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Neurotrack Test Validation Protocol

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02608021
Recruitment Status : Completed
First Posted : November 18, 2015
Last Update Posted : December 20, 2019
Sponsor:
Collaborator:
Neurotrack Technologies, Inc.
Information provided by (Responsible Party):
NYU Langone Health

Brief Summary:
This protocol describes a study to validate Neurotrack's visual paired comparison task, aimed at early detection and monitoring of memory impairment. The investigators will determine whether the novel task developed by Neurotrack is associated with markers of brain pathology associated with very early Alzheimer's disease. The elderly subjects studied will be cognitively normal (CN) or have amnestic mild cognitive impairment (aMCI). For the current study, the primary brain pathology parameters will be derived from MRI scans. Data from this study will be correlated with data from a parallel study designed to validate a larger group of new cognitive tasks by correlating test performance with a broader array of biomarkers of Alzheimer's disease.

Condition or disease
Mild Cognitive Impairment

Detailed Description:

The Neurotrack test has the potential to dramatically alter the current methods used for detecting cognitive deficits. Patients and research subjects could be screened for medial temporal lobe (MTL) impairment using inexpensive, widely available, safe, and non-invasive technology.

Subjects will be elderly individuals who are participating in ongoing research at the NYU Alzheimer's Disease Center (ADC) and who have received the standard ADC clinical evaluation within the past year, including a medical-neurological evaluation, neuro-psychological assessment and structural neuroimaging (MRI). As part of the current study, all subjects will receive both the Neurotrack Visual Paired-Comparison (VPC) Task and MRI scans. The current protocol strictly for a research study and there will be no "standard care" provided. Participants will be asked to come in for two separate sessions. The first session will involve screening to confirm eligibility and administration of the cognitive testing procedures, while the second session will involve the MRI protocol.

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Study Type : Observational
Actual Enrollment : 81 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Neurotrack Test Validation Protocol
Actual Study Start Date : October 1, 2015
Actual Primary Completion Date : October 2018
Actual Study Completion Date : October 17, 2018

Resource links provided by the National Library of Medicine


Group/Cohort
Amnestic mild cognitive impairment
Cognitively normal



Primary Outcome Measures :
  1. Presence of eye fixation assessed by a point of gaze continually remaining within 1 degree of visual angle for a period of 100 milliseconds or more. [ Time Frame: 2 months ]
    Eye fixation is defined as a point of gaze continually remaining within 1 degree of visual angle for a period of 100 milliseconds or more. Investigators will analyze the fixations that occur within 2 designated areas of interest (AOIs): the area of the novel image and the area of the familiar image.

  2. Eye tracking data - Total looking time [ Time Frame: 2 months ]
    Total looking time (i.e. the total sum of the duration for all fixations)

  3. Eye tracking data - Total number of fixations [ Time Frame: 2 months ]
    Total number of fixations (i.e. the total number of fixations that met the ≥100 ms criterion)

  4. Eye tracking data - Percentage looking time [ Time Frame: 2 months ]
    Percentage looking time on novel image


Secondary Outcome Measures :
  1. Correlation of MRI data with VPC task score [ Time Frame: 2 months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   60 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Individuals will be recruited from among participants at the NYU Alzheimer's Disease Center ADC, at the affiliated Center for Brain Health (CBH), and from other ongoing NYU research studies of the Center for Cognitive Neurology (CCN) that are affiliated with the ADC and for which participants receive the standard ADC research diagnostic assessment (the ADC Clinical Evaluation).
Criteria

Inclusion Criteria:

  1. Clinical diagnosis based on recent (within 1 year) consensus meeting, cross-referenced with standard neuropsychological scores:

    • Cognitively Normal (CN) Subjects: based on MMSE scores, CDR, and GDS.
    • Amnestic Mild Cognitive Impairment (aMCI) Subjects: Diagnosis of aMCI, based on MMSE scores, CDR, and GDS.
  2. Normal or corrected-to-normal vision and hearing (able to see images on computer screen and hear auditory events delivered through the computer speaker).

Exclusion Criteria:

  1. Significant history of mental illness, drug or alcohol abuse; severe trauma preventing normal use of dominant hand (needed to move the mouse cursor); clinical depression (unless medically controlled); other neurologic conditions (i.e. stroke), or learning disability; ophthalmologic/visual problems that prevent viewing a computer screen at a normal distance (such as legal blindness, detached retinas, occlusive cataracts).
  2. Having pacemakers, aneurysm clips, cochlear implants, pulse oximeters, EKG leads, tattoos or other metal/foreign objects in body or face and therefore unable to receive MRI.
  3. Lack the capacity to give informed consent and lack of an authorized surrogate to provide consent if the prospective subject is found to lack adequate consent capacity.
  4. Pregnancy, breastfeeding or planning to have a baby.

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): NCT02608021


Locations
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United States, New York
NYU Langone Medical Center
New York, New York, United States, 10016
Sponsors and Collaborators
NYU Langone Health
Neurotrack Technologies, Inc.
Investigators
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Principal Investigator: Steven H Ferris NYU Langone Medical Center

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Responsible Party: NYU Langone Health
ClinicalTrials.gov Identifier: NCT02608021    
Other Study ID Numbers: 14-00586
First Posted: November 18, 2015    Key Record Dates
Last Update Posted: December 20, 2019
Last Verified: December 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by NYU Langone Health:
Alzheimer's Disease
MRI
Additional relevant MeSH terms:
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Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Mental Disorders