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

Stroke Clinical Trial

— QTOAS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05785156
• Other study ID #: PI2021_843_0082
• Status: Recruiting
• Start date: July 16, 2021
• Est. completion date: July 2025

Study information

• Verified date: March 2023
• Source: Centre Hospitalier Universitaire, Amiens
• Contact: Martine ROUSSEL, PhD
• Phone: 0322667813
• Email: roussel.martine[@]chu-amiens.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 129
• Est. completion date: July 2025
• Est. primary completion date: July 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Alzheimer Disease
• Cognitive Dysfunction
• Dementia
• Neurodegenerative Diseases
• Stroke

Intervention

Other:
• quick tests
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

Locations

Country	Name	City	State
France	CHU Amiens	Amiens

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire, Amiens

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Value of the speed of the action with the 'RT Componential Analysis of Action Speed' battery in all patients	RT Componential Analysis of Action Speed	12 months
Secondary	Speed values of action measured in all patients with the "MindPlus" battery in all patients		12 months