Ignite Creation Date:
2025-12-24 @ 4:48 PM
Ignite Modification Date:
2026-01-15 @ 7:07 PM
Study NCT ID:
NCT05129150
Status:
RECRUITING
Last Update Posted:
2025-08-11
First Post:
2021-10-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cognitive Disorders and Brain Pulse
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019965', 'term': 'Neurocognitive Disorders'}], 'ancestors': [{'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-03-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2031-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-05', 'studyFirstSubmitDate': '2021-10-12', 'studyFirstSubmitQcDate': '2021-11-10', 'lastUpdatePostDateStruct': {'date': '2025-08-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-11-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'maximum amplitude of brain movements', 'timeFrame': 'one a year from inclusion visit to 5 years', 'description': 'Measurement by ultrasound between patients with Minor Neurocognitive Disorders (mNCD) and Major Neurocognitive Disorders (MNCD).'}, {'measure': 'mean of brain movements', 'timeFrame': 'one a year from inclusion visit to 5 years', 'description': 'Measurement by ultrasound between patients with Minor Neurocognitive Disorders (mNCD) and Major Neurocognitive Disorders (MNCD).'}, {'measure': 'standard deviation of brain movements', 'timeFrame': 'one a year from inclusion visit to 5 years', 'description': 'Measurement by ultrasound between patients with Minor Neurocognitive Disorders (mNCD) and Major Neurocognitive Disorders (MNCD).'}, {'measure': 'powers in frequency analysis', 'timeFrame': 'one a year from inclusion visit to 5 years', 'description': 'Measurement by ultrasound between patients with Minor Neurocognitive Disorders (mNCD) and Major Neurocognitive Disorders (MNCD).'}], 'secondaryOutcomes': [{'measure': 'Brain pulse', 'timeFrame': 'one a year from inclusion visit to 5 years', 'description': 'Longitudinal comparison between converter patients (patients with mNCD progressing to MNCD) and non-converters patients'}, {'measure': 'Brain pulse', 'timeFrame': 'one a year from inclusion visit to 5 years', 'description': "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"}, {'measure': 'Hippocampal volume', 'timeFrame': 'one a year from inclusion visit to 5 years', 'description': 'Measured in MRI. Comparison with brain pulse according to Schelten classification'}, {'measure': 'leucoaraiosis load', 'timeFrame': 'one a year from inclusion visit to 5 years', 'description': 'Measured in MRI. Comparison with brain pulse according to Fazekas classification'}, {'measure': 'Carbohydrate metabolism', 'timeFrame': 'one a year from inclusion visit to 5 years', 'description': 'Measured with PET-FDG in regions of interest involved in neurodegenerative diseases. Comparison with brain pulse'}, {'measure': 'Spinal fluid biomarkers', 'timeFrame': 'one a year from inclusion visit to 5 years', 'description': 'Determination of amyloid and tau proteins in spinal fluid. Comparison with brain pulse'}, {'measure': 'cohort study on brain pulsatility with neuropsychological measures', 'timeFrame': 'one a year from inclusion visit to 5 years', 'description': 'Comparison between brain pulsatility parameters and standard neuropsychological test scores used for cognitive assessment of patients with NCD.\n\nneuropsychological test scores are optional at each visit'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Brain pulse', 'ultrasound'], 'conditions': ['Neurocognitive Disorders']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patient benefiting from a day hospital at the MRRC of the CHU of Tours for assessment of cognitive functions', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient benefiting from a day hospital at the MRRC of the CHU of Tours for assessment of cognitive functions\n\nExclusion Criteria:\n\n* Refusal of TPI ultrasound examination\n* Patients who opposed to data processing\n* Patients under judicial protection'}, 'identificationModule': {'nctId': 'NCT05129150', 'acronym': 'COG-PULCE', 'briefTitle': 'Cognitive Disorders and Brain Pulse', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Tours'}, 'officialTitle': 'Cognitive Disorders and Brain Pulse', 'orgStudyIdInfo': {'id': 'RIPH3-RNI21-COG PULCE'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'assessment of cognitive functions', 'description': 'Assessment of cognitive disorders with an ultrasound examination performed in routine care during a day hospital.', 'interventionNames': ['Other: Ultrasound examination']}], 'interventions': [{'name': 'Ultrasound examination', 'type': 'OTHER', 'description': '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.', 'armGroupLabels': ['assessment of cognitive functions']}]}, 'contactsLocationsModule': {'locations': [{'zip': '37044', 'city': 'Tours', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Thomas DESMIDT', 'role': 'CONTACT', 'email': 't.desmidt@chu-tours.fr', 'phone': '0234378952', 'phoneExt': '+33'}], 'facility': 'University hospital', 'geoPoint': {'lat': 47.39484, 'lon': 0.70398}}], 'centralContacts': [{'name': 'Thomas DESMIDT', 'role': 'CONTACT', 'email': 't.desmidt@chu-tours.fr', 'phone': '0234378952', 'phoneExt': '+33'}, {'name': 'Dominique BOMIA', 'role': 'CONTACT', 'email': 'd.bomia@chu-tours.fr', 'phone': '0247479785', 'phoneExt': '+33'}], 'overallOfficials': [{'name': 'Thomas DESMIDT', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Tours'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Tours', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}