Cognitive Disorders and Brain Pulse

Neurocognitive Disorders Clinical Trial

— COG-PULCE  

Official title:

Cognitive Disorders and Brain Pulse

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05129150
• Other study ID #: RIPH3-RNI21-COG PULCE
• Status: Recruiting
• Start date: March 31, 2022
• Est. completion date: March 2031

Study information

• Verified date: June 2024
• Source: University Hospital, Tours
• Contact: Thomas DESMIDT
• Phone: 0234378952
• Email: t.desmidt[@]chu-tours.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: March 2031
• Est. primary completion date: March 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Cognition Disorders
• Cognitive Dysfunction
• Neurocognitive Disorders

Intervention

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.

Locations

Country	Name	City	State
France	University hospital	Tours

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Tours

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	Hippocampal volume	Measured in MRI. Comparison with brain pulse according to Schelten classification	one a year from inclusion visit to 5 years
Secondary	leucoaraiosis load	Measured in MRI. Comparison with brain pulse according to Fazekas classification	one a year from inclusion visit to 5 years
Secondary	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
Secondary	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
Secondary	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