Ignite Creation Date:
2024-05-06 @ 2:10 AM
Last Modification Date:
2024-10-26 @ 11:14 AM
Study NCT ID:
NCT01980186
Status:
UNKNOWN
Last Update Posted:
2013-11-11
First Post:
2013-11-04
Brief Title:
Transcranial Ultrasonography Using Linear 2D Imaging of the Brain
Sponsor:
Brain Treatment Center
Organization:
Brain Treatment Center
Study Overview
Official Title:
Transcranial Ultrasonography Using Linear 2D Imaging of the Brain and Surrounding Tissues
Status:
UNKNOWN
Status Verified Date:
2013-11
Last Known Status:
ENROLLING_BY_INVITATION
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 EAForsubarachnoid 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None