ANALOG: Study of the Neural Basis of Analogical Reasoning

• Sponsor: Institut National de la Santé Et de la Recherche Médicale, France (Other)
• Overall Status: Completed
• CT.gov ID: NCT02236832
• Collaborator: Fondation pour la Recherche Médicale (Other)
• Enrollment: 130
• Location: 1
• Arms: 5
• Actual Duration (Months): 72
• Patients Per Site Per Month: 1.8

Study Details

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.

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	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 130 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.
• Actual Study Start Date: Feb 1, 2015
• Actual Primary Completion Date: Feb 1, 2021
• Actual Study Completion Date: Feb 1, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Performance in the implicat task [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 [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 [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 [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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 85 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	ICM (Institut du cerveau et de la Moelle épinière)	Paris		France	75013

Sponsors and Collaborators

• Institut National de la Santé Et de la Recherche Médicale, France
• Fondation pour la Recherche Médicale

Investigators

• Principal Investigator: Richard Levy, MD, PhD, Institut du Cerveau et de la Moelle épinière, Paris

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• 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; 2014-A00649-38
• First Posted: Sep 11, 2014
• Last Update Posted: Apr 1, 2022
• Last Verified: Mar 1, 2017

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Additional relevant MeSH terms: Supranuclear Palsy, Progressive; Frontotemporal Dementia; Aphasia, Primary Progressive; Pick Disease of the Brain

Study Results

No Results Posted as of Apr 1, 2022