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

Detecting Malingering Detection Using Eye Movements and Response Time

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.

Study Overview

• Status: Unknown
• Conditions: Chronic Pain; Traumatic Brain Damage
• Intervention / Treatment: Behavioral: Sub-optimal effort; Behavioral: optimal effort

Detailed Description

Same as in the brief summary

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Not Applicable

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion criteria 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.

Exclusion Criteria:

- 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sub-optimal Traumatic Brain Injury; Sub-optimal effort	Behavioral: 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; Other Names: Simulation condition; Behavioral: optimal effort; Participants will be asked to perform tasks to the best of their abilities.; Other Names: control condition
Experimental: Sub-optimal effort Chronic pain; Sub-optimal effort	Behavioral: 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; Other Names: Simulation condition; Behavioral: optimal effort; Participants will be asked to perform tasks to the best of their abilities.; Other Names: control condition
No Intervention: Traumatic Brain Injury; optimal effort
No Intervention: Chronic pain; optimal effort

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Eye Movements	Eye tracking used to evaluate eye behavior.	1 month

Collaborators and Investigators

• Sponsor: Loewenstein Hospital
• Collaborators: Ariel University
• Investigators: Principal Investigator: Moti Ratmansky, MD, Loewenstein Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): July 1, 2017
• Primary Completion (Anticipated): January 1, 2019
• Study Completion (Anticipated): January 1, 2019

Study Registration Dates

• First Submitted: January 17, 2017
• First Submitted That Met QC Criteria: June 26, 2017
• First Posted (Actual): June 28, 2017

Study Record Updates

• Last Update Posted (Actual): June 28, 2017
• Last Update Submitted That Met QC Criteria: June 26, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Wounds and Injuries; Craniocerebral Trauma; Trauma, Nervous System; Chronic Pain; Brain Injuries; Brain Injuries, Traumatic; Malingering
• Other Study ID Numbers: Tasmc16ys0ctil

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: We do not plan to share IPD

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No