Transcranial Ultrasonography Using Linear 2D Imaging of the Brain

• Conditions: Autism; Extra-axial Fluid

• Registration Number: NCT01980186
• Lead Sponsor: Brain Treatment Center

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.

Study Timeline

• Status Verified: 2013-11
• Study Start: 2013-11
• Study First Submitted: 2013-11-04
• Study First Submitted QC: 2013-11-04
• Study First Posted: 2013-11-08
• Last Update Submitted: 2013-11-08
• Last Update Posted: 2013-11-11
• Primary Completion: 2016-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Confirmed diagnosis of autism or the sibling thereof and willingness of a parent to consent and where applicable for the individual to assent or consent depending on age.

Exclusion Criteria

Siblings must have no obvious health issues or developmental abnormalities.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Extra-axial fluid as measured at the gyral summit.	This study will collect data for up to 3 years to determine the accuracy of the predictive assessments for autism risk	TUS is performed with linear 2D acoustical outputs in the 10-5MHz range. These are typical for TUS investigations with doppler and the only difference is the linear output of the probe.

Trial Locations

Locations (1)

Brain Treatment Center; 🇺🇸 Buford, Georgia, United States