Cognitive Disorders and Brain Pulse (COG-PULCE)

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.

Study Overview

• Status: Recruiting
• Conditions: Neurocognitive Disorders
• Intervention / Treatment: Other: Ultrasound examination

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 Type: Observational
• Enrollment (Estimated): 300

Contacts and Locations

• Study Contact: Name: Thomas DESMIDT; Phone Number: +33 0234378952; Email: t.desmidt@chu-tours.fr
• Study Contact Backup: Name: Dominique BOMIA; Phone Number: +33 0247479785; Email: d.bomia@chu-tours.fr

Study Locations

• France
  • Tours, France, 37044
    • Recruiting
    • University Hospital
    • Contact: Thomas DESMIDT; Phone Number: +33 0234378952; Email: t.desmidt@chu-tours.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• 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

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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

Other: Ultrasound 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
maximum amplitude of brain movements	Measurement by ultrasound between patients with Minor Neurocognitive Disorders (mNCD) and Major Neurocognitive Disorders (MNCD).	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).	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).	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).	one a year from inclusion visit to 5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Brain pulse	Longitudinal comparison between converter patients (patients with mNCD progressing to MNCD) and non-converters patients	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	one a year from inclusion visit to 5 years
Hippocampal volume	Measured in MRI. Comparison with brain pulse according to Schelten classification	one a year from inclusion visit to 5 years
leucoaraiosis load	Measured in MRI. Comparison with brain pulse according to Fazekas classification	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	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	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	one a year from inclusion visit to 5 years

Collaborators and Investigators

• Sponsor: University Hospital, Tours
• Investigators: Principal Investigator: Thomas DESMIDT, University Hospital, Tours

Study record dates

Study Major Dates

• Study Start (Actual): March 31, 2022
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2032

Study Registration Dates

• First Submitted: October 12, 2021
• First Submitted That Met QC Criteria: November 10, 2021
• First Posted (Actual): November 22, 2021

Study Record Updates

• Last Update Posted (Actual): May 6, 2026
• Last Update Submitted That Met QC Criteria: April 29, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: ultrasound; Brain pulse
• Additional Relevant MeSH Terms: Mental Disorders; Neurocognitive Disorders
• Other Study ID Numbers: RIPH3-RNI21-COG PULCE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No