Transcranial Ultrasonography Using Linear 2D Imaging of the Brain

November 8, 2013 updated by: Brain Treatment Center

Transcranial Ultrasonography Using Linear 2D Imaging of the Brain and Surrounding Tissues

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Newport Beach, California, United States, 92660
        • Brain Treatment Center
    • Georgia
      • Buford, Georgia, United States, 30518
        • Brain Treatment Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 months to 21 years (ADULT, CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Individuals with autism of any age and their neurotypical otherwise healthy siblings of any included age (6 months to 21 years).

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Individuals with autism
Both individuals with autism and their siblings will be evaluated with (TUS)transcranial 2D ultrasound.
Device: TUS transcranial 2D ultrasound
Siblings of individuals with autism
Non-autistic siblings with no other obvious health issues will be screened
Device: TUS transcranial 2D ultrasound

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Extra-axial fluid as measured at the gyral summit.
Time Frame: 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.
This study will collect data for up to 3 years to determine the accuracy of the predictive assessments for autism risk

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Brain Treatment Center

Investigators

  • Principal Investigator: James J Bradstreet, MD, Brain Treatment Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2013

Primary Completion (ANTICIPATED)

November 1, 2016

Study Registration Dates

First Submitted

November 4, 2013

First Submitted That Met QC Criteria

November 4, 2013

First Posted (ESTIMATE)

November 8, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

November 11, 2013

Last Update Submitted That Met QC Criteria

November 8, 2013

Last Verified

November 1, 2013

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • BTC-002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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