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NCT04805957Enrolling by invitation

Validation Digital Bio-markers During Sulforaphane Treatment.

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

Source: ClinicalTrials.gov · Last updated 30 Oct 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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)).

Status (registry)
Enrolling by invitation
Study type
Interventional
Enrollment
10 (estimated)
First submitted
9 Jul 2020
Start date
7 Jul 2022
Primary completion date
1 Dec 2026
Lead sponsor
Rutgers, The State University of New Jersey
Diseases
Autism
NCT number
NCT04805957

What you commit to

  • Study type: Interventional
  • Planned participants: 10
  • From 7 Jul 2022 to the primary completion date, 1 Dec 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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.

Other illness

  • Seizure within 2 years of screening,
  • History of chronic kidney, liver or thyroid disease.
  • A diagnosis of autism spectrum disorder other than autistic disorder, for example, Asperger, PDD-NOS ( Pervasive Developmental Disorder-Not Otherwise Specified) etc.

Lab values

  • Impaired renal function (serum creatinine\> 1.2 mg/dl).

Age

  • Less than 13 years or more than 30 years of age.

Other

  • 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.
  • Impaired hepatic function (\> 2x upper limit of normal).
  • Impaired thyroid function (TSH outside normal limits).
  • Female gender.

Who the study is looking for

  • Autistic disorder diagnosis.
  • Age between 13-30 years.
  • Male gender.
  • Participated in clinical trial NCT02677051

Age in the registry: 13 years to 30 years · Sex: Male · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Rutgers-RWJMS Department of Neurology
Coordinator of this site? Confirm its status
PiscatawayUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.