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Recruiting NCT05129150

Cognitive Disorders and Brain Pulse

Observational Neurocognitive Disorders

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Ultrasound examination.
Who it may be relevant to
Registry conditions: Neurocognitive Disorders. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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

  • 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

Primary outcome measures

  • maximum amplitude of brain movements [Time frame: one a year from inclusion visit to 5 years]
  • mean of brain movements [Time frame: one a year from inclusion visit to 5 years]
  • standard deviation of brain movements [Time frame: one a year from inclusion visit to 5 years]
  • powers in frequency analysis [Time frame: one a year from inclusion visit to 5 years]
Secondary outcome measures (7)
  • 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-only

Study locations

France · 1 center
  • University hospital — Tours

Identifiers

NCT: NCT05129150 · RIPH3-RNI21-COG PULCE

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗