Added Value of the Oculomotor and Cognitive Examination in the Management of Patients With Attention Deficit Disorder With or Without Hyperactivity. Interventional Study to Evaluate Current Care
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Change in saccade latency after acute and chronic 6-month administration of methylphenidate vs. baseline
研究概览
简要总结
ADHD is a neurodevelopmental disorder characterized by symptoms of inattention and / or hyperactivity-impulsivity that affects nearly 6% of school-aged children and persists into adulthood. More and more studies are interested in biomarkers of this pathology. The oculomotricity, which allows to highlight deficits motor and attention present in ADHD, is used routinely in the expert centers. In general, the pharmacological treatment of ADHD is associated with a clinical response in approximately 70% of cases. Today, there is no review to predict the individual response to treatment.
Hypotheses The investigators hypothesize that a precise analysis of the oculomotor markers will allow to measure the improvement of the symptomatology of the ADHD disorder following the introduction of the psycho-stimulatory treatment. In other words, the investigators hypothesize that these markers could be a useful aid in patient follow-up by the clinician and allow early identification of responder and non-responder patients.
Primary objective The main objective of this study is to measure the added value of oculomotor examination in the follow-up of psycho-stimulant-treated ADHD patients.
Main Evaluation Criteria The primary endpoint is oculomotor performance. Parameters analyzed for each saccade are latency, amplitude, duration, average speed, direction.
Secondary Criteria Evaluation (s) Correlations will be established between oculomotor data and scores obtained at the clinical scales assessing ADHD symptoms of inattention and hyperactivity as well as cognitive performance. The data obtained before the introduction of the psycho-stimulant treatment (V0, baseline) will be compared with those obtained after acute administration of methylphenidate (10 mg orally,V1) and during the follow-up visit at 6 months (V2).
详细描述
Type of study and experimental plan:
This is an interventional study designed to evaluate routine care. Number of Necessary Subjects Participants will be stratified by age to control the effect of age. The age groups to be analyzed are: 7-9 vs 10-12 vs. 13-18 versus 19-29 vs 30-40 and 41-50, each with at least 15 participants. total of 90 participants.
• Study population The patients included in this study are followed in the general psychiatric department of the Rouffach hospital center for attention deficit disorder with or without hyperactivity (ADHD). The study focuses on ADHD patients aged 7 to 50 years, undergoing an oculomotor and cognitive examination before the initiation of psychostimulant therapy with methylphenidate (MPH) (baseline, V0); two weeks later (V1) following a single low dose administration of MPH (10 mg orally given at 8 AM) ; and at 6-month follow-up (V2) when patients are medicated with adequate dose of MPH.
• Clinical assessments All subjects are evaluated directly by psychiatrists and neuropsychologists who are experts in the field of ADHD and are experienced in the use of standardized or semi-standardized clinical instruments. Clinical investigation allows extensive and standardized evaluation of patients.
- Categorical standardized assessment of ADHD symptoms Diagnostic and Statistical Manual (DSM-IV-TR) ADHD Criteria: Subtype: Combined, Inattentive, Hyperactive-Impulsive.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 7 Years 至 50 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ADHD diagnosis according to DSM-IV-TR criteria
- •Beneficiary of a social security scheme
- •Having undergone an oculomotor examination as part of their usual care
- •Normal neurological examination
排除标准
- •Intellectual Disability (IQ < 70)
- •Proven neurological pathology or identified genetic syndrome
- •Vestibular pathology
- •Ear, nose, and throat (ENT) pathology
- •Neuro-ophthalmological pathology uncorrected by corrective glass (<10/10 in binocular vision
研究组 & 干预措施
ADHD patients
90 patients will be enrolled and assessed (i.e., neurocognitive and oculomotor tests) at baseline ; after a single low dose of methylphenidate (10 mg orally); and after 6 months of adequate dose of methylphenidate oral tablet
干预措施: Methylphenidate Oral Tablet (Drug)
结局指标
主要结局
Change in saccade latency after acute and chronic 6-month administration of methylphenidate vs. baseline
时间窗: Baseline (V0); methylphenidate test (V1; i.e., two weeks after V0, one hour after ingestion of a single low dose administration of MPH [10 mg orally given at 8 AM]); after 6 month's treatment with methylphenidate oral tablet (V2)
Latency (time between the onset of the target and the beginning of the eye movements in milliseconds)
Change in saccade average speed after acute and chronic 6-month administration of methylphenidate vs. baseline
时间窗: Baseline (V0); methylphenidate test (V1; i.e., two weeks after V0, one hour after ingestion of a single low dose administration of MPH [10 mg orally given at 8 AM]); after 6 month's treatment with methylphenidate oral tablet (V2)
Average speed of the saccade (degree per second)
Change in saccade accuracy after acute and chronic 6-month administration of methylphenidate vs. baseline
时间窗: Baseline (V0); methylphenidate test (V1; i.e., two weeks after V0, one hour after ingestion of a single low dose administration of MPH [10 mg orally given at 8 AM]); after 6 month's treatment with methylphenidate oral tablet (V2)
Saccade accuracy (characterized by the ratio of the amplitude of the first saccade to the amplitude of the target, expressed in percentage)
Change in direction errors after acute and chronic 6-month administration of methylphenidate vs. baseline
时间窗: Baseline (V0); methylphenidate test (V1; i.e., two weeks after V0, one hour after ingestion of a single low dose administration of MPH [10 mg orally given at 8 AM]); after 6 month's treatment with methylphenidate oral tablet (V2)
Direction errors (in percentage)
Change in express saccades after acute and chronic 6-month administration of methylphenidate vs. baseline
时间窗: Baseline (V0); methylphenidate test (V1; i.e., two weeks after V0, one hour after ingestion of a single low dose administration of MPH [10 mg orally given at 8 AM]); after 6 month's treatment with methylphenidate oral tablet (V2)
Express saccades (reaction time between 80 and 130 msec, expressed in percentage).
Change in anticipatory saccades after acute and chronic 6-month administration of methylphenidate vs. baseline
时间窗: Baseline (V0); methylphenidate test (V1; i.e., two weeks after V0, one hour after ingestion of a single low dose administration of MPH [10 mg orally given at 8 AM]); after 6 month's treatment with methylphenidate oral tablet (V2)
Anticipatory saccades (saccade initiated \< 80 msec after target appearance, in percentage)
次要结局
- Associations between clinical outcome after 6 month's methylphenidate treatment and change in oculomotor performance (from V0 to V1, V0 to V2, and V1 to V2)(Baseline (V0); methylphenidate test (V1; i.e., two weeks after V0, one hour after ingestion of a single low dose administration of MPH [10 mg orally given at 8 AM]); after 6 month's treatment with methylphenidate oral tablet (V2))
- Associations between oculomotor data and neurocognitive test results(Baseline (V0); methylphenidate test (V1; i.e., two weeks after V0, one hour after ingestion of a single low dose administration of MPH [10 mg orally given at 8 AM]); after 6 month's treatment with methylphenidate oral tablet (V2))
研究者
Fabrice Duval
MD, Psychiatrist
Centre Hospitalier Rouffach