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临床试验/NCT03201887
NCT03201887Unknown不适用

Detecting Malingering Detection Using Eye Movements and Response Time

Loewenstein Hospital0 个研究点目标入组 120 人开始时间: 2017年7月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
120
主要终点
Eye Movements

研究概览

简要总结

Performance Validity Tests (PVTs) are widely used for the detection of sub-optimal effort and malingering in neuropsychological assessments. Threats to their validity however likely to intensify with time (e.g., information available on the web or from legal representatives) and may lead to a decline in their ability to differentiate between malingerers and non-malingerers. Eye movements and response time (RT) are less obvious outcome measures and under less conscious control than more conventional PVT indices (e.g., accuracy). They are therefore promising measures that can aid in detecting malingering when used in conjunction with more conventional PVT indices. The Word Memory Test (WMT) is a widely used PVT in neuropsychological evaluations. As part of the proposed study, TBI patients, chronic pain patients and healthy adults (60 in each group) will be randomly divided to one of two conditions; optimal effort or sub-optimal effort (participants will be asked to play a TBI patient who wishes to present himself as having cognitive deficits or exaggerate existing cognitive deficits). The proposed study will improve the WMT's efficacy in detection of sub-optimal effort in neuropsychological evaluations and therefore protect its validity from future threats. In addition, the proposed study will provide us with better understanding of the effect of TBI on eye movements and RTs in general.

详细描述

Same as in the brief summary

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Basic Science
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • for all participants:
  • Adult (18-65) female and males.
  • Signed informed consent form.
  • Inclusion criteria for TBI group:
  • TBI of at least mild severity, as operationalized by Post traumatic amnesia (PTA) < 24 hours
  • Glasgow coma scale (GCS) of 13-15
  • Loss of consciousness (LOC) of 30 minutes or less.
  • Inclusion criteria for chronic pain patients:
  • Pain without apparent biological value that has persisted beyond three months. This will be based on the participant self-report, electronic medical records and consultation with treating physician.

排除标准

  • - Exclusion criteria for all participants:
  • Any current eye impairment (e.g., limited visual field, nystagmus, astigmatism [cylinder], strabismus or any other impairment specified by the participant), past strabismus, and refractive surgery.
  • Significant past neurological disorder/s and/or neurosurgery (special emphasis will be put on any language impairment such as aphasia).
  • Significant developmental disorders (e.g., learning disabilities such as dyslexia). (d)
  • Significant past or present psychiatric disorders (as evident, for example, in psychiatric inpatient hospitalization and past suicide attempts).
  • Exclusion according to the last three articles (a-c) will be decided by a joint consultation of the research team.
  • Exclusion criteria for TBI patients and healthy adults:
  • Any condition of chronic pain (see criteria in the inclusion for the chronic pain group).
  • Exclusion criteria for chronic pain patients and health adults:
  • Significant current neurological disorder/s (special emphasis will be put on any language impairment such as aphasia) as decided by a joint consultation of the research team.

结局指标

主要结局

Eye Movements

时间窗: 1 month

Eye tracking used to evaluate eye behavior.

次要结局

未报告次要终点

研究者

发起方
Loewenstein Hospital
申办方类型
Other
责任方
Sponsor

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