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Eye Movement and Cognitive Dysfunction (EMCD)

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ClinicalTrials.gov Identifier: NCT04236375
Recruitment Status : Not yet recruiting
First Posted : January 22, 2020
Last Update Posted : January 22, 2020
Sponsor:
Information provided by (Responsible Party):
Haotian Lin, Sun Yat-sen University

Brief Summary:
There is association between eye movement disorder and cognitive dysfunction. Therefore, utilizing eye movement and screening for cognitive dysfunction is feasible. In the present study, we will develop an artificial intelligence platform to screening for cognitive dysfunction by inspecting the function of eye movement. Futher more, based on the screening results, the platform will offer referral suggestions.

Condition or disease
Eye Movement Disorder Cognitive Dysfunction

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Study Type : Observational
Estimated Enrollment : 700 participants
Observational Model: Case-Crossover
Time Perspective: Cross-Sectional
Official Title: The Development of an Artificial Intelligence Platform for Screening and Referral of Cognitive Dysfunction
Estimated Study Start Date : February 1, 2020
Estimated Primary Completion Date : August 1, 2020
Estimated Study Completion Date : December 1, 2020

Resource links provided by the National Library of Medicine


Group/Cohort
Normal
Subjects over 45 years old without cognitive dysfunction
Mild cognitive decline
Subjects who are diagnosed as mild cognitive decline(MCI) according to neurologists.
Alzheimer's disease
Subjects who are diagnosed as Alzheimer's disease(AD) according to neurologists.
Vascular dementia
Subjects who are diagnosed as vascular dementia(VD) according to neurologists.
Lewy body dementia
Subjects who are diagnosed as Lewy body demenita (DLB) according to neurologists.
Frontotemporal dementia
Subjects who are diagnosed as Frontotemporal demenita (FD) according to neurologists.
Other dementia
Subjects who are diagnosed as dementia but are not as AD, VD, DLB OR FD.



Primary Outcome Measures :
  1. Area under the curve [ Time Frame: up to 1 month ]
    AUC values for predicting whether subject has cognitive impairment or not


Secondary Outcome Measures :
  1. Accuracy, true positive rate, and true negetive rate [ Time Frame: up to 1 month ]
    The performance of this artificial platform



Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Subjects who are over 45 years old with or without cognitive dysfunction.
Criteria

Inclusion Criteria:

  • ①Subjects who are diagnosed as mild cognitive decline, Alzheimer's disease, Vascular dementia, Lewy body dementia, Frontotemporal dementia, other dementia and normal by neurologist.
  • ②Subjects who can cooperate with the inspection.
  • ③Subjects who agree to participate in the study and sign the consent form

Exclusion Criteria:

  • ①Subjects who cannot do the inspection.
  • ②Subjects who suffer from diseases that compromise the inspection.

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): NCT04236375


Contacts
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Contact: Haotian Lin, M.D.,Ph.D 86-13802793086 gddlht@aliyun.com

Sponsors and Collaborators
Sun Yat-sen University
Investigators
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Study Chair: Haotian Lin, M.D.,Ph.D Zhongshan Ophthalmic Center, Sun Yat-sen University
Study Director: Xun Wang, M.D.,Ph.D Zhongshan Ophthalmic Center, Sun Yat-sen University
Principal Investigator: Shuyi Zhang, M.D. Zhongshan Ophthalmic Center, Sun Yat-sen University
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Responsible Party: Haotian Lin, Professor, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT04236375    
Other Study ID Numbers: Eye movement-cognitive decline
First Posted: January 22, 2020    Key Record Dates
Last Update Posted: January 22, 2020
Last Verified: January 2020

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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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Movement Disorders
Ocular Motility Disorders
Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Mental Disorders
Central Nervous System Diseases
Nervous System Diseases
Cranial Nerve Diseases
Eye Diseases