Diagnostic and Prognostic Value of New Quick Tests of Action Slowing in Stroke and in Cognitive N… (NCT05785156) | Clinical Trial Compass
RecruitingNot Applicable
Diagnostic and Prognostic Value of New Quick Tests of Action Slowing in Stroke and in Cognitive Neurodegenerative Disease
France129 participantsStarted 2021-07-16
Plain-language 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
Who can participate
Age range
40 Years – 85 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 ef…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Value of the speed of the action with the 'RT Componential Analysis of Action Speed' battery in all patients