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

Primary Purpose

Traumatic Brain Damage, Chronic Pain

Status

Unknown status

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Sub-optimal effort

optimal effort

About this trial

This is an interventional basic science trial for Traumatic Brain Damage

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

No Intervention

Arm Label

Sub-optimal Traumatic Brain Injury

Sub-optimal effort Chronic pain

Traumatic Brain Injury

Chronic pain

Arm Description

Sub-optimal effort

optimal effort

Outcomes

Primary Outcome Measures

Eye Movements

Eye tracking used to evaluate eye behavior.

Secondary Outcome Measures

Full Information

NCT ID

NCT03201887

First Posted

January 17, 2017

Last Updated

June 26, 2017

Sponsor

Loewenstein Hospital

Collaborators

Ariel University

1. Study Identification

Unique Protocol Identification Number

NCT03201887

Brief Title

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

Official Title

Detecting Malingering Detection Using Eye Movements and Response Time

Study Type

Interventional

2. Study Status

Record Verification Date

January 2017

Overall Recruitment Status

Unknown status

Study Start Date

July 1, 2017 (Anticipated)

Primary Completion Date

January 1, 2019 (Anticipated)

Study Completion Date

January 1, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Loewenstein Hospital

Collaborators

Ariel University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Traumatic Brain Damage, Chronic Pain

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

Participant

Allocation

Randomized

Enrollment

120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Sub-optimal Traumatic Brain Injury

Arm Type

Experimental

Arm Description

Sub-optimal effort

Arm Title

Sub-optimal effort Chronic pain

Arm Type

Experimental

Arm Description

Sub-optimal effort

Arm Title

Traumatic Brain Injury

Arm Type

No Intervention

Arm Description

optimal effort

Arm Title

Chronic pain

Arm Type

No Intervention

Arm Description

optimal effort

Intervention Type

Behavioral

Intervention Name(s)

Sub-optimal effort

Other Intervention Name(s)

Simulation condition

Intervention Description

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

Intervention Name(s)

optimal effort

Other Intervention Name(s)

control condition

Intervention Description

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

Primary Outcome Measure Information:

Title

Eye Movements

Description

Eye tracking used to evaluate eye behavior.

Time Frame

1 month

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Moti Ratmansky, MD

Phone

972-9-7709140

MottiR@clalit.org.il

First Name & Middle Initial & Last Name or Official Title & Degree

Yoram Braw, PHD

Phone

972-54-8132604

yoramb@ariel.ac.il

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Moti Ratmansky, MD

Organizational Affiliation

Loewenstein Hospital

Official's Role

Principal Investigator

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

We do not plan to share IPD

Learn more about this trial

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

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