CLINICAL STUDY FOR AUTISM
MMT has requested IRB approval for the Ped=IO ASD clinical trial to evaluate the effectiveness of early treatments initiated by the early diagnosis of autism spectrum disorder ASD..
The PED=IO ASD MRI Protocol is a non-treatment observational non-blinded clinical study designed to verify recent and very critical findings in ASD Clinical Research:
- In certain children 18-36 months of age in whom the diagnosis of ASD is being considered but not yet verifiable, it may be possible to detect changes in brain function associated with ASD using neuroimaging as an adjunct to standard techniques
- Earlier treatment of ASD can be associated with improved outcomes,
- non-Functional MRI may be equivalent to functional MRI (fMRI) as a neuroimaging tool to validate / support / supplement the diagnosis of ASD at 18-36 months of age, in those cases where there is initial uncertainty in the diagnosis.
The clinical study will follow this general outline :
1. Identification of individuals who may have ASD but who may be considered too young (18-36 months) to be diagnosed.
MMT NeuroTech, working thru clinicians certified in the area of diagnosis of ASD, to confirm a probable diagnosis using a combination of standard psychometric examinations, before proceeding to the next steps. Parents who believe their child fits this description, or their treating primary care doctor PMD, can contact MMT NeuroTech by email info@MilMag.net for consideration of enrollment in this study. MMT NeuroTech encourages autism treatment centers ATC, clinical psychologist involved in autism diagnosis and treatment pediatricians and other interested individuals to contact MMT NeuroTech to arrange for their participation.
2. Specific neuroimaging to confirm the presence of patterns that are highly correlated with presence of ASD in the 18-36 month age group. MMT NeuroTech will work with your PMD to arrange for these tests, and to have the test results, including the raw study data, forwarded to MMT NeuroTech.
3. Initiation of specific treatments for ADS at an early age. MMT NeuroTech will work with your PMD to arrange for the best ASD early treatments for your child.
4. Observation and testing with cognitive tests and neuroimaging over a three year period to demonstrate improve therapeutic outcome when individuals with ASD are diagnosed at an earlier age. Independent of this protocol, MMT can arrange for cognitive testing and neuroimaging at an early age as a separate service.
5. Study participants will remain under the care of their primary or specialty physicians and ATC, and all testing, treatments and billing will take place thru these physicians and ATC, not MMT NeuroTech. MMT NeuroTech is not a health care provider, and does not diagnose or treat ASD or any illness, and does not assume or direct the diagnosis, treatment or care of any study individual.
6. Any costs for testing including neuroimaging, and treatments, remain the responsibility of the study participants. While there is no financial benefit to study participants for participation in this study, there are a number of significant potential benefits.
- it may be possible in the protocol to determine whether ASD can be diagnosed and treatment initiated at an early age.
- The benefits from early diagnosis and treatment may be better treatment outcomes.