Transcranial Ultrasonography Using Linear 2D Imaging of the Brain

Autism Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT01980186
• Other study ID #: BTC-002
• Status: Enrolling by invitation
• Phase: N/A
• First received: November 4, 2013
• Last updated: November 8, 2013
• Start date: November 2013

Study information

• Verified date: November 2013
• Source: Brain Treatment Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 100
• Est. primary completion date: November 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 6 Months to 21 Years

Eligibility

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

N/A

Related Conditions & MeSH terms

• Autism
• Extra-axial Fluid

Intervention

Device:
• TUS transcranial 2D ultrasound

Locations

Country	Name	City	State
United States	Brain Treatment Center	Buford	Georgia
United States	Brain Treatment Center	Newport Beach	California

Sponsors (1)

Lead Sponsor	Collaborator
Brain Treatment Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Extra-axial fluid as measured at the gyral summit.	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	No