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NCT Number: NCT05129150

Cognitive Disorders and Brain Pulse

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.

Recruiting

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Key information

Conditions

Neurocognitive Disorders Mental Disorders

Sex eligibility

All sexes

Study type

Observational

Primary location

University hospital

Tours, 37044, France

Location status: Recruiting

Location contact

Thomas DESMIDT

CONTACT

[email protected]

0234378952 ext. +33

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Ultrasound examination

Other

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.

Primary outcomes

  1. 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).

  2. 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).

  3. 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).

  4. 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).

Secondary outcomes

  1. Brain pulse

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

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

  2. Brain pulse

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

    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

  3. Hippocampal volume

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

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

  4. leucoaraiosis load

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

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

  5. Carbohydrate metabolism

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

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

  6. Spinal fluid biomarkers

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

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

  7. cohort study on brain pulsatility with neuropsychological measures

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

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Dominique BOMIA

CONTACT

[email protected]

0247479785 ext. +33

Thomas DESMIDT

CONTACT

[email protected]

0234378952 ext. +33

Sponsors and collaborators

Lead sponsor

University Hospital, Tours

Other

Registry information

Acronym: COG-PULCE

Important dates

Study start
2022
Primary completion
2027
Study completion
2032
First posted
Nov 22, 2021
Registry last updated
May 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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