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临床试验/NCT02522065
NCT02522065已完成不适用

Motor Response to Dopaminergic Therapy in a Population of de Novo Parkinson's Disease Cases Quantified Via Typing Analyses - -neuroQWERTY

Fundación de investigación HM6 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2015年5月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
60
试验地点
6
主要终点
Percentage of participants with a motor response to medication > 4 UPDRS-III points detected by the developed algorithm (sensitivity to a motor change).

研究概览

简要总结

The motor impairment produced by Parkinson's disease (PD) is a significant and debilitating part of the condition. Current methods to evaluate this impairment rely on subjective examinations. The investigators seek to develop an objective assessment of motor deficits by monitoring the participants natural interactions with a keyboard (on a computer or smart device). This approach provides a window to how the brain behaves during typical daily use of these devices, i.e. writing a report, sending an email or any other task performed on a digital device and thus has the potential to be used easily and regularly. (Importantly, the data gathered are non-sensitive and based only on timing information).

PD participants will be recruited during outpatient visits to PD clinics throughout the Madrid metropolitan region. General entry criteria will be those patients who are scheduled to begin dopaminergic therapy, and own a home computer or laptop. The study will not impact on participants' standard clinical management other than by asking the participants to type for 15 minutes at each of the clinic visits, and installing the investigators proprietary software on their home computer. This software will collect keystroke data alone. (None of the actual information about what is being typed will be collected.) The keystroke data collected will be analyzed and compared with standard clinical metrics of therapeutic response, as well as the in-clinic typing data.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Participants between 18 years and 70 years (older subjects will be deemed eligible on an individual basis after review by the study team).
  • Parkinson's disease (PD) diagnosis according to the United Kingdom Brain Bank Criteria.
  • PD patients without cognitive or psychiatric disturbances, as measured by the baseline assessment.
  • Prescription of symptomatic therapy with L-Dopa or dopamine agonists based on functional impairment attributed to PD. This will be based on the participant's physician criteria based on:
  • Involvement of the dominant hand and/or upper limbs.
  • Employed patients which the disease impairs their ability to work.
  • Daily computer use > 30 minutes

排除标准

  • Mild cognitive impairment or dementia.
  • Psychiatric symptoms
  • Expected or current use of sedative medication (benzodiazepines, opiates, antihistaminergic drugs).
  • Neuroleptic use.
  • History of parkinsonism for the controls.
  • Severe osteo-articular problems with upper limb functional limitation (amputations, severe osteo-arthritis).
  • Alcohol risk use (>40 gr/day or 4 standard drinks for male / >24gr/day or 2 standard drinks for female).
  • Narcolepsy or other sleep disorder producing hypersomnia (obstructive apnea, acute confusional states).
  • Any other life- threatening condition (advanced cancer, severe hepatic or renal insufficiencies.

结局指标

主要结局

Percentage of participants with a motor response to medication > 4 UPDRS-III points detected by the developed algorithm (sensitivity to a motor change).

时间窗: 24-weeks

A diagnostic table will be computed with all the study subjects. Those subjects with a clinical relevant response to medication (\> 4 points in UPDRS - III) will be considered as true positives. Then, the accuracy of the typing test to detect them will be evaluated. For this purpose, the sensitivity, specificity, predictive values and ROC curve of a classification algorithm based on our nQ index will be computed. This will allow us assessing the validity of the test to identify a motor change. detected by the developed algorithm (sensitivity to a motor change).

次要结局

  • Agreement between nQ and UPDRS motor subscale(4,8,16,24-weeks)
  • Comparison between nQ and the different motor tests (Purdue Pegboard test score & Alternating Finger Tapping)(4,8,16,24-weeks)
  • Comparison between nQ and the CISI-PD, PDQ-39 and NMSS scales(4,8,16,24-weeks)
  • Effect of dopaminergic medication measured by nQ(4,8,16,24-weeks)
  • Stability of the nQ index in a less controlled environment ("home-setting").(Week 1)

研究者

发起方
Fundación de investigación HM
申办方类型
Other
责任方
Sponsor

研究点 (6)

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