Validation Digital Bio-markers During Sulforaphane Treatment.

Launched by RUTGERS, THE STATE UNIVERSITY OF NEW JERSEY · Mar 16, 2021

Keywords

ClinConnect Summary

This study is a pilot open label treatment trial with SF (sulforaphane) in 10 individuals that have completed with moderate to severe autism, age 13-30 years that have completed participation in ClinicalTrials.gov Identifier: NCT02677051. This study will measure digital biomarkers of the nervous systems. Digital biomarkers are obtained by using non-invasive wireless (wearable, like wearing a watch) biosensors that co-register in tandem multiple biorhythms self-generated by the person's nervous systems. These sensors gather a very large amount of data from measures such as EEG (electroenceph...

Gender

MALE

Eligibility criteria

• Inclusion Criteria:
• • Autistic disorder diagnosis.
• • Age between 13-30 years.
• • Male gender.
• • Participated in clinical trial NCT02677051
• Exclusion Criteria:
• • Those that started or continued taking Avmacol® or similar broccoli extracts since leaving our double-blind study.
• • Absence of a parent or legal guardian and consent,
• • Those that can not or will not complete all visits and adherence to study regimen.
• • Seizure within 2 years of screening,
• • History of chronic kidney, liver or thyroid disease.
• • Impaired renal function (serum creatinine\> 1.2 mg/dl).
• • Impaired hepatic function (\> 2x upper limit of normal).
• • Impaired thyroid function (TSH outside normal limits).
• • Current infection or treatment with antibiotics.
• • Chronic medical disorder (e.g., cardiovascular disease, stroke or diabetes) or major surgery within 3 months prior to enrollment.
• • Less than 13 years or more than 30 years of age.
• • Female gender.
• • A diagnosis of autism spectrum disorder other than autistic disorder, for example, Asperger, PDD-NOS ( Pervasive Developmental Disorder-Not Otherwise Specified) etc.