Validation Digital Bio-markers During Sulforaphane Treatment.

Enrolling by invitation · Not applicable

Conditions studied: Autism, Autism Spectrum Disorder, Autistic Disorder

In brief

The purpose of the research is to determine if changes seen during sulforaphane treatment (a compound that comes from eating certain vegetables) can better be understood using digital biomarkers. These digital biomarkers are things like heart rate, muscle movement etc. and are measured using non-invasive devices (like a watch) and are aimed at complementing the traditional clinical scores already in use in current trials (e.g. Aberrant Behavior Checklist (ABC), Social Responsiveness Scale (SRS) and Ohio Autism Clinical Impressions Scale (OACIS)).

Key facts

Study ID

NCT04805957

Run by

Rutgers, The State University of New Jersey

People needed

10

Starts

2022-07-07

Expected to finish

2027-06-01

Last updated by the study team

2025-10-30

Who can join

Age: 13 and older, up to 30. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• Autistic disorder diagnosis.
• Age between 13-30 years.
• Male gender.
• Participated in clinical trial NCT02677051

You may not qualify if…

• 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.

Where it is running

• Rutgers-RWJMS Department of Neurology — Piscataway, New Jersey, United States

Full record on ClinicalTrials.gov

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