Cognitive Disorders and Brain Pulse
ConditionNeurocognitive Disorders
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorUniversity Hospital, Tours
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patient benefiting from a day hospital at the MRRC of the CHU of Tours for assessment of cognitive functions
Disqualifiers
Refusal of TPI ultrasound examination
Patients who opposed to data processing
Patients under judicial protection
Trial population
Patient benefiting from a day hospital at the MRRC of the CHU of Tours for assessment of cognitive functions
Trial design
Design model
Case-only
Time perspective
Prospective
Treatments tested in this trial
Ultrasound examination
Other interventionUltrasound 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.
Treatment groups
300 Participants
are divided into 1 treatment groupGroup A: assessment of cognitive functions1 intervention
Trial outcomes
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 years2
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 years3
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 years4
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 yearsSecondary 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 years2
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 years3
Hippocampal volume
Measured in MRI. Comparison with brain pulse according to Schelten classification
Time frame
one a year from inclusion visit to 5 years4
leucoaraiosis load
Measured in MRI. Comparison with brain pulse according to Fazekas classification
Time frame
one a year from inclusion visit to 5 yearsSponsors and contacts
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Source ClinicalTrials.gov