NCT05129150

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
68mo left

Started Mar 2022

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress44%
Mar 2022Mar 2032

First Submitted

Initial submission to the registry

October 12, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 22, 2021

Completed
4 months until next milestone

Study Start

First participant enrolled

March 31, 2022

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2027

Expected
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2032

Last Updated

May 6, 2026

Status Verified

April 1, 2026

Enrollment Period

4.9 years

First QC Date

October 12, 2021

Last Update Submit

April 29, 2026

Conditions

Neurocognitive Disorders

Keywords

Brain pulseultrasound

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (7)

  • Brain pulse

    one a year from inclusion visit to 5 years

  • Brain pulse

    one a year from inclusion visit to 5 years

  • Hippocampal volume

    one a year from inclusion visit to 5 years

  • leucoaraiosis load

    one a year from inclusion visit to 5 years

  • Carbohydrate metabolism

    one a year from inclusion visit to 5 years

  • +2 more secondary outcomes

Study Arms (1)

assessment of cognitive functions

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

Other: Ultrasound examination

Interventions

Ultrasound examinationOTHER

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.

assessment of cognitive functions

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patient benefiting from a day hospital at the MRRC of the CHU of Tours for assessment of cognitive functions

You may qualify if:

  • Patient benefiting from a day hospital at the MRRC of the CHU of Tours for assessment of cognitive functions

You may not qualify if:

  • Refusal of TPI ultrasound examination
  • Patients who opposed to data processing
  • Patients under judicial protection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University hospital

Tours, 37044, France

RECRUITING

MeSH Terms

Conditions

Neurocognitive Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

  • Thomas DESMIDT

    University Hospital, Tours

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Thomas DESMIDT

CONTACT

0234378952t.desmidt@chu-tours.fr

Dominique BOMIA

CONTACT

0247479785d.bomia@chu-tours.fr

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 12, 2021

First Posted

November 22, 2021

Study Start

March 31, 2022

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

March 1, 2032

Last Updated

May 6, 2026

Record last verified: 2026-04

Locations

FR(1)