Sensory and Connectivity Abnormalities in Autism Spectrum Disorders

NCT ID: NCT00956579

Last Updated: 2020-09-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-06-30

Study Completion Date

2023-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Study the neural substrates of autism spectrum disorders using neuroimaging methods such as MEG/EEG/MRI.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

(NOTE: we are currently recruiting individuals between the ages of 14 and 32, either typically developing or with an autism spectrum disorder.)

To study how sensory information is processed by the brain, we primarily use an instrument called MEG (MagnetoEncephaloGraphy), which measures the magnetic brainwaves emitted by our brains. The device does not have any output (i.e., there is no magnetic field); it only measures the waves produced in the brain.

We measure those waves as the participants in the study listen to, view, or otherwise experience simple, non painful, stimuli. For instance, participants may listen to words while sitting in the MEG room, and watching a movie with the sound turned off.

We then combine this information with pictures of the brain from MRI (Magnetic Resonance Imaging - when available), to get an idea about both the anatomy and the function of the brain, so that we can study how the brains of populations with autism spectrum disorders or language disorders may be different from those of typically developing populations.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Autism Spectrum Disorder

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

OTHER

Study Time Perspective

OTHER

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Healthy individuals

No intervention

Healthy participants ages 14-32 for a neuroimaging study

No interventions assigned to this group

Individuals with Autism Spectrum Disorder

No intervention

ASD participants ages 14-32 for a neuroimaging study.

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* All of the following criteria must be met by all participants:

* The participant or the participant's legal guardian is able to understand and is willing to comply with the requirements of the study
* The participant meets the age requirements (14-32 years old)
* The participant or legal guardian has signed an Informed Consent Form specific to this study, and is able to understand the consent form.
* The participant must have English as their first language.
* The participant must have a non-verbal IQ \> 70
* For the ASD/language disorder group only:

* Autism Spectrum Disorder: Participants must meet criteria for Autism Spectrum Disorder on the ADOS.

Exclusion Criteria

* Any volunteer for whom informed consent cannot be obtained
* Volunteers with metal braces, extensive dental work involving metals, implanted electromagnetically activated medical equipment (cardiac pacemakers, neurostimulators, functioning infusion pumps), all of which would interfere with the MEG signal, will be excluded from the MEG portion of the study
* Volunteers with any medically diagnosed sensory loss
* Volunteers with a known genetic disorder (e.g. Tourette's syndrome, etc), or other medical condition affecting the brain, such as progressive encephalopathy as well as those who are on high doses of multiple anti-seizure medications and have frequent, uncontrolled seizures
* Asphyxia at birth or any other time, premature birth (Fewer than 34 weeks gestation)
* For the control group only:

* Volunteers diagnosed with a mental condition such as depression, anxiety, aggression, hyperactivity, attention deficit disorder (with or without hyperactivity).
* Volunteers who score below the autism spectrum cut-off (in the normal range) on the ADOS and SCQ
* Volunteers on any sort of neuro-psychopharmacological treatment (including antidepressants, stimulants, antipsychotics, anticonvulsants, benzodiazepines).
* For the autism group only:

* Children or adults not meeting criteria for autism spectrum disorder
* Volunteers with co-morbid disorders such as tuberous sclerosis or fragile X.
Minimum Eligible Age

14 Years

Maximum Eligible Age

32 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Institutes of Health (NIH)

NIH

Sponsor Role collaborator

National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

Massachusetts General Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Tal Kenet

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Tal Kenet, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Martinos Center or Biomedical Imaging

Charlestown, Massachusetts, United States

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United States

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Nicole McGuiggan, Rsch Coord

Role: CONTACT

617-966-9766

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

5R01MH117998

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2005P001768

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Studying Motor Neuron Tests
NCT01517087 COMPLETED