Diagnostic and Prognostic Value of New Quick Tests of Action Slowing in Stroke and in Cognitive Neurodegenerative Disease (QTOAS)

A large series of recent studies have documented the frequency of the slowing of the action in brain diseases, especially vascular and neurodegenerative diseases. In stroke, the predictive value of action slowing at the acute phase for predicting post-stroke functional outcome remains poorly investigated. In neurodegenerative diseases, the diagnostic relevance of the slowing at the prodromal stage remains unknown and this diagnostic requires new tests. Finally, in terms of anatomical determinants, few studies have studied the determinants of action slowing. The objectives of this project are to Determine the diagnostic and prognostic value of action slowing assessed with new quick tests in patients with acute stroke (Neurovascular Unit) and cognitive neurodegenerative disorders (Alzheimer Disease (AD), Lewy Body disease (LBD), Fronto Temporal lobar degeneration (FTLD), Cortico Basal Degeneration (CBD) and Progressive Supra Nuclear Palsy (PSNP)) and to define the lesion determinants with VBM and VLSM

Study Overview

Study Type

Observational

Enrollment (Estimated)

129

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

      • Amiens, France, 80054
        • Recruiting
        • CHU Amiens
        • Contact:
        • Sub-Investigator:
          • Olivier GODEFROY, Pr

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

40 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

acute stroke patients (Stroke Unit) and cognitive neurodegenerative disorder patients (Alzheimer Disease (AD), Lewy Body diseaese (LBD), FrontoTemporal lobar degeneration (FTLD), Cortico Basal Degeneration (CBD) and Progressive SupraNuclear Palsy (PSNP))

Description

Inclusion Criteria:

  • Patients between 40 and 85 years old,
  • French native language,
  • Social Security affiliation.
  • University Memory Clinic for: Mild severity disorder (MMSE> 19) or major severity disorder related to AD : Albert 2011 criteria ; McKhann 2011
  • to MCL according to McKeith criteria
  • to FTLD according to Rascovsky 2011 criteria
  • BBD according to Armstrong's criteria
  • related to PSP according to Höglinger criteria

Exclusion Criteria:

  • Mental retardation or guardianship
  • Previously diagnosed dementia
  • Other current or past brain condition
  • severe head trauma
  • epilepsy prior to stroke still requiring previous treatment
  • Parkinson disease, multiple sclerosis...
  • brain tumor or brain radiation therapy
  • Current or past schizophrenia or psychosis
  • Active or past psychiatric disorders requiring a stay> 2 days in a specialized environment
  • Contra indication to MRI
  • Comorbidity with life expectancy <1 year
  • Comorbidity affecting cognition in particular:
  • Alcohol (> 3 glasses / day) or history of alcohol withdrawal syndrome
  • opiate or cocaine addiction or opiate withdrawal syndrome
  • renal failure (dialysis or creatinine clearance <30)
  • hepatic failure (spontaneous INR> 1.5 or PT <60%)
  • respiratory failure requiring oxygen therapy
  • heart failure (orthopnea> 2 pillows)
  • persistent vigilance disturbances (NIHSS1a score ≤1)
  • cancer with paraneoplastic syndrome
  • treatment with gold salts, D Penicillamine or other treatment with cognitive effect
  • Patient under guardianship or curators or private under public law
  • Pregnant and / or lactating wom

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
Intervention / Treatment
acute stroke patients

New quick tests are

  • Batterie MindPlus (Brevet n° FR1908081, Suarez 2019) is a quick reaction time battery and
  • Minimal Cognitive Evaluation (MCE) test (Sardi et al, 2019) is a cognitive screening tests including a specific assessment of slowing
cognitive neurodegenerative disorders
cognitive neurodegenerative disorders (Alzheimer Disease (AD), Lewy Body disease (LBD), FrontoTemporal lobar degeneration (FTLD), Cortico Basal Degeneration (CBD) and Progressive Supra Nuclear Palsy (PSNP)

New quick tests are

  • Batterie MindPlus (Brevet n° FR1908081, Suarez 2019) is a quick reaction time battery and
  • Minimal Cognitive Evaluation (MCE) test (Sardi et al, 2019) is a cognitive screening tests including a specific assessment of slowing

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Value of the speed of the action with the 'RT Componential Analysis of Action Speed' battery in all patients
Time Frame: 12 months
RT Componential Analysis of Action Speed
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Speed values of action measured in all patients with the "MindPlus" battery in all patients
Time Frame: 12 months
12 months

Collaborators and Investigators

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

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)

July 16, 2021

Primary Completion (Estimated)

July 16, 2027

Study Completion (Estimated)

July 16, 2027

Study Registration Dates

First Submitted

March 14, 2023

First Submitted That Met QC Criteria

March 14, 2023

First Posted (Actual)

March 27, 2023

Study Record Updates

Last Update Posted (Actual)

May 13, 2026

Last Update Submitted That Met QC Criteria

May 12, 2026

Last Verified

May 1, 2026

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

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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