NCT04805957

Brief Summary

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)).

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
13mo left

Started Jul 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress78%
Jul 2022Jun 2027

First Submitted

Initial submission to the registry

July 9, 2020

Completed
8 months until next milestone

First Posted

Study publicly available on registry

March 18, 2021

Completed
1.3 years until next milestone

Study Start

First participant enrolled

July 7, 2022

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2027

Last Updated

October 30, 2025

Status Verified

October 1, 2025

Enrollment Period

4.4 years

First QC Date

July 9, 2020

Last Update Submit

October 28, 2025

Conditions

AutismAutism Spectrum DisorderAutistic Disorder

Keywords

Sulforaphane

Outcome Measures

Primary Outcomes (28)

  • Aberrant Behavior Checklist (ABC)

    Rating scale to measure severity aberrant behaviors

    Baseline.

  • Aberrant Behavior Checklist (ABC)

    Rating scale to measure severity aberrant behaviors

    Week 6.

  • Aberrant Behavior Checklist (ABC)

    Rating scale to measure severity aberrant behaviors

    Week 12, end of treatment.

  • Aberrant Behavior Checklist (ABC)

    Rating scale to measure severity aberrant behaviors

    Week 16.

  • Social Responsiveness Scale (SRS)

    Rating scale to measure social interaction.

    Baseline.

  • Social Responsiveness Scale (SRS)

    Rating scale to measure social interaction.

    Week 6.

  • Social Responsiveness Scale (SRS)

    Rating scale to measure social interaction.

    Week 12, end of treatment.

  • Social Responsiveness Scale (SRS)

    Rating scale to measure social interaction.

    Week 16.

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

    Rating scale to measure autism severity and changes in severity.

    Baseline.

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

    Rating scale to measure autism severity and changes in severity.

    Week 6.

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

    Rating scale to measure autism severity and changes in severity.

    Week 12, end of treatment.

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

    Rating scale to measure autism severity and changes in severity.

    Week 16.

  • Digital Biomarkers

    Non-invasive biosensor measurements of micro-movements.

    Baseline.

  • Digital Biomarkers

    Non-invasive biosensor measurements of micro-movements.

    Week 6.

  • Digital Biomarkers

    Non-invasive biosensor measurements of micro-movements.

    Week 12, end of treatment.

  • Digital Biomarkers

    Non-invasive biosensor measurements of micro-movements.

    Week 16.

  • EEG

    Electroencephalogram (EEG) measures electrical activity of the brain.

    Baseline

  • EEG

    Electroencephalogram (EEG) measures electrical activity of the brain.

    Week 6.

  • EEG

    Electroencephalogram (EEG) measures electrical activity of the brain.

    Week 12, end of treatment.

  • EEG

    Electroencephalogram (EEG) measures electrical activity of the brain.

    Week 16.

  • EKG

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

    Baseline

  • EKG

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

    Week 6.

  • EKG

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

    Week 12, end of treatment.

  • EKG

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

    Week 16.

  • Electrophysiological recordings.

    Measurement of electrical activity in Tissue.

    Baseline

  • Electrophysiological recordings.

    Measurement of electrical activity in Tissue.

    Week 6.

  • Electrophysiological recordings.

    Measurement of electrical activity in Tissue.

    Week 12, end of treatment.

  • Electrophysiological recordings.

    Measurement of electrical activity in Tissue.

    Week 16.

Study Arms (1)

Treatment

EXPERIMENTAL

All subjects will receive 1.47umol/kg/day sulforaphane for 12 weeks. Pills are taken once a say with a meal.

Dietary Supplement: Sulforaphane

Interventions

SulforaphaneDIETARY_SUPPLEMENT

Sulforaphane comes from eating certain cruciferous vegetables. In this case the pills are made from broccoli seeds.

Also known as: Avmacol®
Treatment

Eligibility Criteria

Age13 Years - 30 Years
Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rutgers-RWJMS Department of Neurology

Piscataway, New Jersey, 08854, United States

Location

Related Publications (3)

  • Singh K, Connors SL, Macklin EA, Smith KD, Fahey JW, Talalay P, Zimmerman AW. Sulforaphane treatment of autism spectrum disorder (ASD). Proc Natl Acad Sci U S A. 2014 Oct 28;111(43):15550-5. doi: 10.1073/pnas.1416940111. Epub 2014 Oct 13.

    PMID: 25313065BACKGROUND

  • Torres EB, Brincker M, Isenhower RW, Yanovich P, Stigler KA, Nurnberger JI, Metaxas DN, Jose JV. Autism: the micro-movement perspective. Front Integr Neurosci. 2013 Jul 24;7:32. doi: 10.3389/fnint.2013.00032. eCollection 2013.

    PMID: 23898241BACKGROUND

  • Torres EB. Atypical signatures of motor variability found in an individual with ASD. Neurocase. 2013 Apr;19(2):150-65. doi: 10.1080/13554794.2011.654224. Epub 2012 May 16.

    PMID: 22587379BACKGROUND

MeSH Terms

Conditions

Autistic DisorderAutism Spectrum Disorder

Interventions

sulforaphane

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: This is a 12 week open label trial.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Psychology

Study Record Dates

First Submitted

July 9, 2020

First Posted

March 18, 2021

Study Start

July 7, 2022

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

June 1, 2027

Last Updated

October 30, 2025

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)