NCT07191197

Brief Summary

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
46mo left

Started Jan 2026

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress8%
Jan 2026Jan 2030

First Submitted

Initial submission to the registry

August 25, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

September 24, 2025

Completed
3 months until next milestone

Study Start

First participant enrolled

January 1, 2026

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2030

Last Updated

December 16, 2025

Status Verified

December 1, 2025

Enrollment Period

4.1 years

First QC Date

August 25, 2025

Last Update Submit

December 15, 2025

Conditions

Keywords

LearningSemantic memoryHippocampusTemporal pole

Outcome Measures

Primary Outcomes (1)

  • 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.

    Baseline

Secondary Outcomes (1)

  • Performance of semantic learning

    Baseline

Study Arms (2)

Learning abilities for Patients with an amnesic syndrome

EXPERIMENTAL

1 MRI session, 2 cognitive research tasks of semantic learning, and neuropsychological assessment.

Other: MRIOther: Psychometric

Healthy controls

ACTIVE COMPARATOR

To allow multiple pairing for each patient, a group of 120 healthy controls aged between 18 to 70 years old will be recruited. Thus, it will be possible to compare one given patient to a group of 40 aged-matched subjects. All healthy volunteers will undergo the same intervention as the patients : 1 MRI session, 2 cognitive research tasks of semantic learning, neuropsychological assessment.

Other: MRIOther: Psychometric

Interventions

2 cognitive research tasks of semantic learning and neuropsychological assessment

Healthy controlsLearning abilities for Patients with an amnesic syndrome
MRIOTHER

structural and functional resting state MRI

Healthy controlsLearning abilities for Patients with an amnesic syndrome

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • Affiliation to the French social security system
  • For patients: bilateral brain lesion of the medial temporal lobe or the extended hippocampal system

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University Hospital of Caen

Caen, France

Location

University Hospital of Toulouse

Toulouse, France

Location

MeSH Terms

Conditions

AmnesiaMemory Disorders

Interventions

Psychometrics

Condition Hierarchy (Ancestors)

Neurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Psychological TestsBehavioral Disciplines and Activities

Central Study Contacts

Jérémie PARIENTE, MD + PHD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: sectional, experimental, comparative, bicentric study.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 25, 2025

First Posted

September 24, 2025

Study Start

January 1, 2026

Primary Completion (Estimated)

January 31, 2030

Study Completion (Estimated)

January 31, 2030

Last Updated

December 16, 2025

Record last verified: 2025-12

Locations