Transcranial Ultrasonography Using Linear 2D Imaging of the Brain

NCT ID: NCT01980186

Last Updated: 2013-11-11

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-11-30

Brief Summary

This study will use linear 2D ultrasound imaging to look at the brain of individuals diagnosed with autism and their siblings. This is called transcranial ultrasound (TUS). It is hypothesized that TUS will allow real-time imaging of the fluid spaces outside the brain and will further allow the imagining of brain areas important to language and social function.

Detailed Description

TUS will be evaluated as a simple and low cost screening technique to evaluate the presence of increased extra-axial fluid (EAF)or(subarachnoid cerebral spinal fluid). A recent study (Shen et al. 2013) demonstrated increased EAF was predictive of risk of autism. We believe TUS is capable or rapid, safe, low cost, non-invasive measurement of EAF spaces. Where prior imaging, ie., MRI or CT exist they will be used as comparisons. Both individuals with autism and their siblings will be screened to create a database and standard for TUS measurements. It is further believed that TUS may be able to detect areas of cortical abnormalities called dysplasias. The procedure requires no sedation and only takes a few minutes to perform. If validated, this would make TUS an ideal screening test for autism risk and allow for early referral and more definitive imaging with MRI where necessary.

Conditions

Autism; Extra-axial Fluid

Study Groups

Individuals with autism

Both individuals with autism and their siblings will be evaluated with (TUS)transcranial 2D ultrasound.

TUS transcranial 2D ultrasound

Intervention Type: DEVICE

Siblings of individuals with autism

Non-autistic siblings with no other obvious health issues will be screened

TUS transcranial 2D ultrasound

Intervention Type: DEVICE

Interventions

TUS transcranial 2D ultrasound

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

-

Exclusion Criteria

-

• Minimum Eligible Age: 6 Months
• Maximum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Brain Treatment Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

James J Bradstreet, MD

Role: PRINCIPAL_INVESTIGATOR

Brain Treatment Center

Locations

Brain Treatment Center

Newport Beach, California, United States

Brain Treatment Center

Buford, Georgia, United States

Countries

United States

Other Identifiers

BTC-002

Identifier Type: -

Identifier Source: org_study_id