- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05785156
Diagnostic and Prognostic Value of New Quick Tests of Action Slowing in Stroke and in Cognitive Neurodegenerative Disease (QTOAS)
May 12, 2026 updated by: Centre Hospitalier Universitaire, Amiens
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
Status
Recruiting
Intervention / Treatment
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
- Name: Martine Roussel, PhD
- Phone Number: 0322667813
- Email: roussel.martine@chu-amiens.fr
Study Locations
-
-
-
Amiens, France, 80054
- Recruiting
- CHU Amiens
-
Contact:
- Martine Roussel, PhD
- Phone Number: 0322667813
- Email: roussel.martine@chu-amiens.fr
-
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
|
|
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
|
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
Keywords
Additional Relevant MeSH Terms
- Cerebrovascular Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Vascular Diseases
- Cardiovascular Diseases
- Mental Disorders
- Pathologic Processes
- Immune System Diseases
- Neurocognitive Disorders
- Dementia
- Tauopathies
- Neurodegenerative Diseases
- Pathological Conditions, Signs and Symptoms
- Stroke
- Alzheimer Disease
- Hypersensitivity
- Disease
Other Study ID Numbers
- PI2021_843_0082
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.