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RecruitingNCT05129150COG-PULCEUpdated May 6, 2026

Cognitive Disorders and Brain Pulse

An observational study in Neurocognitive Disorders, sponsored by University Hospital, Tours. Recruiting at 1 site in France. Per ClinicalTrials.gov, last updated 2026-05-06.

Sponsored by University Hospital, Tours · Observational

From the registry’s dates

  • Started Mar 2022; still recruiting 4 years 6 months later.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
300
Sex
All
01

Study 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 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.

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Conditions studied

  • Neurocognitive Disorders

Keywords

  • Brain pulse
  • ultrasound
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In context

Neurocognitive Disorders

246 studies on the registry are indexed under Neurocognitive Disorders; 88 are open to participants now.

This study's planned enrollment of 300 is above the median of 165 across 93 observational studies indexed under Neurocognitive Disorders.

Browse Neurocognitive Disorders studies →

Lead sponsor

University Hospital, Tours is the lead sponsor of 304 studies on the registry; 78 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patient benefiting from a day hospital at the MRRC of the CHU of Tours for assessment of cognitive functions

Inclusion criteria

  • Patient benefiting from a day hospital at the MRRC of the CHU of Tours for assessment of cognitive functions

Exclusion criteria

Exclusion Criteria:

  • Refusal of TPI ultrasound examination
  • Patients who opposed to data processing
  • Patients under judicial protection
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Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
300 participants (estimated)
Patient registry
No

Groups and cohorts

  • assessment of cognitive functions

    Assessment of cognitive disorders with an ultrasound examination performed in routine care during a day hospital.

    Other: Ultrasound examination

Interventions

  • OtherUltrasound examination

    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.

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What researchers measure

Primary outcomes

  1. maximum amplitude of brain movements

    Measurement by ultrasound between patients with Minor Neurocognitive Disorders (mNCD) and Major Neurocognitive Disorders (MNCD).

    Time frame: one a year from inclusion visit to 5 years

  2. mean of brain movements

    Measurement by ultrasound between patients with Minor Neurocognitive Disorders (mNCD) and Major Neurocognitive Disorders (MNCD).

    Time frame: one a year from inclusion visit to 5 years

  3. standard deviation of brain movements

    Measurement by ultrasound between patients with Minor Neurocognitive Disorders (mNCD) and Major Neurocognitive Disorders (MNCD).

    Time frame: one a year from inclusion visit to 5 years

  4. powers in frequency analysis

    Measurement by ultrasound between patients with Minor Neurocognitive Disorders (mNCD) and Major Neurocognitive Disorders (MNCD).

    Time frame: one a year from inclusion visit to 5 years

Secondary outcomes

  1. Brain pulse

    Longitudinal comparison between converter patients (patients with mNCD progressing to MNCD) and non-converters patients

    Time frame: one a year from inclusion visit to 5 years

  2. 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

    Time frame: one a year from inclusion visit to 5 years

  3. Hippocampal volume

    Measured in MRI. Comparison with brain pulse according to Schelten classification

    Time frame: one a year from inclusion visit to 5 years

  4. leucoaraiosis load

    Measured in MRI. Comparison with brain pulse according to Fazekas classification

    Time frame: one a year from inclusion visit to 5 years

  5. Carbohydrate metabolism

    Measured with PET-FDG in regions of interest involved in neurodegenerative diseases. Comparison with brain pulse

    Time frame: one a year from inclusion visit to 5 years

  6. Spinal fluid biomarkers

    Determination of amyloid and tau proteins in spinal fluid. Comparison with brain pulse

    Time frame: one a year from inclusion visit to 5 years

  7. 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

    Time frame: one a year from inclusion visit to 5 years

07

Study locations

1 of 1 sites recruiting
  • University hospital
    Tours, 37044, France
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 6, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05129150
Lead sponsor
University Hospital, Tours
Responsible party
Sponsor
First posted
Nov 22, 2021
Start date
Mar 31, 2022
Primary completion
Mar 2027 (estimated)
Completion
Mar 2032 (estimated)
Last update
May 6, 2026

Study contacts

Thomas DESMIDT
Contact
t.desmidt@chu-tours.fr
0234378952 ext. +33
Dominique BOMIA
Contact
d.bomia@chu-tours.fr
0247479785 ext. +33
Thomas DESMIDT
principal investigator · University Hospital, Tours

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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