Skip to content

Cognitive Disorders and Brain Pulse

Cognitive Disorders and Brain Pulse

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05129150
Acronym
COG-PULCE
Enrollment
300
Registered
2021-11-22
Start date
2022-03-31
Completion date
2032-03-01
Last updated
2026-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neurocognitive Disorders

Keywords

Brain pulse, ultrasound

Brief 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.

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.

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.

Sponsors

University Hospital, Tours
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
maximum amplitude of brain movementsone a year from inclusion visit to 5 yearsMeasurement by ultrasound between patients with Minor Neurocognitive Disorders (mNCD) and Major Neurocognitive Disorders (MNCD).
mean of brain movementsone a year from inclusion visit to 5 yearsMeasurement by ultrasound between patients with Minor Neurocognitive Disorders (mNCD) and Major Neurocognitive Disorders (MNCD).
standard deviation of brain movementsone a year from inclusion visit to 5 yearsMeasurement by ultrasound between patients with Minor Neurocognitive Disorders (mNCD) and Major Neurocognitive Disorders (MNCD).
powers in frequency analysisone a year from inclusion visit to 5 yearsMeasurement by ultrasound between patients with Minor Neurocognitive Disorders (mNCD) and Major Neurocognitive Disorders (MNCD).

Secondary

MeasureTime frameDescription
Brain pulseone a year from inclusion visit to 5 yearsLongitudinal comparison between converter patients (patients with mNCD progressing to MNCD) and non-converters patients
Hippocampal volumeone a year from inclusion visit to 5 yearsMeasured in MRI. Comparison with brain pulse according to Schelten classification
leucoaraiosis loadone a year from inclusion visit to 5 yearsMeasured in MRI. Comparison with brain pulse according to Fazekas classification
Carbohydrate metabolismone a year from inclusion visit to 5 yearsMeasured with PET-FDG in regions of interest involved in neurodegenerative diseases. Comparison with brain pulse
Spinal fluid biomarkersone a year from inclusion visit to 5 yearsDetermination of amyloid and tau proteins in spinal fluid. Comparison with brain pulse
cohort study on brain pulsatility with neuropsychological measuresone a year from inclusion visit to 5 yearsComparison 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

Countries

France

Contacts

CONTACTThomas DESMIDT
t.desmidt@chu-tours.fr0234378952
CONTACTDominique BOMIA
d.bomia@chu-tours.fr0247479785
PRINCIPAL_INVESTIGATORThomas DESMIDT

University Hospital, Tours

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 7, 2026