A Repeatability and Reproducibility Study of the EarliPoint™ Device

NCT04860986 | Completed

• 1 other identifier: CLN-1001-001
• Study Type: observational
• Target: 45
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Autism Spectrum Disorder (ASD)

Keywords

EarliPoint; Pediatric; Diagnosis

Outcome Measures

Primary Outcomes (4)

• 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).

  Anticipated in about 6 months

• 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);

  Anticipated in about 6 months

• 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 \[clinically-negative\]);

  Anticipated in about 6 months

• 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).

  Anticipated in about 6 months

Interventions

EarliPoint DEVICE

EarliPoint is a non-invasive diagnostic device for ASD

Eligibility Criteria

• Age: 16 Months - 30 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• EarliTec Diagnostics, Inc: lead

Study Sites (1)

Emory University

Atlanta, Georgia, 30329, United States

Location

Related Publications (2)

• 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.

  PMID: 37669054 BACKGROUND

• 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.

  PMID: 37668621 BACKGROUND

Related Links

• EarliPoint Evaluation for Autism Spectrum Disorder

MeSH Terms

Conditions

Autism Spectrum Disorder; Disease

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Sew-Wah Tay

  EarliTec Diagnostics, Inc

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2021
• First Posted: April 27, 2021
• Study Start: May 7, 2021
• Primary Completion: November 17, 2021
• Study Completion: November 17, 2021
• Last Updated: November 8, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)