## Protocol Section
### Identification Module
**NCT ID:** NCT00956579

**Brief Title:** Sensory and Connectivity Abnormalities in Autism Spectrum Disorders

**Official Title:** MEG/EEG/MRI and Psychophysics Study of Developmental Disorders

#### Organization Study ID Info
**ID:** 2005P001768
#### Organization
**Class:** OTHER
**Full Name:** Massachusetts General Hospital
#### Secondary ID Infos
**ID:** 5R01MH117998
**Link:** https://reporter.nih.gov/quickSearch/5R01MH117998
**Type:** NIH
### Status Module
#### Completion Date
**Date:** 2023-06

**Type:** ESTIMATED

#### Expanded Access Info
**Last Known Status:** RECRUITING
#### Last Update Post Date
**Date:** 2020-09-18

**Type:** ACTUAL

**Last Update Submit Date:** 2020-09-16

**Overall Status:** UNKNOWN

#### Primary Completion Date
**Date:** 2023-06

**Type:** ESTIMATED

#### Start Date
**Date:** 2013-06

**Type:** ACTUAL

**Status Verified Date:** 2020-09

#### Study First Post Date
**Date:** 2009-08-11
**Type:** ESTIMATED
**Study First Submit Date:** 2007-10-23
**Study First Submit QC Date:** 2009-08-10
### Sponsor Collaborators Module

#### Collaborators

**Class:** NIH

**Name:** National Institutes of Health (NIH)

**Class:** NIH

**Name:** National Institute of Mental Health (NIMH)

#### Lead Sponsor

**Class:** OTHER

**Name:** Massachusetts General Hospital

#### Responsible Party

**Investigator Affiliation:** Massachusetts General Hospital

**Investigator Full Name:** Tal Kenet

**Investigator Title:** Associate Professor

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Oversight Has DMC:** False

### Description Module

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

**Detailed Description:** (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 Module

**Conditions:**

- Autism Spectrum Disorder

**Keywords:**

- autism

- autistic

- sensory

- MEG

- connectivity

- brain

- MRI

- language

- developmental

- neurodevelopmental

- aspergers

- asperger's

- coherence

### Design Module

#### Design Info

**Observational Model:** OTHER

**Time Perspective:** OTHER

#### Enrollment Info

**Count:** 120

**Type:** ESTIMATED

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** No intervention

Healthy participants ages 14-32 for a neuroimaging study

**Label:** Healthy individuals

#### Arm Group 2

**Description:** No intervention

ASD participants ages 14-32 for a neuroimaging study.

**Label:** Individuals with Autism Spectrum Disorder

### Outcomes Module

#### Primary Outcomes

**Measure:** Saliency of Sensory Stimuli in Developmental Disorders

**Time Frame:** up to 2 years

### Eligibility Module

**Eligibility Criteria:** 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:

* The following exclusion criteria apply to both control and autism groups:

  * 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.

**Healthy Volunteers:** True

**Maximum Age:** 32 Years

**Minimum Age:** 14 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- CHILD

- ADULT

**Study Population:** Adult/Pediatric

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** TRANSCEND@partners.org

**Name:** Nicole McGuiggan, Rsch Coord

**Phone:** 617-966-9766

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Charlestown

**Country:** United States

**Facility:** Martinos Center or Biomedical Imaging

**State:** Massachusetts

**Status:** RECRUITING

**Zip:** 02129

#### Overall Officials

**Official 1:**

**Affiliation:** Massachusetts General Hospital

**Name:** Tal Kenet, Ph.D

**Role:** PRINCIPAL_INVESTIGATOR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000002659

- Term: Child Development Disorders, Pervasive

- ID: D000065886

- Term: Neurodevelopmental Disorders

- ID: D000001523

- Term: Mental Disorders

### Condition Browse Module - Browse Branches

- Abbrev: BXM

- Name: Behaviors and Mental Disorders

- Abbrev: All

- Name: All Conditions

- Abbrev: BC16

- Name: Diseases and Abnormalities at or Before Birth

### Condition Browse Module - Browse Leaves

- ID: M4623

- Name: Autistic Disorder

- Relevance: HIGH

- As Found: Autism

- ID: M206

- Name: Autism Spectrum Disorder

- Relevance: HIGH

- As Found: Autism Spectrum Disorder

- ID: M12

- Name: Congenital Abnormalities

- Relevance: LOW

- As Found: Unknown

- ID: M5902

- Name: Developmental Disabilities

- Relevance: LOW

- As Found: Unknown

- ID: M5903

- Name: Child Development Disorders, Pervasive

- Relevance: LOW

- As Found: Unknown

- ID: M30644

- Name: Neurodevelopmental Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M4815

- Name: Mental Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M14473

- Name: Psychotic Disorders

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000001321

- Term: Autistic Disorder

- ID: D000067877

- Term: Autism Spectrum Disorder

### Misc Info Module

- Version Holder: 2024-05-24
