Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05785156
Other study ID # PI2021_843_0082
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


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
See also
  Status Clinical Trial Phase
Recruiting NCT04043052 - Mobile Technologies and Post-stroke Depression N/A
Recruiting NCT03869138 - Alternative Therapies for Improving Physical Function in Individuals With Stroke N/A
Completed NCT04034069 - Effects of Priming Intermittent Theta Burst Stimulation on Upper Limb Motor Recovery After Stroke: A Randomized Controlled Trial N/A
Completed NCT04101695 - Hemodynamic Response of Anodal Transcranial Direct Current Stimulation Over the Cerebellar Hemisphere in Healthy Subjects N/A
Terminated NCT03052712 - Validation and Standardization of a Battery Evaluation of the Socio-emotional Functions in Various Neurological Pathologies N/A
Completed NCT00391378 - Cerebral Lesions and Outcome After Cardiac Surgery (CLOCS) N/A
Recruiting NCT06204744 - Home-based Arm and Hand Exercise Program for Stroke: A Multisite Trial N/A
Active, not recruiting NCT06043167 - Clinimetric Application of FOUR Scale as in Treatment and Rehabilitation of Patients With Acute Cerebral Injury
Active, not recruiting NCT04535479 - Dry Needling for Spasticity in Stroke N/A
Completed NCT03985761 - Utilizing Gaming Mechanics to Optimize Telerehabilitation Adherence in Persons With Stroke N/A
Recruiting NCT00859885 - International PFO Consortium N/A
Recruiting NCT06034119 - Effects of Voluntary Adjustments During Walking in Participants Post-stroke N/A
Completed NCT03622411 - Tablet-based Aphasia Therapy in the Chronic Phase N/A
Completed NCT01662960 - Visual Feedback Therapy for Treating Individuals With Hemiparesis Following Stroke N/A
Recruiting NCT05854485 - Robot-Aided Assessment and Rehabilitation of Upper Extremity Function After Stroke N/A
Active, not recruiting NCT05520528 - Impact of Group Participation on Adults With Aphasia N/A
Completed NCT03366129 - Blood-Brain Barrier Disruption in People With White Matter Hyperintensities Who Have Had a Stroke
Completed NCT03281590 - Stroke and Cerebrovascular Diseases Registry
Completed NCT05805748 - Serious Game Therapy in Neglect Patients N/A
Recruiting NCT05621980 - Finger Movement Training After Stroke N/A