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

NCT03201887 | Unknown DMC

• 1 other identifier: Tasmc16ys0ctil
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Traumatic Brain Damage; Chronic Pain

Outcome Measures

Primary Outcomes (1)

• Eye Movements

  Eye tracking used to evaluate eye behavior.

  1 month

Study Arms (4)

Sub-optimal Traumatic Brain Injury

EXPERIMENTAL

Sub-optimal effort

Behavioral: Sub-optimal effort; Behavioral: optimal effort

Sub-optimal effort Chronic pain

EXPERIMENTAL

Sub-optimal effort

Behavioral: Sub-optimal effort; Behavioral: optimal effort

Traumatic Brain Injury

NO INTERVENTION

optimal effort

Chronic pain

NO INTERVENTION

optimal effort

Interventions

Sub-optimal effort BEHAVIORAL

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

Also known as: Simulation condition

Sub-optimal Traumatic Brain Injury; Sub-optimal effort Chronic pain

optimal effort BEHAVIORAL

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

Also known as: control condition

Sub-optimal Traumatic Brain Injury; Sub-optimal effort Chronic pain

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).
• 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.

Sponsors & Collaborators

• Loewenstein Hospital: lead
• Ariel University: collaborator

MeSH Terms

Conditions

Brain Injuries, Traumatic; Chronic Pain

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Moti Ratmansky, MD

  Loewenstein Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Moti Ratmansky, MD

CONTACT

972-9-7709140; MottiR@clalit.org.il

Yoram Braw, PHD

CONTACT

972-54-8132604; yoramb@ariel.ac.il

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 17, 2017
• First Posted: June 28, 2017
• Study Start: July 1, 2017
• Primary Completion: January 1, 2019
• Study Completion: January 1, 2019
• Last Updated: June 28, 2017

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will not share