Eye Movement Recording as an Early Differential Diagnostic Tool for Alzheimer/Depression (MOMAD)

July 27, 2017 updated by: Centre Hospitalier Universitaire de Besancon

Early Oculomotor Markers in Alzheimer's Disease: Test of Predictive Value in the Differential Diagnosis Depression/Alzheimer

The global aim of our study is to validate eye movement recording as an early differential diagnostic tool, in order to discriminate as early as possible between neurodegenerative dementias of Alzheimer type and depressive pseudodementias (DPD). The investigators want to put forward idiosyncratic oculomotor characteristics of Alzheimer's disease (AD) and DPD respectively. Eye movements are sensitive markers of neurological diseases and can be used in a variety of clinical neurological syndromes.

This study compares 3 groups of 98 patients: patients suffering of AD and DPD and healthy persons. The patients AD will be recruited in the Memory Centre of Resources and Research of Besançon and patients DPD will be selected in the psychiatric department of the University Hospital of Besançon. The control participants will be recruited from the entourage of researchers and patients. The selection of participants in the 3 different groups is based on clinical examinations in psychiatry and neurology and neuropsychological assessments. After giving informed consent, patients will be evaluated by a psychiatrist and a neuropsychologist. The complete assessment takes 150 minutes.

After having set up patients, eye movements will be recorded using video-oculography techniques. The following tasks are performed: the basic dynamic eye movements (latency, hypometric and hypermetric saccades, reaction time, saccade speed, accuracy, pupil diameter) will be evaluated by the pro-saccade, anti-saccade and predictive saccade tasks. The emotional connotation tasks will be assessed by scan of images pair with emotional connotation and portrait analysis. The assessment takes 30 minutes.

This study will include 3 groups:

  • an Alzheimer group;
  • a depressed group;
  • a control group with healthy persons. The population of this study will be comprised of patients over age 60 with a visual acuity over 9/10, not diagnosed with eye disease and not neuropsychological sequelae that could disrupt the functioning oculomotor.

These people will be recruited on a voluntary basis, after notification and consent in the research center, the Psychiatry Clinical Department of the University Hospital of Besançon. This study was conducted over a period of 36 months.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

288

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Besançon, France, 25000
        • Recruiting
        • Univserity Hospital of Besançon - Psychiatry Department
        • Contact:
        • Contact:
        • Principal Investigator:
          • Pierre VANDEL, PUPH

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • subject whose visual acuity > 9/10
  • subject without a diagnosis of eye disease
  • subject without a neuropsychological sequelae
  • for depressed patients :subject with a diagnosis of depression confirmed by a psychiatric evaluation and MADRS (Montgomery and Asberg Depression Rating Scale) score >25 and without cognitive impairment or any other psychiatric pathology and MMSE (Mini Mental State Examination)≥18 and without symptoms of AD
  • for Alzheimer patients :subject with AD diagnosed according to NINCDS-ADRDA (National Institute of Neurological and Communicative Disorders and Stroke -Alzheimer's Disease and Related Disorders Association) criteria and MMSE ≥18 and without psychiatric disorder and MADRS score < 25
  • for control patients : subject without AD, depression or any other psychiatric condition identified by the diagnostic criteria or cognitive disorders and MADRS score <25 and MMSE > 20

Exclusion Criteria:

  • subject age under 60

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Alzheimer
Patients suffering of Alzheimer disease
Other: Eye movements will be recorded using video-oculography techniques based on both the corneal reflection principle and an infra-red light beam
. The system named H6-HSCN by Applied Science Laboratories (ASL®) helps keep the patient's head fixed on a support, important for the elderly population. This system allows to capture data with good temporal resolution (sampling at 360Hz) and good spatial resolution (accuracy of 0.1° of visual angle) at a distance of about 70 cm from the screen test with a visual angle of 32.6°. Results will be processed with ASL Result Software.
EXPERIMENTAL: Depression
Patients suffering from depression
Other: Eye movements will be recorded using video-oculography techniques based on both the corneal reflection principle and an infra-red light beam
. The system named H6-HSCN by Applied Science Laboratories (ASL®) helps keep the patient's head fixed on a support, important for the elderly population. This system allows to capture data with good temporal resolution (sampling at 360Hz) and good spatial resolution (accuracy of 0.1° of visual angle) at a distance of about 70 cm from the screen test with a visual angle of 32.6°. Results will be processed with ASL Result Software.
EXPERIMENTAL: Healthy
Healthy volunteers
Other: Eye movements will be recorded using video-oculography techniques based on both the corneal reflection principle and an infra-red light beam
. The system named H6-HSCN by Applied Science Laboratories (ASL®) helps keep the patient's head fixed on a support, important for the elderly population. This system allows to capture data with good temporal resolution (sampling at 360Hz) and good spatial resolution (accuracy of 0.1° of visual angle) at a distance of about 70 cm from the screen test with a visual angle of 32.6°. Results will be processed with ASL Result Software.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
pro-saccade task
Time Frame: session1: after psychiatric and neuropsychologic assessment
The score differences to pro-saccade task between the 3 groups constitute the major research outcome measure used to measure the basic dynamic eye movements.
session1: after psychiatric and neuropsychologic assessment
anti-saccade task
Time Frame: session 2: after session 1 (pro-saccade task)
The score differences to anti-saccade task between the 3 groups consitute one of the major research outcome measure used to measure the basic dynamic eye movements.
session 2: after session 1 (pro-saccade task)
predictive saccade task
Time Frame: session 3: after session 2 (anti-saccade task)
The score differences to predictive saccade tasks between the 3 groups constitute one of the major research outcome measure used to measure the basic dynamic eye movements
session 3: after session 2 (anti-saccade task)
scan of images pair with emotional connotation
Time Frame: session 4 : after session 3 (predictive saccade task)
The score differences of scan of images pair with emotional connotation were used to evaluate the emotional tasks
session 4 : after session 3 (predictive saccade task)
portrait analysis
Time Frame: session 5: after session 4 (scan of images pair with emotional connotation)
The score differences of portrait analysis were used to evaluate the emotional tasks
session 5: after session 4 (scan of images pair with emotional connotation)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Besancon

Collaborators

Centre Hospitalier Universitaire Dijon
Laboratoire de psychologie EA 3188
Centre Hospitalier de Novillars

Investigators

  • Principal Investigator: Pierre VANDEL, Prof, Centre Hospitalier Universitaire de Besançon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2010

Primary Completion (ANTICIPATED)

January 1, 2018

Study Completion (ANTICIPATED)

July 1, 2018

Study Registration Dates

First Submitted

September 14, 2011

First Submitted That Met QC Criteria

September 14, 2011

First Posted (ESTIMATE)

September 15, 2011

Study Record Updates

Last Update Posted (ACTUAL)

July 31, 2017

Last Update Submitted That Met QC Criteria

July 27, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • N/2009/55

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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