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

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ClinicalTrials.gov Identifier: NCT03201887
Recruitment Status : Unknown
Verified January 2017 by Loewenstein Hospital.
Recruitment status was:  Not yet recruiting
First Posted : June 28, 2017
Last Update Posted : June 28, 2017
Sponsor:
Collaborator:
Ariel University
Information provided by (Responsible Party):
Loewenstein Hospital

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.

Condition or disease Intervention/treatment Phase
Traumatic Brain Damage Chronic Pain Behavioral: Sub-optimal effort Behavioral: optimal effort Not Applicable

Detailed Description:
Same as in the brief summary

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Official Title: Detecting Malingering Detection Using Eye Movements and Response Time
Estimated Study Start Date : July 1, 2017
Estimated Primary Completion Date : January 1, 2019
Estimated Study Completion Date : January 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chronic Pain

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 Name: Simulation condition

Behavioral: optimal effort
Participants will be asked to perform tasks to the best of their abilities.
Other Name: 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 Name: Simulation condition

Behavioral: optimal effort
Participants will be asked to perform tasks to the best of their abilities.
Other Name: control condition

No Intervention: Traumatic Brain Injury
optimal effort
No Intervention: Chronic pain
optimal effort



Primary Outcome Measures :
  1. Eye Movements [ Time Frame: 1 month ]
    Eye tracking used to evaluate eye behavior.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03201887


Contacts
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Contact: Moti Ratmansky, MD 972-9-7709140 MottiR@clalit.org.il
Contact: Yoram Braw, PHD 972-54-8132604 yoramb@ariel.ac.il

Sponsors and Collaborators
Loewenstein Hospital
Ariel University
Investigators
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Principal Investigator: Moti Ratmansky, MD Loewenstein Hospital

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Responsible Party: Loewenstein Hospital
ClinicalTrials.gov Identifier: NCT03201887     History of Changes
Other Study ID Numbers: Tasmc16ys0ctil
First Posted: June 28, 2017    Key Record Dates
Last Update Posted: June 28, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: We do not plan to share IPD

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Brain Injuries, Traumatic
Chronic Pain
Brain Injuries
Brain Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries
Malingering
Pain
Neurologic Manifestations
Signs and Symptoms
Central Nervous System Diseases
Nervous System Diseases
Behavioral Symptoms