Clinical Validation of the Bordeaux Maze Test (BORMATE)

January 22, 2020 updated by: Parc de Salut Mar
Currently, the instruments used in translational studies related to cognition have proved to be inaccurate. For this reason, the objective of this study is to evaluate whether the Bordeaux Maze Test has adequate psychometric properties and is valid for its use to compare trials tested in preclinical (animal) studies and clinical population with Down syndrome. Specifically, it is intended to study the domains of memory (relational memory) and executive functions (work memory), both relevant in the cognitive functioning of the population with Down syndrome.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

50

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

  • Name: Rafael de la Torre, Prof
  • Phone Number: +34933160484
  • Email: rtorre@imim.es

Study Locations

      • Barcelona, Spain, 08003
        • Recruiting
        • IMIM (Institut Hospital del Mar d'Investigacions Mèdiques)
        • Principal Investigator:
          • Rafael de la Torre, PhD

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

16 years to 35 years (ADULT, CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Down syndrome volunteers are recruited from Down syndrome foundations and control volunteers from educational centres nearby the research institute.

Description

Inclusion Criteria:

  • Down syndrome population:

    • Males and females aged 16 to 35 years.
    • Clinical diagnosis of DS (full trisomy 21 or translocated) confirmed by chromosomal analysis (karyotyping).
    • Parent or legal guardian/representative and caregiver willing to give written informed consent.
    • Study participants must have sufficient vision and hearing to participate in study evaluations. Mild hearing loss will be allowed.
    • Availability of parent/caregiver to accompany the subject to clinical visits.
    • Subjects must be able to understand basic instructions.
    • Parent or legal guardian/representative and caregiver willing to give written informed consent
  • Normotypical population:

    • Males and females aged 18 to 35 years.
    • Clinical history and physical examination demonstrating no organic or psychiatric disorders.
    • Understanding and accepting the study procedures and signing the informed consent.

Exclusion Criteria:

  • Study participants with a current DSM-5 (Diagnostic and Statistical Manual of Mental Disorders) diagnosis of any primary or secondary psychiatric diagnoses (such as autism spectrum disorder, attention deficit hyperactivity disorder, depression and conduct disorder). Participation are allowed as long as they are considered stable and their medication with a regime that does not change in the 6 weeks prior to enrolment and does not interfere with the progression of the study.
  • Subjects with evidence of dementia or meeting clinical diagnoses for dementia.
  • Subjects thyroid dysfunction or diabetes that is not adequately controlled or stabilized on treatment for at least 8 weeks prior to randomization.
  • Personal history of infantile spasms, of epilepsy, of severe head trauma or Central Nervous System (CNS) infections (e.g. meningitis), with the exception of a single isolated febrile seizure.
  • Subjects with past history of seizures from primary causes (such as West syndrome and Lennox-Gastaut syndrome) or secondary causes.
  • Clinical history of moderate or severe Obstructive Sleep Apnea (OSA) as defined by Apnea-Hypopnea Index (AHI) (>15 events per hour not well controlled by positive airway pressure therapy with stable settings) for at least 3 months prior to screening visit.
  • Alcohol and/or substance use disorder in the past year.
  • Concomitant disease or condition or any clinically significant finding at screening that could interfere with the conduct of the study, or that would, in the opinion of the investigator, could lead to an unacceptable risk to the subject in this study.
  • Participation in other clinical trials in the last 3 months prior to the study.

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

Cohorts and Interventions

Group / Cohort
Down syndrome volunteers
Males and females from 16 to 35 years
Healthy volunteers
Males and females from 18 to 35 years

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Validation of the Bordeaux Maze Test
Time Frame: Changes from months 0 to months 1 and 3
To validate a novel neuropsychological test, the Bordeaux Maze Test for the evaluation of working memory in subjects with Down syndrome (DS)
Changes from months 0 to months 1 and 3

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Test retest reliability
Time Frame: months 0, 1 and 3
To validate the Bordeaux Maze Test, for the evaluation of cognitive flexibility in subjects with Down syndrome (DS)
months 0, 1 and 3
Criteria validity
Time Frame: months 0, 1 and 3
To evaluate the influence of age and gender on the Bordeaux Maze Test in the Down syndrome population;
months 0, 1 and 3
Analyses of the stability: Learning and practice effects observe on the Bordeaux Maze Test
Time Frame: months 0, 1 and 3
To evaluate the relevance of learning/practice effects
months 0, 1 and 3
Analyses of the stability: Learning and practice effects observe on the NIH Toolbox
Time Frame: months 0, 1 and 3
To evaluate the relevance of learning/practice effects
months 0, 1 and 3
Analyses of the stability: Floor/ ceiling effects on the Bordeaux Maze Test
Time Frame: months 0, 1 and 3
To evaluate the relevance of floor/ceiling effects
months 0, 1 and 3
Analyses of the stability: Floor/ ceiling effects on the NIH Toolbox
Time Frame: months 0, 1 and 3
To evaluate the relevance of floor/ceiling effects
months 0, 1 and 3

Collaborators and Investigators

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

Collaborators

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 (ACTUAL)

April 5, 2019

Primary Completion (ANTICIPATED)

April 1, 2020

Study Completion (ANTICIPATED)

April 1, 2020

Study Registration Dates

First Submitted

November 13, 2019

First Submitted That Met QC Criteria

January 22, 2020

First Posted (ACTUAL)

January 27, 2020

Study Record Updates

Last Update Posted (ACTUAL)

January 27, 2020

Last Update Submitted That Met QC Criteria

January 22, 2020

Last Verified

October 1, 2019

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

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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