- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02236832
Study of the Neural Basis of Analogical Reasoning (ANALOG)
Organisation du Cortex préfrontal ventrolatéral Pour l'Analogie: Approche Bimodale Chez le Sujet Sain et Chez le Patient Ayant un Syndrome Frontal.
Study Overview
Status
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Paris, France, 75013
- ICM (Institut du cerveau et de la Moelle épinière)
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Non-Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: FTD (frontotemporal dementia) patients
fronto-temporal demential patients
|
|
Experimental: PSP patients
progressive supra nuclear palsy patients
|
|
Active Comparator: healthy controls
healthy control education matched, age matched and sex matched with PSP and FTD patients
|
|
Experimental: healthy participants
healthy participants that will participate to the TMS study.
|
|
Experimental: healthy young participants
Healthy participants will be included for an EEG study
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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. |
day of inclusion (one day)
|
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. |
from inclusion to 4 months after inclusion
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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. |
day of inclusion (one day)
|
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 |
day of inclusion (one day)
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Richard Levy, MD, PhD, Institut du Cerveau et de la Moelle épinière, Paris
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Metabolic Diseases
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Eye Diseases
- Neurologic Manifestations
- Neurobehavioral Manifestations
- Neurocognitive Disorders
- Basal Ganglia Diseases
- Movement Disorders
- Neurodegenerative Diseases
- TDP-43 Proteinopathies
- Proteostasis Deficiencies
- Dementia
- Tauopathies
- Cranial Nerve Diseases
- Ocular Motility Disorders
- Language Disorders
- Communication Disorders
- Paralysis
- Speech Disorders
- Frontotemporal Lobar Degeneration
- Ophthalmoplegia
- Aphasia
- Frontotemporal Dementia
- Aphasia, Primary Progressive
- Pick Disease of the Brain
- Supranuclear Palsy, Progressive
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)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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