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Sulforaphane Treatment and Digital Biomarkers in Autism

This study is exploring if digital biomarkers, like heart rate and muscle movement measured by wearable devices, can help us better understand how people with autism respond to sulforaphane treatment. Sulforaphane is a compound found in certain vegetables, and in this study, it's given as pills made from broccoli seeds. This research is for men aged 13 to 30 who have an autism diagnosis and have previously participated in a specific clinical trial (NCT02677051). The study will measure changes in behavior using the Aberrant Behavior Checklist (ABC) at the beginning, after 6 weeks, and at the end of 12 weeks of treatment. The current recruitment status is unclear.

Study design
This is a pilot, open-label (meaning both researchers and participants know the treatment) study with 10 participants.
What's involved
You would take sulforaphane and have your behavior assessed at baseline, week 6, and week 12. You would also wear non-invasive devices to collect digital biomarker data.
Compensation
Not stated in the trial record.
Follow-up
The study measures outcomes up to 12 weeks, which is the end of treatment.

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NCT04805957

Validation Digital Bio-markers During Sulforaphane Treatment.

Enrolling by Invitation
NAAges 13–30InterventionalTreatment
Rutgers, The State University of New Jersey
~10 participants
Updated 2025-10-30 on ClinicalTrials.gov
What's tested:Sulforaphane

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Aberrant Behavior Checklist (ABC)
Measured over Baseline.
+27 more outcomes measured

Conditions

Autism
Autism Spectrum Disorder
Autistic Disorder

Explore related trials

Autism

Where it's being run

1 sites across 1 states
New Jersey1

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

Exclusion

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.

What this trial measures

  • Aberrant Behavior Checklist (ABC)Baseline.

    Rating scale to measure severity aberrant behaviors

  • Aberrant Behavior Checklist (ABC)Week 6.

    Rating scale to measure severity aberrant behaviors

  • Aberrant Behavior Checklist (ABC)Week 12, end of treatment.

    Rating scale to measure severity aberrant behaviors

  • Aberrant Behavior Checklist (ABC)Week 16.

    Rating scale to measure severity aberrant behaviors

  • Social Responsiveness Scale (SRS)Baseline.

    Rating scale to measure social interaction.

  • Social Responsiveness Scale (SRS)Week 6.

    Rating scale to measure social interaction.

  • Social Responsiveness Scale (SRS)Week 12, end of treatment.

    Rating scale to measure social interaction.

  • Social Responsiveness Scale (SRS)Week 16.

    Rating scale to measure social interaction.

  • Ohio Autism Clinical Global Impression Scale - Severity (OACIS-S, an autism specific version of the Clinical Global Impression, CGI)Baseline.

    Rating scale to measure autism severity and changes in severity.

  • Ohio Autism Clinical Global Impression Scale - Severity (OACIS-S, an autism specific version of the Clinical Global Impression, CGI)Week 6.

    Rating scale to measure autism severity and changes in severity.

  • Ohio Autism Clinical Global Impression Scale - Severity (OACIS-S, an autism specific version of the Clinical Global Impression, CGI)Week 12, end of treatment.

    Rating scale to measure autism severity and changes in severity.

  • Ohio Autism Clinical Global Impression Scale - Severity (OACIS-S, an autism specific version of the Clinical Global Impression, CGI)Week 16.

    Rating scale to measure autism severity and changes in severity.

  • Digital BiomarkersBaseline.

    Non-invasive biosensor measurements of micro-movements.

  • Digital BiomarkersWeek 6.

    Non-invasive biosensor measurements of micro-movements.

  • Digital BiomarkersWeek 12, end of treatment.

    Non-invasive biosensor measurements of micro-movements.

  • Digital BiomarkersWeek 16.

    Non-invasive biosensor measurements of micro-movements.

  • EEGBaseline

    Electroencephalogram (EEG) measures electrical activity of the brain.

  • EEGWeek 6.

    Electroencephalogram (EEG) measures electrical activity of the brain.

  • EEGWeek 12, end of treatment.

    Electroencephalogram (EEG) measures electrical activity of the brain.

  • EEGWeek 16.

    Electroencephalogram (EEG) measures electrical activity of the brain.

  • EKGBaseline

    Electrocardiogram (ECG or EKG) measures electrical signals from the heart.

  • EKGWeek 6.

    Electrocardiogram (ECG or EKG) measures electrical signals from the heart.

  • EKGWeek 12, end of treatment.

    Electrocardiogram (ECG or EKG) measures electrical signals from the heart.

  • EKGWeek 16.

    Electrocardiogram (ECG or EKG) measures electrical signals from the heart.

  • Electrophysiological recordings.Baseline

    Measurement of electrical activity in Tissue.

  • Electrophysiological recordings.Week 6.

    Measurement of electrical activity in Tissue.

  • Electrophysiological recordings.Week 12, end of treatment.

    Measurement of electrical activity in Tissue.

  • Electrophysiological recordings.Week 16.

    Measurement of electrical activity in Tissue.