Phase (ages 18–25, healthy volunteers):

• People aged 18 to 25 years old
• People who are able to give their own informed consent to participate
• People who have already completed a screening assessment under one of two specific NIMH research protocols (01-M-0254 or 17-M-0181) and meet the definition of a "Healthy Control" under those protocols (confirm with trial site)

Main Study Phase (ages 11–17, autism diagnosis):

• Children and teenagers aged 11 to 17 years old
• Young people whose parent or guardian is able to give consent on their behalf, and who are themselves able to give their agreement to take part (consent forms are available in English or Spanish for parents)
• Young people who have a community diagnosis of autism spectrum disorder (ASD) based on recognised diagnostic standards (DSM-IV or DSM-5), which will be reviewed by the study team
• Young people who score above 70 on a standard intelligence assessment called the WASI-II
• People who are right-handed
• People with normal hearing

Who may not be able to join:

Pilot Phase:

• People who do not speak English
• People with a known neurological condition
• People with a known psychiatric condition
• People with a known genetic disorder (such as neurofibromatosis or tuberous sclerosis), an acquired brain condition (such as stroke or brain tumour), cerebral palsy, or significant physical differences affecting the brain or skull
• People who have had unexplained fainting spells that may have been seizures
• People with a personal history of seizures or epilepsy, or who have a first-degree family member (such as a parent or sibling) with epilepsy
• People with chronic or uncontrolled medical conditions that could become dangerous if a seizure were triggered (such as certain heart or breathing conditions)
• People with a past or current history of tinnitus (ringing in the ears)
• People with any implant, prosthetic device, or permanent body alteration that the investigator considers unsafe for MRI or brain stimulation (TMS), or that could affect the quality of the data
• People showing signs of increased pressure inside the skull
• People with any lesion or abnormality inside the skull — including something found unexpectedly on an MRI scan — that the investigator considers unsafe or that could affect data quality
• People who have had a head injury within the past 6 months, or a past head injury that showed abnormalities on a brain scan, involved loss of consciousness for more than 5 minutes, or caused lasting effects beyond headache for more than 24 hours
• People who are pregnant
• People who have received repetitive TMS (rTMS) brain stimulation within the 7 days before enrolling
• People currently taking certain medications that lower the brain's seizure threshold, including GABAergic medications (confirm with trial site)
• People for whom it would not be safe or appropriate to remain on a stable medication routine for at least six weeks before and throughout the study
• Current employees or staff of the NIMH, or their immediate family members

Main Study Phase:

• People who do not speak English
• Young people with a known genetic disorder that is linked to their ASD diagnosis, or that the investigator believes could increase risks or affect data quality
• Young people with an acquired brain condition (such as stroke or brain tumour), cerebral palsy, or significant physical differences affecting the brain or skull
• Young people who have had unexplained fainting spells that may have been seizures
• Young people with a personal history of seizures or epilepsy, or who have a first-degree family member (such as a parent or sibling) with epilepsy
• Young people with a progressive neurological disorder (such as a neurodegenerative condition)
• Young people with chronic or uncontrolled medical conditions that could become dangerous if a seizure were triggered (such as certain heart or breathing conditions)
• Young people with a past or current history of clinically significant tinnitus (ringing in the ears), as assessed by an audiologist or licensed clinician
• Young people with any implant, prosthetic device, or permanent body alteration that the investigator considers unsafe for MRI or TMS, or that could affect data quality
• Young people showing signs of increased pressure inside the skull
• Young people with any lesion or abnormality inside the skull — including something found unexpectedly on an MRI scan — that the investigator considers unsafe or that could affect data quality
• Young people who have had a head injury within the past 6 months, or a past head injury that showed abnormalities on a brain scan, involved loss of consciousness for more than 5 minutes, or caused lasting effects beyond headache for more than 24 hours
• Young people who are pregnant
• Young people who have ever previously received rTMS brain stimulation
• Young people with a current or past history of psychosis, bipolar disorder, active severe substance use (within the past month), or who have active suicidal thoughts or a plan, or who the investigator believes may be at risk of a suicide attempt within 6 months
• Young people currently taking certain medications that lower the brain's seizure threshold, including GABAergic medications, or who have recently had a medication change with that effect (confirm with trial site)
• Young people with any other medical, neurological, or genetic condition, injury, or disorder that the investigator believes could meaningfully increase the risks of taking part, affect the person's ability to complete the study, or compromise data quality

Important: Always verify eligibility with the trial site directly before applying.