Validation Digital Bio-markers During Sulforaphane Treatment.

October 28, 2025 updated by: Elizabeth B. Torres Ph.D., Rutgers, The State University of New Jersey

A Pilot Project to Validate Digital Bio-markers as a Tool to Measure Improvement in Core Symptoms of Autism During Sulforaphane Treatment.

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)).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Enrolling by invitation

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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 (electroencephalogram), EKG (electrocardiogram), kinematics and others. These measures are done at the same time as the clinical evaluations and so results can be compared. Because the data are based on the unique fingerprint-like signatures of the person's nervous systems, it is possible to ascertain the person's progression in response to treatment and compare it to baseline states. The project will also compare these self-emerging clusters between subjects, possibly identifying patterns that correlate with sub-phenotypes or with similarities in response to treatment. Changes in things such as natural behaviors, an individual's ability or desire to interact socially and ability or desire to communicate will alter the signature profiles from baseline. Since these changes are dynamic in nature, trends of the evolving patterns and separate changes that are a consequence of the treatment vs. changes that are part of the natural neurodevelopment can be detected. This may be a valuable tool in future studies of underlying etiology. The technology used to perform these measures and the software to analyze the data are evolving rapidly. Last, with the characterized signatures and possibly overlapping patterns generated in this and in other projects it is foreseeable that a clinically relevant tool for measures in autism will follow.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
10

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • New Jersey
      • Piscataway, New Jersey, United States, 08854
        • Rutgers-RWJMS Department of Neurology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

13 years to 30 years (Child, Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Treatment
All subjects will receive 1.47umol/kg/day sulforaphane for 12 weeks. Pills are taken once a say with a meal.
Dietary supplement: Sulforaphane
Sulforaphane comes from eating certain cruciferous vegetables. In this case the pills are made from broccoli seeds.
Other Names:
  • Avmacol®

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Aberrant Behavior Checklist (ABC)
Time Frame: Baseline.
Rating scale to measure severity aberrant behaviors
Baseline.
Aberrant Behavior Checklist (ABC)
Time Frame: Week 6.
Rating scale to measure severity aberrant behaviors
Week 6.
Aberrant Behavior Checklist (ABC)
Time Frame: Week 12, end of treatment.
Rating scale to measure severity aberrant behaviors
Week 12, end of treatment.
Aberrant Behavior Checklist (ABC)
Time Frame: Week 16.
Rating scale to measure severity aberrant behaviors
Week 16.
Social Responsiveness Scale (SRS)
Time Frame: Baseline.
Rating scale to measure social interaction.
Baseline.
Social Responsiveness Scale (SRS)
Time Frame: Week 6.
Rating scale to measure social interaction.
Week 6.
Social Responsiveness Scale (SRS)
Time Frame: Week 12, end of treatment.
Rating scale to measure social interaction.
Week 12, end of treatment.
Social Responsiveness Scale (SRS)
Time Frame: Week 16.
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)
Time Frame: Baseline.
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)
Time Frame: Week 6.
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)
Time Frame: Week 12, end of treatment.
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)
Time Frame: Week 16.
Rating scale to measure autism severity and changes in severity.
Week 16.
Digital Biomarkers
Time Frame: Baseline.
Non-invasive biosensor measurements of micro-movements.
Baseline.
Digital Biomarkers
Time Frame: Week 6.
Non-invasive biosensor measurements of micro-movements.
Week 6.
Digital Biomarkers
Time Frame: Week 12, end of treatment.
Non-invasive biosensor measurements of micro-movements.
Week 12, end of treatment.
Digital Biomarkers
Time Frame: Week 16.
Non-invasive biosensor measurements of micro-movements.
Week 16.
EEG
Time Frame: Baseline
Electroencephalogram (EEG) measures electrical activity of the brain.
Baseline
EEG
Time Frame: Week 6.
Electroencephalogram (EEG) measures electrical activity of the brain.
Week 6.
EEG
Time Frame: Week 12, end of treatment.
Electroencephalogram (EEG) measures electrical activity of the brain.
Week 12, end of treatment.
EEG
Time Frame: Week 16.
Electroencephalogram (EEG) measures electrical activity of the brain.
Week 16.
EKG
Time Frame: Baseline
Electrocardiogram (ECG or EKG) measures electrical signals from the heart.
Baseline
EKG
Time Frame: Week 6.
Electrocardiogram (ECG or EKG) measures electrical signals from the heart.
Week 6.
EKG
Time Frame: Week 12, end of treatment.
Electrocardiogram (ECG or EKG) measures electrical signals from the heart.
Week 12, end of treatment.
EKG
Time Frame: Week 16.
Electrocardiogram (ECG or EKG) measures electrical signals from the heart.
Week 16.
Electrophysiological recordings.
Time Frame: Baseline
Measurement of electrical activity in Tissue.
Baseline
Electrophysiological recordings.
Time Frame: Week 6.
Measurement of electrical activity in Tissue.
Week 6.
Electrophysiological recordings.
Time Frame: Week 12, end of treatment.
Measurement of electrical activity in Tissue.
Week 12, end of treatment.
Electrophysiological recordings.
Time Frame: Week 16.
Measurement of electrical activity in Tissue.
Week 16.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Rutgers, The State University of New Jersey

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 7, 2022

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 9, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 16, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 18, 2021

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 30, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 28, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Pro2019001854

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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