Clinical trial NCT04805957: Validation Digital Bio-markers During Sulforaphane Treatment.
Official title: A Pilot Project to Validate Digital Bio-markers as a Tool to Measure Improvement in Core Symptoms of Autism During Sulforaphane Treatment.
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Autism
Autism Spectrum Disorder
Autistic Disorder
Keywords: Sulforaphane
Lead sponsor: Rutgers, The State University of New Jersey
Sponsor class: OTHER
First posted: 2021-03-18
Enrollment: 10
Sex: MALE
Minimum age (years): 13
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This is a 12 week open label trial.
Primary purpose: TREATMENT

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)).

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Aberrant Behavior Checklist (ABC)
timeFrame: Baseline.
measure: Aberrant Behavior Checklist (ABC)
timeFrame: Week 6.
measure: Aberrant Behavior Checklist (ABC)
timeFrame: Week 12, end of treatment.
measure: Aberrant Behavior Checklist (ABC)
timeFrame: Week 16.
measure: Social Responsiveness Scale (SRS)
timeFrame: Baseline.
measure: Social Responsiveness Scale (SRS)
timeFrame: Week 6.
measure: Social Responsiveness Scale (SRS)
timeFrame: Week 12, end of treatment.
measure: Social Responsiveness Scale (SRS)
timeFrame: Week 16.
measure: Ohio Autism Clinical Global Impression Scale - Severity (OACIS-S, an autism specific version of the Clinical Global Impression, CGI)
timeFrame: Baseline.
measure: Ohio Autism Clinical Global Impression Scale - Severity (OACIS-S, an autism specific version of the Clinical Global Impression, CGI)
timeFrame: Week 6.
measure: Ohio Autism Clinical Global Impression Scale - Severity (OACIS-S, an autism specific version of the Clinical Global Impression, CGI)
timeFrame: Week 12, end of treatment.
measure: Ohio Autism Clinical Global Impression Scale - Severity (OACIS-S, an autism specific version of the Clinical Global Impression, CGI)
timeFrame: Week 16.
measure: Digital Biomarkers
timeFrame: Baseline.
measure: Digital Biomarkers
timeFrame: Week 6.
measure: Digital Biomarkers
timeFrame: Week 12, end of treatment.
measure: Digital Biomarkers
timeFrame: Week 16.
measure: EEG
timeFrame: Baseline
measure: EEG
timeFrame: Week 6.
measure: EEG
timeFrame: Week 12, end of treatment.
measure: EEG
timeFrame: Week 16.
measure: EKG
timeFrame: Baseline
measure: EKG
timeFrame: Week 6.
measure: EKG
timeFrame: Week 12, end of treatment.
measure: EKG
timeFrame: Week 16.
measure: Electrophysiological recordings.
timeFrame: Baseline
measure: Electrophysiological recordings.
timeFrame: Week 6.
measure: Electrophysiological recordings.
timeFrame: Week 12, end of treatment.
measure: Electrophysiological recordings.
timeFrame: Week 16.
Secondary outcomes:
Other outcomes:
Locations:
city: Piscataway
country: United States
facility: Rutgers-RWJMS Department of Neurology
state: New Jersey
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.