AutismNCT04805957
Validation Digital Bio-markers During Sulforaphane Treatment.
A study testing Sulforaphane in people with Autism and Autism Spectrum Disorder, run by Rutgers, The State University of New Jersey at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 13 to 30 years, men only
- Conditions the study is for
- Autism, Autism Spectrum Disorder, Autistic Disorder
- What is being tested?
- Sulforaphane
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Jul 2022to 1 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 30 years
- Men only
- No healthy volunteers
- Child, Adult
Who may be able to join
- Autistic disorder diagnosis.
- Age between 13-30 years.
- Male gender.
- Participated in clinical trial NCT02677051
Who cannot join
- 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).
Show all 13Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Rutgers-RWJMS Department of Neurology
Piscataway, New Jersey, 08854
About this study
Official title: 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)).
Read the 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.
- Conditions
- Autism, Autism Spectrum Disorder, Autistic Disorder
- Being tested
- Sulforaphane
- Keywords
- Sulforaphane
- Medical subject headings
- Autistic Disorder, Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SulforaphaneDietary supplement
Also called Avmacol®
Sulforaphane comes from eating certain cruciferous vegetables. In this case the pills are made from broccoli seeds.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | All subjects will receive 1.47umol/kg/day sulforaphane for 12 weeks. Pills are taken once a say with a meal. Receives: Dietary Supplement: Sulforaphane |
What is being measured
The primary outcome is the main question the study is designed to answer.
Aberrant Behavior Checklist (ABC)
Rating scale to measure severity aberrant behaviors
Measured: Baseline.
Aberrant Behavior Checklist (ABC)
Rating scale to measure severity aberrant behaviors
Measured: Week 6.
Aberrant Behavior Checklist (ABC)
Rating scale to measure severity aberrant behaviors
Measured: Week 12, end of treatment.
Aberrant Behavior Checklist (ABC)
Rating scale to measure severity aberrant behaviors
Measured: Week 16.
Social Responsiveness Scale (SRS)
Rating scale to measure social interaction.
Measured: Baseline.
Social Responsiveness Scale (SRS)
Rating scale to measure social interaction.
Measured: Week 6.
Social Responsiveness Scale (SRS)
Rating scale to measure social interaction.
Measured: Week 12, end of treatment.
Social Responsiveness Scale (SRS)
Rating scale to measure social interaction.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Week 16.
Digital Biomarkers
Non-invasive biosensor measurements of micro-movements.
Measured: Baseline.
Digital Biomarkers
Non-invasive biosensor measurements of micro-movements.
Measured: Week 6.
Digital Biomarkers
Non-invasive biosensor measurements of micro-movements.
Measured: Week 12, end of treatment.
Digital Biomarkers
Non-invasive biosensor measurements of micro-movements.
Measured: Week 16.
EEG
Electroencephalogram (EEG) measures electrical activity of the brain.
Measured: Baseline
EEG
Electroencephalogram (EEG) measures electrical activity of the brain.
Measured: Week 6.
EEG
Electroencephalogram (EEG) measures electrical activity of the brain.
Measured: Week 12, end of treatment.
EEG
Electroencephalogram (EEG) measures electrical activity of the brain.
Measured: Week 16.
EKG
Electrocardiogram (ECG or EKG) measures electrical signals from the heart.
Measured: Baseline
EKG
Electrocardiogram (ECG or EKG) measures electrical signals from the heart.
Measured: Week 6.
EKG
Electrocardiogram (ECG or EKG) measures electrical signals from the heart.
Measured: Week 12, end of treatment.
EKG
Electrocardiogram (ECG or EKG) measures electrical signals from the heart.
Measured: Week 16.
Electrophysiological recordings.
Measurement of electrical activity in Tissue.
Measured: Baseline
Electrophysiological recordings.
Measurement of electrical activity in Tissue.
Measured: Week 6.
Electrophysiological recordings.
Measurement of electrical activity in Tissue.
Measured: Week 12, end of treatment.
Electrophysiological recordings.
Measurement of electrical activity in Tissue.
Measured: Week 16.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2021
- Study start7 Jul 2022
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for AutismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a 12 week open label trial.
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rutgers, The State University of New Jersey
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elizabeth B. Torres Ph.D., Rutgers, The State University of New Jersey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04805957
- Sponsor's protocol ID
- Pro2019001854
- Status last verified
- Oct 2025
- First submitted
- 9 Jul 2020
- Last updated
- 30 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 25313065Torres 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.
PubMed 23898241Torres 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.
PubMed 22587379
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Project to Validate Digital Bio-markers as a Tool to Measure Improvement in Core Symptoms of Autism During Sulforaphane Treatment.
- ClinicalTrials.gov ID
- NCT04805957
- Acronym / sponsor ID
- Pro2019001854
- Conditions
- Autism, Autism Spectrum Disorder, Autistic Disorder
- Keywords
- Sulforaphane
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Rutgers, The State University of New JerseyUniversity, hospital or other
- Study start
- 7 Jul 2022 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 18 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)).
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a 12 week open label trial.
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Dietary Supplement: SulforaphaneAll subjects will receive 1.47umol/kg/day sulforaphane for 12 weeks. Pills are taken once a say with a meal. |
Who may qualify
- Ages
- 13 to 30 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Autistic disorder diagnosis.
- Age between 13-30 years.
- Male gender.
- Participated in clinical trial NCT02677051
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SulforaphaneAlso: Avmacol®Sulforaphane comes from eating certain cruciferous vegetables. In this case the pills are made from broccoli seeds. | Dietary supplement | Treatment |
Primary outcome
Aberrant Behavior Checklist (ABC)
Time frame: Baseline.
Rating scale to measure severity aberrant behaviors
Aberrant Behavior Checklist (ABC)
Time frame: Week 6.
Rating scale to measure severity aberrant behaviors
Aberrant Behavior Checklist (ABC)
Time frame: Week 12, end of treatment.
Rating scale to measure severity aberrant behaviors
Aberrant Behavior Checklist (ABC)
Time frame: Week 16.
Rating scale to measure severity aberrant behaviors
Social Responsiveness Scale (SRS)
Time frame: Baseline.
Rating scale to measure social interaction.
Social Responsiveness Scale (SRS)
Time frame: Week 6.
Rating scale to measure social interaction.
Social Responsiveness Scale (SRS)
Time frame: Week 12, end of treatment.
Rating scale to measure social interaction.
Social Responsiveness Scale (SRS)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: Week 16.
Rating scale to measure autism severity and changes in severity.
Digital Biomarkers
Time frame: Baseline.
Non-invasive biosensor measurements of micro-movements.
Digital Biomarkers
Time frame: Week 6.
Non-invasive biosensor measurements of micro-movements.
Digital Biomarkers
Time frame: Week 12, end of treatment.
Non-invasive biosensor measurements of micro-movements.
Digital Biomarkers
Time frame: Week 16.
Non-invasive biosensor measurements of micro-movements.
EEG
Time frame: Baseline
Electroencephalogram (EEG) measures electrical activity of the brain.
EEG
Time frame: Week 6.
Electroencephalogram (EEG) measures electrical activity of the brain.
EEG
Time frame: Week 12, end of treatment.
Electroencephalogram (EEG) measures electrical activity of the brain.
EEG
Time frame: Week 16.
Electroencephalogram (EEG) measures electrical activity of the brain.
EKG
Time frame: Baseline
Electrocardiogram (ECG or EKG) measures electrical signals from the heart.
EKG
Time frame: Week 6.
Electrocardiogram (ECG or EKG) measures electrical signals from the heart.
EKG
Time frame: Week 12, end of treatment.
Electrocardiogram (ECG or EKG) measures electrical signals from the heart.
EKG
Time frame: Week 16.
Electrocardiogram (ECG or EKG) measures electrical signals from the heart.
Electrophysiological recordings.
Time frame: Baseline
Measurement of electrical activity in Tissue.
Electrophysiological recordings.
Time frame: Week 6.
Measurement of electrical activity in Tissue.
Electrophysiological recordings.
Time frame: Week 12, end of treatment.
Measurement of electrical activity in Tissue.
Electrophysiological recordings.
Time frame: Week 16.
Measurement of electrical activity in Tissue.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2025.
- Background: PubMed 25313065Singh 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.
- Background: PubMed 23898241Torres 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.
- Background: PubMed 22587379Torres 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sulforaphane in people with Autism and Autism Spectrum Disorder, run by Rutgers, The State University of New Jersey at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 30 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Aberrant Behavior Checklist (ABC) (time frame: Baseline.). The study lists 28 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04805957, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2025.