Study of the Neural Basis of Analogical Reasoning (ANALOG)
Primary Purpose
Frontotemporal Dementia, Progressive Supranuclear Palsy, Healthy Subjects
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
transcranial magnetic stimulation
MRI imaging
EEG recording
Neuropsychological examination
Sponsored by
About this trial
This is an interventional basic science trial for Frontotemporal Dementia
Eligibility 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.
Sites / Locations
- ICM (Institut du cerveau et de la Moelle épinière)
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
Experimental
Experimental
Active Comparator
Experimental
Experimental
Arm Label
FTD (frontotemporal dementia) patients
PSP patients
healthy controls
healthy participants
healthy young participants
Arm Description
fronto-temporal demential patients
progressive supra nuclear palsy patients
healthy control education matched, age matched and sex matched with PSP and FTD patients
healthy participants that will participate to the TMS study.
Healthy participants will be included for an EEG study
Outcomes
Primary Outcome Measures
Performance in the implicat task
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.
Performance in the Similitude task
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
recording of EEG
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.
Analysis of MRI
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
Full Information
NCT ID
NCT02236832
First Posted
August 28, 2014
Last Updated
March 21, 2022
Sponsor
Institut National de la Santé Et de la Recherche Médicale, France
Collaborators
Fondation pour la Recherche Médicale
1. Study Identification
Unique Protocol Identification Number
NCT02236832
Brief Title
Study of the Neural Basis of Analogical Reasoning
Acronym
ANALOG
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 Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
February 2015 (Actual)
Primary Completion Date
February 2021 (Actual)
Study Completion Date
February 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut National de la Santé Et de la Recherche Médicale, France
Collaborators
Fondation pour la Recherche Médicale
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Frontotemporal Dementia, Progressive Supranuclear Palsy, Healthy Subjects
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
130 (Actual)
8. Arms, Groups, and Interventions
Arm Title
FTD (frontotemporal dementia) patients
Arm Type
Experimental
Arm Description
fronto-temporal demential patients
Arm Title
PSP patients
Arm Type
Experimental
Arm Description
progressive supra nuclear palsy patients
Arm Title
healthy controls
Arm Type
Active Comparator
Arm Description
healthy control education matched, age matched and sex matched with PSP and FTD patients
Arm Title
healthy participants
Arm Type
Experimental
Arm Description
healthy participants that will participate to the TMS study.
Arm Title
healthy young participants
Arm Type
Experimental
Arm Description
Healthy participants will be included for an EEG study
Intervention Type
Device
Intervention Name(s)
transcranial magnetic stimulation
Intervention Type
Other
Intervention Name(s)
MRI imaging
Intervention Type
Other
Intervention Name(s)
EEG recording
Intervention Type
Behavioral
Intervention Name(s)
Neuropsychological examination
Primary Outcome Measure Information:
Title
Performance in the implicat task
Description
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.
Time Frame
day of inclusion (one day)
Title
Performance in the Similitude task
Description
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.
Time Frame
from inclusion to 4 months after inclusion
Secondary Outcome Measure Information:
Title
recording of EEG
Description
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.
Time Frame
day of inclusion (one day)
Title
Analysis of MRI
Description
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
Time Frame
day of inclusion (one day)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard Levy, MD, PhD
Organizational Affiliation
Institut du Cerveau et de la Moelle épinière, Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
ICM (Institut du cerveau et de la Moelle épinière)
City
Paris
ZIP/Postal Code
75013
Country
France
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
IPD sharing will be only performed on individual request for a specified study.
Learn more about this trial
Study of the Neural Basis of Analogical Reasoning
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