StrokeQTOASNCT05785156
Diagnostic and Prognostic Value of New Quick Tests of Action Slowing in Stroke and in Cognitive Neurodegenerative Disease
An observational study of Stroke and Action Speed, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- Stroke, Action Speed, Dementia Mild Cognitive Impairment
- What is being tested?
- quick tests
- How many people
- 129 participants
- Where
- 1 siteFrance
- Study dates
- 16 Jul 2021to 16 Jul 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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))
Who may be able to join
- 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
Who cannot join
- 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...
Show all 23Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU Amiens
Amiens, 80054
Martine Roussel, PhD, 0322667813, roussel.martine@chu-amiens.fr
Olivier GODEFROY, Pr
About this study
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
- Being tested
- quick tests
- Keywords
- executive processes, attention, Stroke, action speed, Diagnostic, sensitivity, specificity, dementia mild cognitive impairment, Alzheimer disease
- Medical subject headings
- Stroke, Alzheimer Disease, Disease, Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
quick testsOther
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
| Study group | Role | What they receive |
|---|---|---|
| acute stroke patients | Not described Receives: Other: quick tests | |
| 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) Receives: Other: quick tests |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 months
Secondary outcomes (1)
Speed values of action measured in all patients with the "MindPlus" battery in all patients
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2023
- Study start16 Jul 2021
- Primary completion16 Jul 2027 (estimated)
- Study completion16 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire, AmiensThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 129 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05785156
- Sponsor's protocol ID
- PI2021_843_0082
- Acronym
- QTOAS
- Status last verified
- May 2026
- First submitted
- 14 Mar 2023
- Last updated
- 13 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic and Prognostic Value of New Quick Tests of Action Slowing in Stroke and in Cognitive Neurodegenerative Disease
- ClinicalTrials.gov ID
- NCT05785156
- Acronym / sponsor ID
- QTOAS / PI2021_843_0082
- Keywords
- executive processes, attention, Stroke, action speed, Diagnostic, sensitivity, specificity, dementia mild cognitive impairment
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 129 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- 16 Jul 2021 (actual)
- Primary completion
- 16 Jul 2027 (estimated)
- Study completion
- 16 Jul 2027 (estimated)
- First posted
- 27 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| acute stroke patients | – | Other: quick tests |
| cognitive neurodegenerative disorders | – | Other: quick testscognitive neurodegenerative disorders (Alzheimer Disease (AD), Lewy Body disease (LBD), FrontoTemporal lobar degeneration (FTLD), Cortico Basal Degeneration (CBD) and Progressive Supra Nuclear Palsy (PSNP) |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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))
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (23 listed)
- Mental retardation or guardianship
- Previously diagnosed dementia
- Other current or past brain condition
- severe head trauma
- epilepsy prior to stroke still requiring previous treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| quick testsNew 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 | Other | acute stroke patients, cognitive neurodegenerative disorders |
Primary outcome
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
1 secondary outcome
Speed values of action measured in all patients with the "MindPlus" battery in all patients
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke and Action Speed, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Martine ROUSSEL, PhD (0322667813, roussel.martine@chu-amiens.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Value of the speed of the action with the 'RT Componential Analysis of Action Speed' battery in all patients (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2026.