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Online Evaluation of the Diagnostic Accuracy of BlinkLab's Digital Assessments for Autism

2026年5月11日 更新者：Blinklab Limited

This observational study aims to evaluate how patterns of behavioral and sensorimotor responses measured using the BlinkLab Dx1 smartphone application relate to autism diagnoses in children ages 2 to 11. BlinkLab Dx1 is a non-invasive, smartphone-based application under development as a diagnostic aid for healthcare providers assessing autism.

In this study, children who have undergone a neurodevelopmental assessment within the past 12 months will complete two short, video-based sessions using the BlinkLab Dx1 app. The app presents visual and auditory stimuli and records reflexive sensorimotor responses and patterns of repetitive behavior. Additionally, primary caregivers will answer a short questionnaire in the app about symptoms and development. Information about prior neurodevelopmental assessments, including documented DSM-5-based diagnoses from routine clinical practice, will be collected retrospectively.

The study will examine how the app's neurobehavioral measurements relate to previously assigned clinical diagnoses. These paired data will be used to develop and evaluate a machine learning-based algorithm using separate training and testing datasets to assess whether patterns measured by BlinkLab Dx1 can help distinguish children with autism from children without an autism diagnosis.

This study does not involve any treatment or medical intervention.

調査の概要

状態

募集

条件

介入・治療

詳細な説明

Specification of the Time Perspective section in the Study Design: this study has a hybrid time perspective, as BlinkLab Dx1 measures are collected prospectively during remote sessions, while the clinical reference standard (presence of in a DSM-5-based diagnostic report from a neurodevelopmental assessment within the prior 12 months) is collected retrospectively. The clinical reference standard is based on neurodevelopmental assessments conducted in routine clinical care and is collected without influence from study procedures.

The study will use paired BlinkLab Dx1 measurements and clinical reference standard diagnoses to develop and evaluate a machine learning-based classification algorithm. The dataset will be divided into separate training and testing subsets, with the training dataset used to develop the model and determine classification thresholds, and the independent testing dataset used to evaluate diagnostic performance. The model will generate a classification categorizing participants as "Positive for autism", "Intermediate" or "Negative for autims". Participants with intermediate results are considered to have indeterminate findings and are excluded from primary diagnostic performance analyses, which are based on participants with definitive positive or negative test results.

研究の種類

観察的

入学 (推定)

1000

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

  • 名前：Myrthe J. Ottenhoff, MD, PhD
  • 電話番号：908-824-3471
  • メール：study@blinklab.org

研究場所

  • アメリカ
    • New Jersey
      • Princeton、New Jersey、アメリカ、08540
        • 募集
        • Remote study conducted nationwide; all participation occurs via smartphone app at home.
        • コンタクト：

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 子

健康ボランティアの受け入れ

はい

サンプリング方法

非確率サンプル

調査対象母集団

Children aged 2-11 years of which the parents/caregivers and/or pediatrician (or other primary care provider) have raised concerns regarding their neurodevelopment and have undergone neurodevelopmental assessment in the last 12 months that would allow diagnosing any neurodevelopmental condition according to DSM5 criteria.

説明

Inclusion Criteria:

  1. Age: Children between 2 to 11 years old
  2. Parent/Caregiver/Healthcare Provider Concern: The child has received a diagnostic outcome of a neurodevelopmental assessment based on DSM-5 criteria within the past 12 months.
  3. Language Proficiency: Parents and subjects must have functional English capability in the home environment.
  4. Informed Consent: Parents must be able to read, understand, and voluntarily sign the Informed Consent Form (ICF).
  5. Videotaping: subjects must be willing to be videotaped during the diagnostic assessment by the BlinkLab App.

Exclusion Criteria:

  1. Device Compatibility: Parents without smartphone capabilities necessary for using the BlinkLab app.
  2. Previous Enrollment: Subjects who have been previously enrolled in any BlinkLab clinical study.
  3. Location of at home testing: Not being able to complete all remote at-home study sessions within the US.
  4. History of audiogenic seizures: Participants with a known history of seizures that are triggered by auditory stimuli, including reflex or startle epilepsy provoked by sounds (audiogenic seizures), or any other form of sound-induced epilepsy.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

コホートと介入

グループ/コホート
介入・治療
Model Development Group - Children evaluated for neurodevelopmental conditions.
Children aged 2-11 who have formally been evaluated for neurodevelopmental conditions in the 12 months prior to the enrollment date. This includes children with and without autism, children with other neurodevelopmental conditions and children eventually not diagnosed with any neurodevelopmental condition.
診断テスト：BlinkLab Dx1
BlinkLab Dx1 is a machine learning-based algorithm that generates a continuous score reflecting likelihood of autism from neurobehavioral responses (including measures such as pre-pulse inhibition and habituation, motor activity, and vocalizations) recorded during standardized video-watching sessions in a mobile application. Pre-specified thresholds, determined during model development and fixed prior to evaluation in the independent test dataset, are applied to categorize results as " Positive for autism", "Intermediate" or "Nagative for autism". Results in the intermediate category are considered indeterminate and are excluded from primary diagnostic performance analyses, which are based on participants with definitive positive or negative test results.
行動：Retrospective Neurodevelopmental Diagnostic Assessment
The clinical reference standard is a retrospective neurodevelopmental diagnostic assessment conducted within 12 months prior to enrollment, based on DSM-5 criteria. Participants are classified as having or not having an autism diagnosis based on the documented diagnostic conclusions of these assessments.
Model Testing Group - Children evaluated for neurodevelopmental conditions.
Children aged 2-11 who have formally been evaluated for neurodevelopmental conditions in the 12 months prior to the enrollment date. This includes children with and without autism, children with other neurodevelopmental conditions and children eventually not diagnosed with any neurodevelopmental condition. Data collection for this group is blinded.
診断テスト：BlinkLab Dx1
BlinkLab Dx1 is a machine learning-based algorithm that generates a continuous score reflecting likelihood of autism from neurobehavioral responses (including measures such as pre-pulse inhibition and habituation, motor activity, and vocalizations) recorded during standardized video-watching sessions in a mobile application. Pre-specified thresholds, determined during model development and fixed prior to evaluation in the independent test dataset, are applied to categorize results as " Positive for autism", "Intermediate" or "Nagative for autism". Results in the intermediate category are considered indeterminate and are excluded from primary diagnostic performance analyses, which are based on participants with definitive positive or negative test results.
行動：Retrospective Neurodevelopmental Diagnostic Assessment
The clinical reference standard is a retrospective neurodevelopmental diagnostic assessment conducted within 12 months prior to enrollment, based on DSM-5 criteria. Participants are classified as having or not having an autism diagnosis based on the documented diagnostic conclusions of these assessments.

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Sensitivity of BlinkLab Dx1
時間枠：Baseline (including index test completed during the enrollment period and reference standard diagnosis from assessments conducted within 12 months prior to enrollment)
Sensitivity of BlinkLab Dx1, defined as the proportion of participants with a positive clinical reference standard diagnosis of autism who are correctly identified as positive by the index test.
Baseline (including index test completed during the enrollment period and reference standard diagnosis from assessments conducted within 12 months prior to enrollment)
Specificity of BlinkLab Dx1
時間枠：Baseline (including index test completed during the enrollment period and reference standard diagnosis from assessments conducted within 12 months prior to enrollment)
Specificity of the BlinkLab Dx1 algorithm, defined as the proportion of participants without a clinical reference standard diagnosis of autism who are correctly identified as negative by the index test.
Baseline (including index test completed during the enrollment period and reference standard diagnosis from assessments conducted within 12 months prior to enrollment)

二次結果の測定

結果測定
メジャーの説明
時間枠
Adverse Events
時間枠：During individual enrollment period (up to 30 days)
A qualitative description of any adverse events that occurred during the study from the time of informed consent until the completion of the diagnostic evaluation.
During individual enrollment period (up to 30 days)
Usability
時間枠：During the individual enrollment period (up to 30 days)
The usability of the device for parents/caregivers in relation to the use-related risk analysis identified risks.
During the individual enrollment period (up to 30 days)
Autism Symptom Severity
時間枠：Baseline (including neurodevelopmental assessment data from up to 12 months prior to enrollment and a single SRS-2 assessment collected once during the enrollment period [up to 30 days after enrollment])
Based on prospectively collected SRS-2 questionnaire scores and retrospectively collected standardized autism assessment results documented in the neurodevelopmental assessment report.
Baseline (including neurodevelopmental assessment data from up to 12 months prior to enrollment and a single SRS-2 assessment collected once during the enrollment period [up to 30 days after enrollment])
Positive Predictive Value (PPV) of BlinkLab Dx1
時間枠：Baseline (including index test completed during the enrollment period and reference standard diagnosis from assessments conducted within 12 months prior to enrollment)
Positive predictive value, defined as the proportion of participants with a positive BlinkLab Dx1 test result who have a positive clinical reference standard diagnosis of autism.
Baseline (including index test completed during the enrollment period and reference standard diagnosis from assessments conducted within 12 months prior to enrollment)
Negative Predictive Value of BlinkLab Dx1
時間枠：Baseline (including index test completed during the enrollment period and reference standard diagnosis from assessments conducted within 12 months prior to enrollment)
Negative predictive value, defined as the proportion of participants with a negative BlinkLab Dx1 test result who do not have a clinical reference standard diagnosis of autism.
Baseline (including index test completed during the enrollment period and reference standard diagnosis from assessments conducted within 12 months prior to enrollment)
False Positive Rate of BlinkLab Dx1
時間枠：Baseline (including index test completed during the enrollment period and reference standard diagnosis from assessments conducted within 12 months prior to enrollment)
False positive rate, defined as the proportion of participants without a clinical reference standard diagnosis of autism who are incorrectly identified as positive by the BlinkLab Dx1 index test.
Baseline (including index test completed during the enrollment period and reference standard diagnosis from assessments conducted within 12 months prior to enrollment)
False Negative Rate of BlinkLab Dx1
時間枠：Baseline (including index test completed during the enrollment period and reference standard diagnosis from assessments conducted within 12 months prior to enrollment)
False negative rate, defined as the proportion of participants with a clinical reference standard diagnosis of autism who are incorrectly identified as negative by the BlinkLab Dx1 index test.
Baseline (including index test completed during the enrollment period and reference standard diagnosis from assessments conducted within 12 months prior to enrollment)
Accuracy of BlinkLab Dx1
時間枠：Baseline (including index test completed during the enrollment period and reference standard diagnosis from assessments conducted within 12 months prior to enrollment)
Accuracy, defined as the proportion of all participants who are correctly classified by the BlinkLab Dx1 index test (i.e., the sum of true positives and true negatives divided by the total number of participants), relative to the clinical reference standard diagnosis.
Baseline (including index test completed during the enrollment period and reference standard diagnosis from assessments conducted within 12 months prior to enrollment)

その他の成果指標

結果測定
メジャーの説明
時間枠
Timing Task Performance
時間枠：Single time point during enrollment period (up to 30 days after enrollment)
Performance on the BlinkLab timing task and its relation with ADHD symptom severity as measured with the modified Vanderbilt ADHD Diagnostic Parent Rating Scale (VADRS)
Single time point during enrollment period (up to 30 days after enrollment)
Go/No-Go Taks Performance
時間枠：Single time point during enrollment period (up to 30 days after enrollment)
Performance on the Blinklab go/no-go task and its relation with ADHD symptom severity as measured with the VADRS.
Single time point during enrollment period (up to 30 days after enrollment)
Latency Task Performance
時間枠：Single time point during enrollment period (up to 30 days after enrollment)
Performance on the Blinklab latency task and its relation with ADHD symptom severity as measured with the VADRS.
Single time point during enrollment period (up to 30 days after enrollment)

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Blinklab Limited

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2025年2月15日

一次修了 (推定)

2026年9月1日

研究の完了 (推定)

2026年12月1日

試験登録日

最初に提出

2026年5月11日

QC基準を満たした最初の提出物

2026年5月11日

最初の投稿 (実際)

2026年5月15日

学習記録の更新

投稿された最後の更新 (実際)

2026年5月15日

QC基準を満たした最後の更新が送信されました

2026年5月11日

最終確認日

2026年5月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • 08012025

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

未定

IPD プランの説明

BlinkLab is a publicly listed company holding patents related to the BlinkLab Dx technology. The sponsor intends to evaluate mechanisms for sharing de-identified, non-proprietary participant-level data with qualified academic investigators under data use agreements that protect participant privacy and BlinkLab's intellectual property. Any shared data will exclude raw video, audio, or algorithmic outputs that are proprietary or potentially identifiable.

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

はい

米国で製造され、米国から輸出された製品。

いいえ

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

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