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临床试验/NCT04504890
NCT04504890Unknown不适用

Ocular-vestibular Biomarker Identification for ADHD

Sync-Think, Inc.1 个研究点 分布在 1 个国家目标入组 240 人开始时间: 2020年7月16日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
240
试验地点
1
主要终点
Eye Tracking ADHD Diagnostic ROC

研究概览

简要总结

This study intends to establish a relationship between oculovestibular eye tracking measures, measures of ADHD, and medication prescribed for ADHD.

详细描述

This study will use a predictive visual tracking paradigm (SyncThink EYE-SYNC eye tracking paradigm) to dynamically capture the participants' attentional state. It will examine the validity of the eye tracking paradigm in identifying the disruption in attentional networks caused by ADHD by examining the association between eye tracking performances and well-established standardized measures of ADHD.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
6 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Men and women ages 6-70 seeking evaluation and treatment for ADHD.

排除标准

  • Clinical diagnosis of a neurological condition including the following: stroke, multiple sclerosis, epilepsy, brain tumor/cancer, dyslexia, nystagmus and/or other major neurological condition.
  • Clinical diagnosis of any of the following eye-sight abnormalities: uncorrected amblyopia, uncorrected myopia, uncorrected presbyopia, uncorrected farsightedness or uncorrected Astigmatism.
  • Psychiatric history with any of the following:
  • LIFETIME: Clinical diagnosis of a psychotic disorder; bipolar disorder
  • LAST YEAR: Clinical diagnosis of major depressive disorder; PTSD; clinical diagnosis of substance abuse disorder; major anxiety disorder
  • Use of a psychotropic medication
  • Impairment of cranial nerves II-VI
  • Participants who receive a 'Poor' or 'Fair' eye tracking quality result on either their baseline or follow-up evaluations will be excluded from analysis. Subjects may not repeat participation

结局指标

主要结局

Eye Tracking ADHD Diagnostic ROC

时间窗: through study completion, an average of 1 year

Specific eye tracking parameters will be compared to determine which have the greatest diagnostic utility. Supervised machine learning models will be generated and optimized ROC AUC for both children and adults using eye tracking parameters as input and CAARS indices, CBRS indices, and clinical diagnosis as outcomes

Eye Tracking and ADHD measure correlation

时间窗: through study completion, an average of 1 year

Zero-order correlations among eye tracking parameters, CAARS ADHD indices, CBRS ADHD indices, and confounding variables

MANCOVA Eye Tracking in ADHD Treatment Population

时间窗: through study completion, an average of 1 year

Repeated measures multivariate analysis of covariance (MANCOVA) will be used to compare eye tracking performance over time in adults and children with ADHD (medicated and unmedicated)

次要结局

未报告次要终点

研究者

发起方
Sync-Think, Inc.
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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