How do Patients With Amnesia Acquire New Knowledge?
ASSAM
New Semantic Learning in Patients With Selective Brain Lesions in Temporal Regions: a Behavioural and MRI Study
1 other identifier
interventional
150
1 country
2
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2026
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 25, 2025
CompletedFirst Posted
Study publicly available on registry
September 24, 2025
CompletedStudy Start
First participant enrolled
January 1, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 31, 2030
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 31, 2030
December 16, 2025
December 1, 2025
4.1 years
August 25, 2025
December 15, 2025
Conditions
Keywords
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
EXPERIMENTAL1 MRI session, 2 cognitive research tasks of semantic learning, and neuropsychological assessment.
Healthy controls
ACTIVE COMPARATORTo 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.
Interventions
2 cognitive research tasks of semantic learning and neuropsychological assessment
structural and functional resting state MRI
Eligibility Criteria
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
- University Hospital, Toulouselead
- National Research Agency, Francecollaborator
Study Sites (2)
University Hospital of Caen
Caen, France
University Hospital of Toulouse
Toulouse, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- 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