Validation Digital Bio-markers During Sulforaphane Treatment.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-07

Study Completion Date

2027-06-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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)).

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Effects of 2 Different Broccoli Sprout Containing Supplements on Nasal Cells in Healthy Volunteers

NCT01129466

Healthy Adult Volunteers

COMPLETED NA

An Open Study of Sulforaphane-rich Broccoli Sprout Extract in Patients With Schizophrenia

NCT01716858

Schizophrenia

COMPLETED PHASE2

An Open Label Study Evaluating the Effectiveness of Omega Q Plus® Resveratrol at Increasing Blood Levels of CoQ10

NCT02415114

CoQ10 Blood Levels CoQ10 Blood Levels With Statin Use

COMPLETED PHASE1

Evaluating Whole Foods Supplementation on Cognition

NCT01672359

Sub-optimal Cognitive Function Sub-optimal Immune Function

COMPLETED NA

Study to Evaluate the Effect of Sulforaphane in Broccoli Sprout Extract on Breast Tissue

NCT00982319

Breast Cancer

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Autism Autism Spectrum Disorder Autistic Disorder

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

This is a 12 week open label trial.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Treatment

All subjects will receive 1.47umol/kg/day sulforaphane for 12 weeks. Pills are taken once a say with a meal.

Group Type EXPERIMENTAL

Sulforaphane

Intervention Type DIETARY_SUPPLEMENT

Sulforaphane comes from eating certain cruciferous vegetables. In this case the pills are made from broccoli seeds.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Sulforaphane

Sulforaphane comes from eating certain cruciferous vegetables. In this case the pills are made from broccoli seeds.

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Avmacol®

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

13 Years

Maximum Eligible Age

30 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No