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Transcranial Ultrasonography Using Linear 2D Imaging of the Brain

NCT ID: NCT01980186

Last Updated: 2013-11-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-11-30

Brief Summary

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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

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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

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Autism Extra-axial Fluid

Keywords

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transcranial ultrasound autism cortical dysplasia extra-axial fluid

Study Groups

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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

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TUS transcranial 2D ultrasound

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

\-

Exclusion Criteria

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Minimum Eligible Age

6 Months

Maximum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Brain Treatment Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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James J Bradstreet, MD

Role: PRINCIPAL_INVESTIGATOR

Brain Treatment Center

Locations

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Brain Treatment Center

Newport Beach, California, United States

Site Status

Brain Treatment Center

Buford, Georgia, United States

Site Status

Countries

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United States

Other Identifiers

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BTC-002

Identifier Type: -

Identifier Source: org_study_id