Traumatic Brain DamageNCT03201887
Detecting Malingering Detection Using Eye Movements and Response Time (MDER)
A study testing Sub-optimal effort and optimal effort in people with Traumatic Brain Damage and Chronic Pain, run by Loewenstein Hospital.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Traumatic Brain Damage, Chronic Pain
- What is being tested?
- Sub-optimal effort and optimal effort
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2017to 1 Jan 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
Read the detailed description
Same as in the brief summary
- Conditions
- Traumatic Brain Damage, Chronic Pain
- Being tested
- Sub-optimal effort, optimal effort
- Medical subject headings
- Brain Injuries, Traumatic, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sub-optimal effortBehavioural
Also called Simulation condition
Participants will be asked to play a patient who wishes to present himself as having cognitive deficits or exaggerate existing cognitive deficits
optimal effortBehavioural
Also called control condition
Participants will be asked to perform tasks to the best of their abilities.
| Study group | Role | What they receive |
|---|---|---|
| Sub-optimal Traumatic Brain Injury | Experimental | Sub-optimal effort Receives: Behavioral: Sub-optimal effort; Behavioral: optimal effort |
| Sub-optimal effort Chronic pain | Experimental | Sub-optimal effort Receives: Behavioral: Sub-optimal effort; Behavioral: optimal effort |
| Traumatic Brain Injury | No intervention | optimal effort |
| Chronic pain | No intervention | optimal effort |
What is being measured
The primary outcome is the main question the study is designed to answer.
Eye Movements
Eye tracking used to evaluate eye behavior.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2017
- Study start1 Jul 2017 (estimated)
- Primary completion1 Jan 2019 (estimated)
- Study completion1 Jan 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Brain DamageStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Loewenstein Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Ariel University
- Responsible party
- Sponsor
- Investigators
- Moti Ratmansky, MD, Principal investigator, Loewenstein Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03201887
- Sponsor's protocol ID
- Tasmc16ys0ctil
- Status last verified
- Jan 2017
- First submitted
- 17 Jan 2017
- Last updated
- 28 Jun 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We do not plan to share IPD
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detecting Malingering Detection Using Eye Movements and Response Time
- ClinicalTrials.gov ID
- NCT03201887
- Acronym / sponsor ID
- Tasmc16ys0ctil
- Conditions
- Traumatic Brain Damage, Chronic Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Loewenstein HospitalUniversity, hospital or other
- Collaborators
- Ariel University
- Study start
- 1 Jul 2017 (estimated)
- Primary completion
- 1 Jan 2019 (estimated)
- Study completion
- 1 Jan 2019 (estimated)
- First posted
- 28 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Sub-optimal Traumatic Brain Injury | Experimental | Behavioral: Sub-optimal effort, Behavioral: optimal effortSub-optimal effort |
| Sub-optimal effort Chronic pain | Experimental | Behavioral: Sub-optimal effort, Behavioral: optimal effortSub-optimal effort |
| Traumatic Brain Injury | No intervention | –optimal effort |
| Chronic pain | No intervention | –optimal effort |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (9 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sub-optimal effortAlso: Simulation conditionParticipants will be asked to play a patient who wishes to present himself as having cognitive deficits or exaggerate existing cognitive deficits | Behavioural | Sub-optimal Traumatic Brain Injury, Sub-optimal effort Chronic pain |
| optimal effortAlso: control conditionParticipants will be asked to perform tasks to the best of their abilities. | Behavioural | Sub-optimal Traumatic Brain Injury, Sub-optimal effort Chronic pain |
Primary outcome
Eye Movements
Time frame: 1 month
Eye tracking used to evaluate eye behavior.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2017.
- Individual participant dataSharing planned: No. We do not plan to share IPD
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Moti Ratmansky, MD principal investigator
Loewenstein Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Sub-optimal effort and optimal effort in people with Traumatic Brain Damage and Chronic Pain, run by Loewenstein Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Moti Ratmansky, MD (972-9-7709140, MottiR@clalit.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Eye Movements (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2017; AzTrials last refreshed its copy on 28 Oct 2026.