Detecting Malingering Detection Using Eye Movements and Response Time (MDER)

NCT ID: NCT03201887

Last Updated: 2017-06-28

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-07-01
• Study Completion Date: 2019-01-01

Brief Summary

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.

Detailed Description

Same as in the brief summary

Conditions

Traumatic Brain Damage; Chronic Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

Sub-optimal Traumatic Brain Injury

Sub-optimal effort

Group Type: EXPERIMENTAL

Sub-optimal effort

Intervention Type: BEHAVIORAL

Participants will be asked to play a patient who wishes to present himself as having cognitive deficits or exaggerate existing cognitive deficits

optimal effort

Intervention Type: BEHAVIORAL

Participants will be asked to perform tasks to the best of their abilities.

Sub-optimal effort Chronic pain

Sub-optimal effort

Group Type: EXPERIMENTAL

Sub-optimal effort

Intervention Type: BEHAVIORAL

Participants will be asked to play a patient who wishes to present himself as having cognitive deficits or exaggerate existing cognitive deficits

optimal effort

Intervention Type: BEHAVIORAL

Participants will be asked to perform tasks to the best of their abilities.

Traumatic Brain Injury

optimal effort

Group Type: NO_INTERVENTION

No interventions assigned to this group

Chronic pain

optimal effort

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Sub-optimal effort

Participants will be asked to play a patient who wishes to present himself as having cognitive deficits or exaggerate existing cognitive deficits

Intervention Type: BEHAVIORAL

optimal effort

Participants will be asked to perform tasks to the best of their abilities.

Intervention Type: BEHAVIORAL

Other Intervention Names

Simulation condition; control condition

Eligibility Criteria

Inclusion Criteria

• Adult (18-65) female and males.
• Signed informed consent form.

• 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.

• 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.

Exclusion Criteria

• 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.
• Any condition of chronic pain (see criteria in the inclusion for the chronic pain group).
• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ariel University

OTHER

Sponsor Role: collaborator

Loewenstein Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Moti Ratmansky, MD

Role: PRINCIPAL_INVESTIGATOR

Loewenstein Hospital

Central Contacts

Moti Ratmansky, MD

Role: CONTACT

MottiR@clalit.org.il

972-9-7709140

Yoram Braw, PHD

Role: CONTACT

yoramb@ariel.ac.il

972-54-8132604

Other Identifiers

Tasmc16ys0ctil

Identifier Type: -

Identifier Source: org_study_id