AutismNCT01980186
Transcranial Ultrasonography Using Linear 2D Imaging of the Brain
An observational study of Autism and Extra-axial Fluid, run by Brain Treatment Center at 2 sites in United States.
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… Read more about this study
- Who is it for?
- Ages 6 months to 21 yearsHealthy volunteers can take part
- Conditions the study is for
- Autism, Extra-axial Fluid
- What is being tested?
- TUS transcranial 2D ultrasound
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 2 sitesUnited States
- Study dates
- Nov 2013to Nov 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months to 21 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Individuals with autism of any age and their neurotypical otherwise healthy siblings of any included age (6 months to 21 years).
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.
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Exclusion Criteria: Siblings must have no obvious health issues or developmental abnormalities.
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Trial locations and contacts
2 sites in 1 country.
United States2 sites
Brain Treatment Center
Buford, Georgia, 30518
Brain Treatment Center
Newport Beach, California, 92660
About this study
Official title: 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.
Read the 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.
- Conditions
- Autism, Extra-axial Fluid
- Being tested
- TUS transcranial 2D ultrasound
- Keywords
- transcranial ultrasound, autism, cortical dysplasia, extra-axial fluid
- Medical subject headings
- Autistic Disorder, Malformations of Cortical Development
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TUS transcranial 2D ultrasoundDevice
| Study group | Role | What they receive |
|---|---|---|
| Individuals with autism | Both individuals with autism and their siblings will be evaluated with (TUS)transcranial 2D ultrasound. Receives: Device: TUS transcranial 2D ultrasound | |
| Siblings of individuals with autism | Non-autistic siblings with no other obvious health issues will be screened Receives: Device: TUS transcranial 2D ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: This study will collect data for up to 3 years to determine the accuracy of the predictive assessments for autism risk
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2013 (estimated)
- Study startNov 2013
- Primary completionNov 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AutismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brain Treatment Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- James J Bradstreet, MD, Principal investigator, Brain Treatment Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01980186
- Sponsor's protocol ID
- BTC-002
- Status last verified
- Nov 2013
- First submitted
- 4 Nov 2013
- Last updated
- 11 Nov 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcranial Ultrasonography Using Linear 2D Imaging of the Brain and Surrounding Tissues
- ClinicalTrials.gov ID
- NCT01980186
- Acronym / sponsor ID
- BTC-002
- Conditions
- Autism, Extra-axial Fluid
- Keywords
- transcranial ultrasound, autism, cortical dysplasia, extra-axial fluid
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Brain Treatment CenterUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- Nov 2016 (estimated)
- First posted
- 8 Nov 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Individuals with autism | – | Device: TUS transcranial 2D ultrasoundBoth individuals with autism and their siblings will be evaluated with (TUS)transcranial 2D ultrasound. |
| Siblings of individuals with autism | – | Device: TUS transcranial 2D ultrasoundNon-autistic siblings with no other obvious health issues will be screened |
Who may qualify
- Ages
- 6 months to 21 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Individuals with autism of any age and their neurotypical otherwise healthy siblings of any included age (6 months to 21 years).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TUS transcranial 2D ultrasound | Device | Individuals with autism, Siblings of individuals with autism |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Nov 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James J Bradstreet, MD principal investigator
Brain Treatment Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Autism and Extra-axial Fluid, run by Brain Treatment Center at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Nov 2013.