AmnesiaASSAMNCT07191197
How do Patients With Amnesia Acquire New Knowledge?
A study testing MRI and Psychometric in people with Amnesia and Memory Disorder, run by University Hospital, Toulouse at 2 sites in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Amnesia, Memory Disorder
- What is being tested?
- MRI and Psychometric
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 2 sitesFrance
- Study dates
- 8 Apr 2026to 31 Jan 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France2 sites, 1 recruiting
- Active, not recruiting
University Hospital of Caen
Caen
- Recruiting
University Hospital of Toulouse
Toulouse
Jérémie PARIENTE, MD + PHD, 05 61 77 94 88, pariente.j@chu-toulouse.fr
Clémence Le Bervet, MASTER, 0561777087, drci.toulouse@chu-toulouse.fr
About this study
Official title: New Semantic Learning in Patients With Selective Brain Lesions in Temporal Regions: a Behavioural and MRI Study
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.
Read the detailed description
The preservation of learning abilities is an essential aspect in the implementation of cognitive rehabilitation programs for patients with an amnesic syndrome. Particularly disabled on a daily basis, these patients have significant difficulties in coping with the demands of work and family life. Data from previous case studies attest to the ability of these patients to rely on preserved cognitive systems to learn new semantic information. However, the procedures for the acquisition of new information are sometimes long, not optimal and the clinical factors, that can influence it, are poorly identified. In addition, the brain networks necessary for such learning are still debated. In order to better understand the cognitive mechanisms and brain networks that underlie the ability to learn new semantic information, the research aims to study a group of patients with major memory impairment following medial temporal lobe lesions of various etiologies (non-degenerative). The study will use a combined psychometric and neuroimaging approach to identify the factors that enable these patients to successfully learn new semantic information.
- Conditions
- Amnesia, Memory Disorder
- Being tested
- MRI, Psychometric
- Keywords
- Learning, Semantic memory, Hippocampus, Temporal pole
- Medical subject headings
- Amnesia, Memory Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRIOther
structural and functional resting state MRI
PsychometricOther
2 cognitive research tasks of semantic learning and neuropsychological assessment
| Study group | Role | What they receive |
|---|---|---|
| Learning abilities for Patients with an amnesic syndrome | Experimental | 1 MRI session, 2 cognitive research tasks of semantic learning, and neuropsychological assessment. Receives: Other: MRI; Other: 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. Receives: Other: MRI; Other: Psychometric |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline
Secondary outcomes (1)
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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2025
- Study start8 Apr 2026
- Primary completion31 Jan 2030 (estimated)
- Study completion31 Jan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AmnesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- sectional, experimental, comparative, bicentric study.
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Collaborators
- National Research Agency, France
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07191197
- Sponsor's protocol ID
- RC31/23/0377
- Acronym
- ASSAM
- Status last verified
- May 2026
- First submitted
- 25 Aug 2025
- Last updated
- 8 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- New Semantic Learning in Patients With Selective Brain Lesions in Temporal Regions: a Behavioural and MRI Study
- ClinicalTrials.gov ID
- NCT07191197
- Acronym / sponsor ID
- ASSAM / RC31/23/0377
- Conditions
- Amnesia, Memory Disorder
- Keywords
- Learning, Semantic memory, Hippocampus, Temporal pole
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Collaborators
- National Research Agency, France
- Study start
- 8 Apr 2026 (actual)
- Primary completion
- 31 Jan 2030 (estimated)
- Study completion
- 31 Jan 2030 (estimated)
- First posted
- 24 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The preservation of learning abilities is an essential aspect in the implementation of cognitive rehabilitation programs for patients with an amnesic syndrome. Particularly disabled on a daily basis, these patients have significant difficulties in coping with the demands of work and family life. Data from previous case studies attest to the ability of these patients to rely on preserved cognitive systems to learn new semantic information. However, the procedures for the acquisition of new information are sometimes long, not optimal and the clinical factors, that can influence it, are poorly identified. In addition, the brain networks necessary for such learning are still debated. In order to better understand the cognitive mechanisms and brain networks that underlie the ability to learn new semantic information, the research aims to study a group of patients with major memory impairment following medial temporal lobe lesions of various etiologies (non-degenerative). The study will use a combined psychometric and neuroimaging approach to identify the factors that enable these patients to successfully learn new semantic information.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- sectional, experimental, comparative, bicentric study.
| Arm | Type | Receives |
|---|---|---|
| Learning abilities for Patients with an amnesic syndrome | Experimental | Other: MRI, Other: Psychometric1 MRI session, 2 cognitive research tasks of semantic learning, and neuropsychological assessment. |
| Healthy controls | Active comparator | Other: MRI, Other: PsychometricTo 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRIstructural and functional resting state MRI | Other | Healthy controls, Learning abilities for Patients with an amnesic syndrome |
| Psychometric2 cognitive research tasks of semantic learning and neuropsychological assessment | Other | Healthy controls, Learning abilities for Patients with an amnesic syndrome |
Primary outcome
Performance on Fast-Mapping semantic learning task
Time frame: Baseline
* 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.
1 secondary outcome
Performance of semantic learning
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MRI and Psychometric in people with Amnesia and Memory Disorder, run by University Hospital, Toulouse at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jérémie PARIENTE, MD + PHD (05 61 77 94 88, pariente.j@chu-toulouse.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Performance on Fast-Mapping semantic learning task (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2026.