Neurocognitive DisordersCOG-PULCENCT05129150
Cognitive Disorders and Brain Pulse
An observational study of Neurocognitive Disorders, run by University Hospital, Tours at 1 site in France.
Trial summary
Following an initial consultation with a memory, resources and research centre (MRRC) doctor, a day hospital may be prescribed to carry out an assessment of cognitive disorders. Patients are then usually followed up in consultation at least once a year, in the framework of a new day hospital and/or consultations with… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Neurocognitive Disorders
- What is being tested?
- Ultrasound examination
- How many people
- 300 participants
- Where
- 1 siteFrance
- Study dates
- 31 Mar 2022to Mar 2032
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patient benefiting from a day hospital at the MRRC of the CHU of Tours for assessment of cognitive functions
Who may be able to join
- Patient benefiting from a day hospital at the MRRC of the CHU of Tours for assessment of cognitive functions
Who cannot join
- Refusal of TPI ultrasound examination
- Patients who opposed to data processing
- Patients under judicial protection
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
University hospital
Tours, 37044
Thomas DESMIDT, 0234378952 ext. +33, t.desmidt@chu-tours.fr
About this study
Following an initial consultation with a memory, resources and research centre (MRRC) doctor, a day hospital may be prescribed to carry out an assessment of cognitive disorders. Patients are then usually followed up in consultation at least once a year, in the framework of a new day hospital and/or consultations with a MRRC doctor.
Read the detailed description
Patients will be included at the time of the day hospital assessment. All patients received in the day hospital of the MRRC of Tours will be offered the TPI examination. The patients included will be followed up for a period of 5 years and the TPI examination will be repeated according to the same modalities, as part of their follow-up at the MRRC and/or in the context of a new day hospital if necessary.
- Conditions
- Neurocognitive Disorders
- Being tested
- Ultrasound examination
- Keywords
- Brain pulse, ultrasound
- Medical subject headings
- Neurocognitive Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound examinationOther
Ultrasound examination with Tissue Pulsatility Imaging (TPI) TPI is a relatively simple, rapid and non-invasive ultrasound examination which consists of applying a standard ultrasound probe to the acoustic window of the temporal bone to first measure the velocity of the middle cerebral artery in Doppler mode and secondly the cerebral pulsatility (CP) of a region of approximately 10cm2 centred on the middle cerebral artery in B-Echo mode. After collecting the information, the TPI examination will be performed by MRRC staff specially trained in TPI by engineers. The duration of the examination is between 20 and 30 minutes, including hardware installation. Four 30-second PC acquisitions will be collected per examination, with the patient lying supine on the bed in the day hospital room, then one measurement every minute for 3 minutes after standing.
| Study group | Role | What they receive |
|---|---|---|
| assessment of cognitive functions | Assessment of cognitive disorders with an ultrasound examination performed in routine care during a day hospital. Receives: Other: Ultrasound examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
maximum amplitude of brain movements
Measurement by ultrasound between patients with Minor Neurocognitive Disorders (mNCD) and Major Neurocognitive Disorders (MNCD).
Measured: one a year from inclusion visit to 5 years
mean of brain movements
Measurement by ultrasound between patients with Minor Neurocognitive Disorders (mNCD) and Major Neurocognitive Disorders (MNCD).
Measured: one a year from inclusion visit to 5 years
standard deviation of brain movements
Measurement by ultrasound between patients with Minor Neurocognitive Disorders (mNCD) and Major Neurocognitive Disorders (MNCD).
Measured: one a year from inclusion visit to 5 years
powers in frequency analysis
Measurement by ultrasound between patients with Minor Neurocognitive Disorders (mNCD) and Major Neurocognitive Disorders (MNCD).
Measured: one a year from inclusion visit to 5 years
Secondary outcomes (7)
Brain pulse
Longitudinal comparison between converter patients (patients with mNCD progressing to MNCD) and non-converters patients
Measured: one a year from inclusion visit to 5 years
Brain pulse
Cross-sectional and longitudinal analysis between the different types of pathologies underlying NCD (Alzheimer's disease, Vascular NCD, Frontotemporal Lobar Degeneration, Lewy body disease, etc.) according to the Diagnostic and Statistical Manual of mental disorders criteria for these pathologies
Measured: one a year from inclusion visit to 5 years
Hippocampal volume
Measured in MRI. Comparison with brain pulse according to Schelten classification
Measured: one a year from inclusion visit to 5 years
leucoaraiosis load
Measured in MRI. Comparison with brain pulse according to Fazekas classification
Measured: one a year from inclusion visit to 5 years
Carbohydrate metabolism
Measured with PET-FDG in regions of interest involved in neurodegenerative diseases. Comparison with brain pulse
Measured: one a year from inclusion visit to 5 years
Spinal fluid biomarkers
Determination of amyloid and tau proteins in spinal fluid. Comparison with brain pulse
Measured: one a year from inclusion visit to 5 years
cohort study on brain pulsatility with neuropsychological measures
Comparison between brain pulsatility parameters and standard neuropsychological test scores used for cognitive assessment of patients with NCD.
neuropsychological test scores are optional at each visit
Measured: one a year from inclusion visit to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2021
- Study start31 Mar 2022
- Primary completionMar 2027 (estimated)
- Study completionMar 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neurocognitive DisordersStudies of the same condition, open and under way.
- 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
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Tours
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thomas DESMIDT, Principal investigator, University Hospital, Tours
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05129150
- Sponsor's protocol ID
- RIPH3-RNI21-COG PULCE
- Acronym
- COG-PULCE
- Status last verified
- Apr 2026
- First submitted
- 12 Oct 2021
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Disorders and Brain Pulse
- ClinicalTrials.gov ID
- NCT05129150
- Acronym / sponsor ID
- COG-PULCE / RIPH3-RNI21-COG PULCE
- Conditions
- Neurocognitive Disorders
- Keywords
- Brain pulse, ultrasound
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- University Hospital, ToursUniversity, hospital or other
- Study start
- 31 Mar 2022 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2032 (estimated)
- First posted
- 22 Nov 2021 (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.
Following an initial consultation with a memory, resources and research centre (MRRC) doctor, a day hospital may be prescribed to carry out an assessment of cognitive disorders. Patients are then usually followed up in consultation at least once a year, in the framework of a new day hospital and/or consultations with a MRRC doctor.
Detailed description
Patients will be included at the time of the day hospital assessment. All patients received in the day hospital of the MRRC of Tours will be offered the TPI examination. The patients included will be followed up for a period of 5 years and the TPI examination will be repeated according to the same modalities, as part of their follow-up at the MRRC and/or in the context of a new day hospital if necessary.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| assessment of cognitive functions | – | Other: Ultrasound examinationAssessment of cognitive disorders with an ultrasound examination performed in routine care during a day hospital. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patient benefiting from a day hospital at the MRRC of the CHU of Tours for assessment of cognitive functions
Key inclusion criteria (1 listed)
- Patient benefiting from a day hospital at the MRRC of the CHU of Tours for assessment of cognitive functions
Key exclusion criteria (3 listed)
- Refusal of TPI ultrasound examination
- Patients who opposed to data processing
- Patients under judicial protection
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 |
|---|---|---|
| Ultrasound examinationUltrasound examination with Tissue Pulsatility Imaging (TPI) TPI is a relatively simple, rapid and non-invasive ultrasound examination which consists of applying a standard ultrasound probe to the acoustic window of the temporal bone to first measure the velocity of the middle cerebral artery in Doppler mode and secondly the cerebral pulsatility (CP) of a region of approximately 10cm2 centred on the middle cerebral artery in B-Echo mode. After collecting the information, the TPI examination will be performed by MRRC staff specially trained in TPI by engineers. The duration of the examination is between 20 and 30 minutes, including hardware installation. Four 30-second PC acquisitions will be collected per examination, with the patient lying supine on the bed in the day hospital room, then one measurement every minute for 3 minutes after standing. | Other | assessment of cognitive functions |
Primary outcome
maximum amplitude of brain movements
Time frame: one a year from inclusion visit to 5 years
Measurement by ultrasound between patients with Minor Neurocognitive Disorders (mNCD) and Major Neurocognitive Disorders (MNCD).
mean of brain movements
Time frame: one a year from inclusion visit to 5 years
Measurement by ultrasound between patients with Minor Neurocognitive Disorders (mNCD) and Major Neurocognitive Disorders (MNCD).
standard deviation of brain movements
Time frame: one a year from inclusion visit to 5 years
Measurement by ultrasound between patients with Minor Neurocognitive Disorders (mNCD) and Major Neurocognitive Disorders (MNCD).
powers in frequency analysis
Time frame: one a year from inclusion visit to 5 years
Measurement by ultrasound between patients with Minor Neurocognitive Disorders (mNCD) and Major Neurocognitive Disorders (MNCD).
7 secondary outcomes
Brain pulse
Time frame: one a year from inclusion visit to 5 years
Brain pulse
Time frame: one a year from inclusion visit to 5 years
Hippocampal volume
Time frame: one a year from inclusion visit to 5 years
leucoaraiosis load
Time frame: one a year from inclusion visit to 5 years
Carbohydrate metabolism
Time frame: one a year from inclusion visit to 5 years
Spinal fluid biomarkers
Time frame: one a year from inclusion visit to 5 years
cohort study on brain pulsatility with neuropsychological measures
Time frame: one a year from inclusion visit to 5 years
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 6 May 2026.
- Individual participant dataSharing planned: Undecided
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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.
Thomas DESMIDT principal investigator
University Hospital, Tours
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 Neurocognitive Disorders, run by University Hospital, Tours 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 1 inclusion and 3 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 6 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 Thomas DESMIDT (0234378952 ext. +33, t.desmidt@chu-tours.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
maximum amplitude of brain movements (time frame: one a year from inclusion visit to 5 years). The study lists 4 primary outcomes in all. 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 6 May 2026.