How do Patients With Amnesia Acquire New Knowledge?

ConditionsAmnesia Memory Disorder

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18-70

SponsorUniversity Hospital, Toulouse

About this trial

THE STUDY AIMS to constitute the largest group of patients with major memory impairment resulting from various etiology and specific lesions of the medial temporal lobe (MTL) and use a combined psychometric and neuroimaging approach to study the factors allowing these patients to successfully learn new semantic information.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Patients aged between 18 and 70 years

Living in France since less than 20 years, being able to understand the French language, and have basic cultural knowledge as evaluated in classical clinical consultation

Written agreement to participate in the study

Intellectual capacities compatible with the cognitive tasks and signing of consent

Disqualifiers

Subjects under the age of 18 or over 70

Contraindications for MRI (examples: wearers of a pacemaker or cardiac defibrillator, implanted equipment activated by an electrical, magnetic or mechanical system, wearers of haemostatic clips for intracerebral aneurysms or carotid arteries, wearers of orthopedic implants, claustrophobic)

Refusal to be informed of an anomaly detected during the MRI

Trial design

Design model

Parallel

Treatments tested in this trial

MRI
Other intervention
structural and functional resting state MRI
Psychometric
Other intervention
2 cognitive research tasks of semantic learning and neuropsychological assessment

Treatment groups

150 Participants

are divided into 2 treatment groups

Group A: Learning abilities for Patients with an amnesic syndromeExperimental treatment 2 interventions

Group B: Healthy controlsActive comparator 2 interventions

Trial outcomes

Primary outcomes

Performance on Fast-Mapping semantic learning task

* MRI measures: Anatomical MRI (T1-weighted) images will be analyzed using voxel-based lesion-symptom mapping (VLSM, MATLAB toolbox). Voxels will be classified as "lesioned" or "non-lesioned" in gray and white matter. * Behavioral measures: Performance on fast-mapping tasks (recognition scores). Those measurements will be aggregated : VLSM will be used to generate statistical maps of significant differences in fast-mapping recognition scores between lesioned vs. non-lesioned voxels across the T1 MRI. This method allows the evaluation of statistical relationships between specific brain lesions and behavioral deficits without requiring patient grouping by lesion site or behavioral threshold. VLSM integrates permutation testing for robust statistical inference and can analyze both discrete and graded lesions. As voxels may be located in either cortical or white matter regions, the approach enables the investigation of disconnection syndromes in addition to cortical syndromes.

Time frame

Baseline

Secondary outcomes

Performance of semantic learning

The performance of semantic learning during social interactions will be compared to another condition without social interactions. A correlation between the time elapsed since the brain injury and the performance on semantic learning tasks will be assessed. The effect of the localisation of the lesions (hippocampal or extra-hippocampal) will be determined.

Time frame

Baseline

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Hospital, Toulouse

Lead sponsor

National Research Agency, France

Collaborator

Source ClinicalTrials.gov

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