Validation Digital Bio-markers During Sulforaphane Treatment.

June 28, 2023 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

Enrolling by invitation

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Estimated)

10

Phase

  • 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 Backup

Study Locations

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

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

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
Intervention / Treatment
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

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

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)

July 7, 2022

Primary Completion (Estimated)

December 1, 2023

Study Completion (Estimated)

June 30, 2024

Study Registration Dates

First Submitted

July 9, 2020

First Submitted That Met QC Criteria

March 16, 2021

First Posted (Actual)

March 18, 2021

Study Record Updates

Last Update Posted (Actual)

June 29, 2023

Last Update Submitted That Met QC Criteria

June 28, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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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