NCT07409597

Brief Summary

Huntington's disease (HD) is a hereditary neurodegenerative disorder characterized by progressively worsening motor, cognitive, psychiatric, and behavioral deficits. Cognitive deficits occur early on, affecting in particular executive functions (inhibition, flexibility), decision-making, memory, attention (selective, sustained), perceptual and visuospatial skills, and information processing speed. More specifically, memory deficits quickly affect different memory systems (short-term memory, long-term memory, etc.), including autobiographical memory. Autobiographical memory is usually defined as a system that stores all the information (semantic component) and specific memories (episodic component) specific to an individual, accumulated from an early age. Autobiographical memory is now considered essential to the construction of a sense of identity and continuity. It is also considered indispensable for projecting into the future, otherwise known as "episodic future thinking," a fundamental human capacity that is both anticipatory and adaptive. Autobiographical memory deficits remain largely unexplored in HD, with only three studies identified in the international literature on the subject, one of which is actually based on the same neuropsychological data as another, adding a neuroanatomical analysis focused on autobiographical memory. These studies show that the autobiographical recollections of patients with HD are mainly descriptive recollections of personal events lacking in detail, and that the abnormalities appear to be linked to the progressive degeneration of a vast cortico-subcortical brain network comprising the medial temporal cortex, the frontal cortex, and the posterior striatal and parietal regions. Deficits in episodic future thinking have never been explored in HD. A better understanding of the mechanisms underlying this type of cognitive impairment (recalling personal memories and mentally simulating future personal events) remains a major challenge today in improving the care of patients with HD. Several recent studies have shown, in different pathological contexts (Alzheimer's disease, etc.), that the parallel use of neuropsychological tests (tasks and questionnaires) and an eye-tracking system allows for a much more accurate and in-depth examination of cognitive functions (for a review, see). In addition, eye movements, such as fixations and saccades, have been associated with the retrieval of autobiographical events . These movements better reflected the person's subjective experience, particularly with regard to the visual elements of mental imagery of recovered events. This suggests that the analysis of eye behavior could enrich the assessment of autobiographical memory, beyond the data provided by traditional tests. The examination of eye movements is therefore, alongside neuropsychological testing, a promising non-invasive method for better understanding the characteristics of autobiographical memory in HD. This project therefore aims to explore the autobiographical memory of HD patients by analyzing their eye activity during tasks involving the recall of personal events using standard neuropsychological tools. By identifying oculomotor markers associated with autobiographical memory disorders, this research could: (1) provide a better understanding of the neurocognitive profile of HD, (2) pave the way for more accurate diagnostic tools, and (3) form an important basis for the development of future interventions aimed at supporting memory function in this population.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
33mo left

Started Apr 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

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 Progress11%
Apr 2026Apr 2029

First Submitted

Initial submission to the registry

February 3, 2026

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 13, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

April 1, 2026

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2029

Last Updated

February 13, 2026

Status Verified

February 1, 2026

Enrollment Period

3 years

First QC Date

February 3, 2026

Last Update Submit

February 12, 2026

Conditions

Outcome Measures

Primary Outcomes (5)

  • Assess the recall of personal memories and mental simulation of future personal events in patients with genetically confirmed HD, through analysis of the specificity

    It will be assessed using the TEMPau specificity scale. This scale uses a Likert scale ranging from 0 to 4 points (0: no response or general information; 1: vague event without spatial-temporal context; 2: generic or specific event without spatial-temporal context; 3: specific event in a non-detailed spatial-temporal context; 4: specific event in a detailed spatial-temporal context). This scale allows two main scores to be collected for each period of life explored: 1) an overall autobiographical memory score counting all events, regardless of their nature (max.: 3 x 1 = 3) and 2) a strictly episodic score, counting only memories that meet all the criteria for episodicity, rated 4 (max.: 3 x 4 = 12). The scale also provides: 1) an overall autobiographical memory score for all four life periods explored (max.: 3 x 4 = 12) and an overall strictly episodic score, counting only memories that meet all the criteria for episodicity across all four periods, rated 4 (max.: 12 x 4 = 48).

    inclusion

  • Assess the recall of personal memories and mental simulation of future personal events in patients with genetically confirmed HD through analysis of the phenomenology

    self-questionnaire comprising eight items, measured on a Likert scale ranging from 1 to 4 points (1: no, that is completely untrue; 2: no, that is rather untrue; 3: yes, that is rather true; 4: yes, that is completely true). The 8 items are as follows: 1: I felt like I was reliving the original event; 2: I felt like I was travelling back in time to the moment when the event happened; 3: I don't just know that this event happened, I remember actually experiencing it; 4: I believe that the event in my memory actually happened as I remember it; 5: I can see and hear elements of the event in my mind; 6: I can now feel the emotions I felt when the event happened; 7: I can remember where the event took place; I can remember the time when the event occurred. This scale allows a phenomenological score to be obtained for each period of life explored (max.: 3 x 8 x 4 = 96) and an overall phenomenological score for all four periods of life explored (max.: 3 x 8 x 4 x 4 = 380).

    inclusion

  • Assess the recall of personal memories and mental simulation of future personal events in patients with genetically confirmed HD through analysis of the self-defined nature

    Each memory is evaluated according to six empirically based dimensions: 1. the specificity of the event (rated from 0 to 4 according to TEMPau criteria, with 0 = extended or semantic memory, 4 = unique event, situated in time and space), 2. identity relevance ('This memory reflects an important part of who I am') 3. the presence of a lasting personal conflict or theme ('This memory is linked to an important theme or conflict in my life') 4. emotional intensity ('This memory expresses a very strong or striking emotion') 5. reflective integration ('This memory has helped me learn a personal lesson') 6. frequency of mental access ('This is a memory I often think back on or talk about regularly') The last five dimensions are assessed by self-questionnaire, on a Likert scale ranging from 1 to 4 (1 = not at all, 4 = completely). This combination gives an overall SDM score ranging from 5 (weakly self-defined memory) to 24.

    inclusion

  • Assess the recall of personal memories and mental simulation of future personal events in patients with genetically confirmed HD through analysis of the emotional valence

    It will be assessed using the 'Then' and 'Now' scale, which consists of asking the subject to evaluate (self-questionnaire), for each memory, on a Likert scale ranging from -3 to 3, how they felt at the time the event occurred and how they feel when they recall it.

    inclusion

  • Assess the recall of personal memories and mental simulation of future personal events in patients with genetically confirmed HD through analysis of the degree of integration of memories

    It will be assessed qualitatively using the definitions provided by Blagov and Singer (2004): * Integrative memories: There is a shift away from narrative events and descriptions to make an additional statement about the importance or significance of the memory to the individual. A meaningful statement must go beyond simply saying that the memory is 'important', 'the most painful' or 'a memory I will never forget'. There must be an indication of why the memory is important and moving. * Non-integrative memories: These are discussed in the manual and do not meet the requirements of integrative memories.

    inclusion

Secondary Outcomes (11)

  • To study the variation in pupil dilation characteristics during the recall of autobiographical memories.

    inclusion

  • To study the variation of eye movements during the recall of autobiographical memories (number).

    inclusion

  • To study the variation of eye movements during the recall of autobiographical memories (duration).

    inclusion

  • Study the links between participants' temporal perspective (past, present, future)and their autobiographical performance

    inclusion

  • analyse the current representation of the self (psychological, social, physical)

    inclusion

  • +6 more secondary outcomes

Study Arms (2)

healthy patients

ACTIVE COMPARATOR
Other: neuropsychological testsOther: Eye tracker use

patients with Huntington's disease

ACTIVE COMPARATOR
Other: neuropsychological testsOther: Eye tracker use

Interventions

different neuropsycholocical tests

healthy patientspatients with Huntington's disease

Eye movement assessment/recording is performed under two conditions: a "control" condition and an "autobiographical recall" condition.

healthy patientspatients with Huntington's disease

Eligibility Criteria

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

You may qualify if:

  • For patients:
  • Huntington's disease diagnosed and confirmed by genetic analysis
  • Patients in the presymptomatic stage of HD with a motor UHDRS score ≤ 5 and patients in symptomatic stages 1-2 of HD with a motor UHDRS score \> 5 and a CFT between 6 \< CFT ≤ 13
  • Patients who have given their written informed consent or consent from a third party
  • Affiliated with or beneficiary of a social security system
  • For healthy controls:
  • Individuals with no history of neurological disorders (interview and clinical examination)
  • Signature of informed consent to participate in the study
  • Affiliated with or beneficiary of a social security system
  • Matching in age (± 5 years), sex, and level of education with an HD patient included in the control group
  • MMSE ≥ 24/30

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Angers

Angers, 49933, France

Location

MeSH Terms

Conditions

Huntington Disease

Interventions

Neuropsychological Tests

Condition Hierarchy (Ancestors)

Basal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesDementiaChoreaDyskinesiasMovement DisordersHeredodegenerative Disorders, Nervous SystemNeurodegenerative DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesCognition DisordersNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Psychological TestsBehavioral Disciplines and Activities

Central Study Contacts

Philippe ALLAIN, Professor

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 3, 2026

First Posted

February 13, 2026

Study Start

April 1, 2026

Primary Completion (Estimated)

April 1, 2029

Study Completion (Estimated)

April 1, 2029

Last Updated

February 13, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will share

Data will be shared upon reasonable request. Only de-identified data will be shared. Any data collected during the study may be shared. The protocol will be shared initially. Other documents may be shared at a later date upon request (e.g., the CRF to allow a collaborator to select the data they wish to access). The recipients of the data will be researchers. The data will be available for any purpose deemed relevant by the study investigator, based on a protocol provided by the requester, after verification of the obtaining of regulatory approvals, including the favorable opinion of an ethics committee.

Shared Documents
STUDY PROTOCOL
Time Frame
The data will be shared after signing a negotiated data transfer agreement ( data access agreement), for the duration specified in the agreement.
Access Criteria
The data will be made available via secure transfer (sharing platform approved by the university hospital: BlueFiles or Oodrive).

Locations