A Prospective Comparative Study to Evaluate a Novel Algorithm Using Data Derived from a Non-Invasive Digital Biomarker As a Diagnostic Aid for ADHD in Youth Ages 6-17.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Overall Agreement Rate (OAR) - probability that the test will be normal and the condition is normal or positive and the condition is positive, out of all subjects.
研究概览
简要总结
This study aims to demonstrate the accuracy of the MT1 algorithm using the MindTension biometric sensor device as a diagnostic aid for healthcare providers in diagnosing ADHD in youth ages ≥ 6 to ≤17 years.
详细描述
The study aims to demonstrate the accuracy of the MT1 algorithm. The output of the MT1 algorithm will be compared to a Gold Standard clinical diagnosis made by specialist clinician diagnosis supported by the Kiddie SADS Present and Lifetime semi-structured interview (K-SADS-PL) and norm-referenced measures of current ADHD symptom frequency and severity using the ADHD-RS-5 rating scale. Diagnosis will be scaled according to the Diagnostic and Statistical Manual of Mental Disorders- 5 (DSM-5) criteria, and made with agreement between two licensed specialists in ADHD (a Clinical Psychologist and a Psychiatrist).
Further to the above, demonstrate that the agreement between the MT1 output and the specialist clinician diagnosis will be non-inferior to the level of agreement between the clinician diagnosis with the Test of Visual Attention (TOVA) FDA cleared device.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Parent provision of signed and dated informed consent form
- •Child stated willingness to comply with all study procedures and availability for the duration of the study
- •Any gender, aged 6 to 17 years
- •Stimulant naïve or willing to wash out of stimulant for 3 days (approximately 72 hours) prior to testing with biometric and performance devices (MindTension + TOVA)
- •ADHD Group: Diagnosed with symptoms consistent with ADHD as determined by Mini Kid + an ADHD-RS score of 1.5SD above mean for age and sex
- •Control group: No diagnosable disorder on the Mini kid, and an ADHD-RS score within 1SD of the mean for age and sex.
排除标准
- •Current use of psychotropic medications that cannot be washed out in 3 days (approximately 72 hours)
- •Known current seizure disorder (history of febrile seizure allowed).
- •Presence of specific devices (e.g., cardiac pacemaker) that may interfere with the MindTension monitor
- •IQ<70 by clinician judgment
- •Meeting FULL criteria for current PTSD, GAD, MDD, or any lifetime diagnosis of ASD, Bipolar disorder, or psychotic disorder that was, in the opinion of the investigator, correctly obtained. May have symptoms of anxiety or dysthymia/depression not meeting criteria for a full disorder, or disorders such as simple phobia
- •Deaf or hearing impaired, since this will make it difficult to hear and respond to the auditory stimuli.
- •Inability to complete the assessments.
- •Any other concerns in the judgment of the PI.
结局指标
主要结局
Overall Agreement Rate (OAR) - probability that the test will be normal and the condition is normal or positive and the condition is positive, out of all subjects.
时间窗: From the beginning of clinical assessment until the end of testing (approximately 1-2 days).
The outcome measure will be calculated by using the following formula: Over All Agreement = (True Positive + True Negative) / (True Positive + True Negative + False Positive + False Negative) X 100.
次要结局
- Positive Predicted Value (PPV) - conditional probability that the condition will be positive if the test is positive.(From the beginning of clinical assessment until the end of testing (approximately 1-2 days).)
- Negative Predicted Value (NPV) - conditional probability that the condition will be normal if the test is normal.(From the beginning of clinical assessment until the end of testing (approximately 1-2 days).)
- Sensitivity - conditional probability that the test will be positive if the condition is positive.(From the beginning of clinical assessment until the end of testing (approximately 1-2 days).)
- Specificity - conditional probability that the test will be normal if the condition is normal.(From the beginning of clinical assessment until the end of testing (approximately 1-2 days).)