AzTrials
AzTrials

Autism Spectrum Disorder (ASD)RnRNCT04860986

A Repeatability and Reproducibility Study of the EarliPoint™ Device

An observational study of Autism Spectrum Disorder (ASD), run by EarliTec Diagnostics, Inc at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The study is a prospective randomized repeatability and reproducibility (R\&R) study of the EarliPoint DeviceTM in pediatric subjects 16-30 months of age. The study will enroll subjects who are both clinically-positive and clinically-negative for ASD. The study will be conducted at a single center in the US. Read more about this study

Who is it for?
Ages 16 to 30 months
Conditions the study is for
Autism Spectrum Disorder (ASD)
What is being tested?
EarliPoint
Type of treatment
Medical device
How many people
45 participants
Where
1 siteUnited States
Study dates
7 May 2021to 17 Nov 2021
Phase
Observational
Are there results?
None posted in the registry

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 16 to 30 months
  • All sexes
  • No healthy volunteers
  • Child

Study population: Toddlers and young children will be enrolled in this study, as the aim of this research is to examine repeatability of eye-tracking measures in children aged 16-30 months. Precautions will be taken when working with young children. Our clinicians and research staff are well trained and experienced in working with children and families with some level of anxiety. All subject's parent or legal guardian will be consented to the study. No protocol-specific procedures, including screening, will be performed until the parent has signed and dated the consent form. Subjects will also satisfy the inclusion and exclusion criteria in order to be enrolled in the study.

Who may be able to join

  • Children between 16 and 30 months of age.
  • No acute illnesses by physical observation.
  • Normal or corrected-to-normal vision, and normal or corrected-to-normal hearing.
  • Communicate meaningfully with patent in English, and the principal investigator /the study team.
  • Parent or legal guardian is able to read and understand the Informed Consent Form.
  • Parent voluntarily provides written informed consent.

Who cannot join

  • Genetic disorders (e.g., Fragile X, Williams Syndrome, Tuberous Sclerosis, muscular Dystrophy, Neurofibromatosis, Down Syndrome).
  • History or presence of a clinically significant medical disease or a mental state that might confound the study result as assessed by the investigator, such as severe hearing or visual impairment; or uncontrolled epilepsy or seizure disorder, et al.
  • Acute exacerbations of chronic illnesses likely to prevent successful data collection.
  • Receiving therapies that may affect vision.
  • Therapies that may affect the ability to focus.
  • Known allergies or sensitivity to the plastic, leather, or metal components.
  • Unable or unwilling to sit in a child safety seat.
  • Use of any investigational drug, therapies or diagnostic device within the past 14 days.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Emory University

    Atlanta, Georgia, 30329

Other trials in United States

About this study

Official title: A Repeatability and Reproducibility Study of the EarliPoint™ Device in Pediatric Subjects 16-30 Months of Age

The study is a prospective randomized repeatability and reproducibility (R\&R) study of the EarliPoint DeviceTM in pediatric subjects 16-30 months of age. The study will enroll subjects who are both clinically-positive and clinically-negative for ASD.

The study will be conducted at a single center in the US. The Study consists of a screening period in order to review the subject's medical history to determine subject eligibility, followed by a device administration period during which subjects will undergo testing with the EarliPoint Devices and Expert Clinician Diagnosis (ECD) procedures to determine if they are clinically-positive or clinically-negative for ASD.

Read the detailed description

Subjects will undergo testing with the same two (2) devices, with one (1) testing session per device per subject, with each testing session yielding three (3) measurements per endpoint per subject, for a total of six (6) measurements per endpoint for each subject enrolled. The order in which the subjects receive testing with each device will be randomized so that the same device is not always used first or last for each subject.

The primary objectives of this study are to quantify the repeatability variability and reproducibility variability of all of the EarliPoint device's continuous valued outputs: the underlying continuous score used to classify patients into the binary diagnostic classification of either clinically-positive or clinically-negative for autism spectrum disorder (ASD) as well as each of the three EarliPoint Device severity scores (the social disability index, verbal ability index, and nonverbal ability index).

The secondary objectives of this study are to quantify the repeatability and reproducibility variability in producing each of the three EarliPoint Device severity scores: the social disability index, verbal ability index, and nonverbal ability index.

Being tested
EarliPoint
Keywords
EarliPoint, Pediatric, Diagnosis
Medical subject headings
Autism Spectrum Disorder, Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EarliPointDevice

    EarliPoint is a non-invasive diagnostic device for ASD

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The EarliPoint Device repeatability

    EarliPoint Device repeatability agreement in producing binary diagnostic outcomes (clinically-positive or negative for ASD) between multiple measurements per subject conducted with the same device (i.e., intra-device agreement);classification of either clinically-positive or clinically-negative for autism spectrum disorder (ASD) as well as each of the three EarliPoint Device severity scores (the social disability index, verbal ability index, and nonverbal ability index).

    Measured: Anticipated in about 6 months

  2. The EarliPoint Device reproducibility

    EarliPoint Device reproducibility agreement in producing binary diagnostic outcomes (clinically-positive or negative for ASD) between single measurements per subject conducted with multiple devices (i.e., inter-device agreement);

    Measured: Anticipated in about 6 months

  3. The repeatability variance of the underlying EarliPoint Device

    Repeatability variance of the underlying EarliPoint Device ASD presence metric (this metric is a continuous score underlying the binary diagnostic outcome: values less than or equal to 0 indicate a patient has ASD [clinically-positive], values greater than 0 indicate a patient does not have ASD [clinically-negative]);

    Measured: Anticipated in about 6 months

  4. The reproducibility variance of the underlying EarliPoint Device

    reproducibility variance of the underlying EarliPoint Device ASD presence metric (this metric is a continuous score underlying the binary diagnostic outcome: values less than or equal to 0 indicate a patient is ASD positive, values greater than 0 indicate a patient is ASD negative).

    Measured: Anticipated in about 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Apr 2021
  2. Study start7 May 2021
  3. Primary completion17 Nov 2021
  4. Study completion17 Nov 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
45 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04860986
Sponsor's protocol ID
CLN-1001-001
Acronym
RnR
Status last verified
Nov 2023
First submitted
14 Apr 2021
Last updated
8 Nov 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: There is no plan to share individual participant data (IPD) to other researchers.

Publications

  • Jones W, Klaiman C, Richardson S, Lambha M, Reid M, Hamner T, Beacham C, Lewis P, Paredes J, Edwards L, Marrus N, Constantino JN, Shultz S, Klin A. Development and Replication of Objective Measurements of Social Visual Engagement to Aid in Early Diagnosis and Assessment of Autism. JAMA Netw Open. 2023 Sep 5;6(9):e2330145. doi: 10.1001/jamanetworkopen.2023.30145.

    PubMed 37669054

  • Jones W, Klaiman C, Richardson S, Aoki C, Smith C, Minjarez M, Bernier R, Pedapati E, Bishop S, Ence W, Wainer A, Moriuchi J, Tay SW, Klin A. Eye-Tracking-Based Measurement of Social Visual Engagement Compared With Expert Clinical Diagnosis of Autism. JAMA. 2023 Sep 5;330(9):854-865. doi: 10.1001/jama.2023.13295.

    PubMed 37668621

Questions about this trial

What is this clinical trial studying?

An observational study of Autism Spectrum Disorder (ASD), run by EarliTec Diagnostics, Inc 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 6 inclusion and 8 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: finished, as of the sponsor's last update on 8 Nov 2023. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

The EarliPoint Device repeatability (time frame: Anticipated in about 6 months). The study lists 4 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 NCT04860986, which also lists 2 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 8 Nov 2023.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in