Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Study of the Neural Basis of Analogical Reasoning (ANALOG)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02236832
Recruitment Status : Recruiting
First Posted : September 11, 2014
Last Update Posted : March 14, 2017
Sponsor:
Collaborator:
Fondation pour la Recherche Médicale
Information provided by (Responsible Party):
Institut National de la Santé Et de la Recherche Médicale, France

Brief Summary:
Frontal patients are impaired in categorisation and analogical reasoning tasks, and different functional imaging studies from our group have shown the involvement of the prefrontal cortex in categorisation and analogy tasks. The aim of this project is to test our hypotheses about the role of the prefrontal cortex in explicit and implicit categorisation and analogy tasks.

Condition or disease Intervention/treatment Phase
Frontotemporal Dementia Progressive Supranuclear Palsy Healthy Subjects Device: transcranial magnetic stimulation Other: MRI imaging Other: EEG recording Behavioral: Neuropsychological examination Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 225 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Organisation du Cortex préfrontal ventrolatéral Pour l'Analogie: Approche Bimodale Chez le Sujet Sain et Chez le Patient Ayant un Syndrome Frontal.
Study Start Date : February 2015
Estimated Primary Completion Date : February 2020
Estimated Study Completion Date : February 2021


Arm Intervention/treatment
Experimental: FTD (frontotemporal dementia) patients
fronto-temporal demential patients
Other: MRI imaging
Other: EEG recording
Behavioral: Neuropsychological examination
Experimental: PSP patients
progressive supra nuclear palsy patients
Other: MRI imaging
Other: EEG recording
Behavioral: Neuropsychological examination
Active Comparator: healthy controls
healthy control education matched, age matched and sex matched with PSP and FTD patients
Other: MRI imaging
Other: EEG recording
Behavioral: Neuropsychological examination
Experimental: healthy participants
healthy participants that will participate to the TMS study.
Device: transcranial magnetic stimulation
Other: MRI imaging
Other: EEG recording
Behavioral: Neuropsychological examination
Experimental: healthy young participants
Healthy participants will be included for an EEG study
Other: EEG recording
Behavioral: Neuropsychological examination



Primary Outcome Measures :
  1. Performance in the implicat task [ Time Frame: day of inclusion (one day) ]

    Reaction time and accuracy will be registered for this categorization task. This task will be used in patients with FTD and in healthy controls (n=60).

    Participants will come only once during one day ot the research centre.


  2. Performance in the Similitude task [ Time Frame: from inclusion to 4 months after inclusion ]

    Reaction time and accuracy will be recorded while healthy subjects perform this categorization task, after a session of rTMS or during on line TMS (n=40).

    Participants will come 3 to 5 times at the research centre in a maximum period of 4 months.



Secondary Outcome Measures :
  1. recording of EEG [ Time Frame: day of inclusion (one day) ]

    EEG will be recorded in patients with FTD and in healthy controls for an analysis of event related potentials.

    Participants will come only once during one day a the research centre.


  2. Analysis of MRI [ Time Frame: day of inclusion (one day) ]

    T1 MRI will be recorded for VBM analysis in patients with FTD and healthy controls.

    Participants will come only once during one day at the research centre




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   20 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Healthy subjects:

  • subject affiliated to national health insurance
  • informed consent signed
  • normal neurological examination
  • subject aged at least 20

Patients:

  • FTD or PSP diagnostic criteria filled
  • patient affiliated to national health insurance
  • informed consent signed

Exclusion Criteria:

  • Severe psychiatric symptomatology and psychotropic drug use
  • unability to understand or perform the cognitive tasks.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02236832


Locations
Layout table for location information
France
ICM (Institut du cerveau et de la Moelle épinière) Recruiting
Paris, France, 75013
Contact: béatrice garcin, MD    0157274160    beagarcin@msn.com   
Contact: Richard Levy, MD, PhD    0149282430      
Principal Investigator: Richard Levy, MD, PhD         
Sub-Investigator: Béatrice Garcin, MD         
Sponsors and Collaborators
Institut National de la Santé Et de la Recherche Médicale, France
Fondation pour la Recherche Médicale
Investigators
Layout table for investigator information
Principal Investigator: Richard Levy, MD, PhD Institut du Cerveau et de la Moelle épinière, Paris
Layout table for additonal information
Responsible Party: Institut National de la Santé Et de la Recherche Médicale, France
ClinicalTrials.gov Identifier: NCT02236832    
Other Study ID Numbers: C14-17'
140662B-31 ( Other Identifier: ANSM (Agence Nationale de Sécurité du Médicament) )
2014-A00649-38 ( Other Identifier: ANSM ID RCB )
First Posted: September 11, 2014    Key Record Dates
Last Update Posted: March 14, 2017
Last Verified: March 2017
Additional relevant MeSH terms:
Layout table for MeSH terms
Supranuclear Palsy, Progressive
Frontotemporal Dementia
Aphasia, Primary Progressive
Pick Disease of the Brain
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders
Basal Ganglia Diseases
Movement Disorders
Ophthalmoplegia
Ocular Motility Disorders
Cranial Nerve Diseases
Tauopathies
Neurodegenerative Diseases
Paralysis
Neurologic Manifestations
Eye Diseases
Signs and Symptoms
Frontotemporal Lobar Degeneration
TDP-43 Proteinopathies
Proteostasis Deficiencies
Metabolic Diseases
Aphasia
Speech Disorders
Language Disorders
Communication Disorders
Neurobehavioral Manifestations