NCT05943054

Brief Summary

Time processing is fundamental to survival and goal reaching in humans. Different time scales (seconds, minutes, and beyond) are processed through specific cognitive processes involving different neural representations. It is generally agreed that time scale in seconds-to-minutes range named "interval timing" would be anatomically linked to the striatum. Indeed, it is possible to demonstrate a deficit of interval timing processes in patients suffering from striatal damage (Huntington's disease). However, recent findings show involvement of a second brain structure, the hippocampus, in interval timing processing in the minutes range, suggesting an interaction between the striatum and hippocampus. Presumably, patients with hippocampal damage (Alzheimer's disease) would specifically show a decrease in performance for this minutes-range time scale. This study aims to provide a better understanding of the role of the striatum in the treatment of time and its interactions with other brain structures such as the hippocampus. More specifically, it is unclear whether the striatum plays a platform role that would always be involved regardless of the time scale, as suggested by the unified model of time or whether different brain structures is solicited according to the time scale, as suggested by the modular system model. In order to elucidate these issues, a potential double dissociation between brain structures and time scales will be tested.

Trial Health

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Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
104

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

March 4, 2022

Completed
10 months until next milestone

Study Start

First participant enrolled

January 6, 2023

Completed
6 months until next milestone

First Posted

Study publicly available on registry

July 12, 2023

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2025

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2026

Completed
Last Updated

July 12, 2023

Status Verified

July 1, 2023

Enrollment Period

2.2 years

First QC Date

March 4, 2022

Last Update Submit

July 5, 2023

Conditions

Keywords

Time processingHuntington's diseaseAlzheimer's diseaseStriatumHippocampus

Outcome Measures

Primary Outcomes (1)

  • Ability to discriminate durations

    Ability to discriminate durations of a few seconds and durations of the order of minutes

    25 months and 10 days

Secondary Outcomes (2)

  • Risks's prediction of temporal disorientation.

    26 months

  • Identification of neural correlations with temporal perception tests

    27 months

Study Arms (3)

Patients carrying the Huntington's gene

EXPERIMENTAL

A "long" temporal perception task and a "short" temporal perception task

Other: Temporal perception tasks

Alzheimer's disease patients

EXPERIMENTAL

A "long" temporal perception task and a "short" temporal perception task

Other: Temporal perception tasks

Healthy Volunteers

ACTIVE COMPARATOR

A "long" temporal perception task and a "short" temporal perception task

Other: Temporal perception tasks

Interventions

A "long" temporal perception task in which the duration of the stimulus, around 2 min, is materialized by a video. For each trial, two videos are displayed to the participants, and then the task of the participant is to indicate the longest video and to give his level of confidence in his answer. A "short" temporal perception task which will take place in the same way as the "long" task except that the duration of the stimulus, around 2 seconds, is materialized by still frames from the videos used in the previous task.

Alzheimer's disease patientsHealthy VolunteersPatients carrying the Huntington's gene

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Huntington's disease gene carriers
  • Patient included in the BioHD protocol
  • Age from 18 to 90 years old
  • Symptomatic patient
  • TFC ≥ 11
  • UHDRS motor\> 5
  • Native language: French
  • Affiliation to a social security or to another social protection
  • Signature of informed consent
  • Patients with Alzheimer's disease
  • MMS from 20 to 26 (included)
  • Age: from 60 to 90 years old
  • Native language: French
  • Progressive deterioration of memory reported by patient or caregiver for more than 6 months
  • Profile at RL /RI 16: no significant improvement with indexing
  • +11 more criteria

You may not qualify if:

  • Huntington's disease gene carriers
  • Intellectual deterioration preventing understanding of the protocol
  • Other dementia than Huntington's disease
  • Patient living alone at home
  • Major depression
  • Patient under legal protection
  • Patient deprived of liberty
  • Pregnant or breastfeeding woman, situation known to the investigator
  • Inability to handle an electronic tablet
  • Patients with Alzheimer's disease
  • Intellectual deterioration preventing understanding of the protocol
  • Patient living alone at home
  • Sudden onset of memory impairment
  • Early onset of the following symptoms: difficulty in walking, convulsions, changes in behavior
  • Focal neurological characteristics including hemiparesis, sensory loss, visual field deficit
  • +16 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assistance Publique Hôpitaux de Paris - Hôpital Henri Mondor

Créteil, 94010, France

RECRUITING

MeSH Terms

Conditions

Huntington DiseaseAlzheimer Disease

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 DisordersTauopathies

Study Officials

  • Anne-Catherine BACHOUD-LEVI, MD, PhD

    Assistance Publique - Hôpitaux de Paris

    STUDY DIRECTOR

Central Study Contacts

Anne-Catherine BACHOUD-LEVI, MD, PhD

CONTACT

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

March 4, 2022

First Posted

July 12, 2023

Study Start

January 6, 2023

Primary Completion

March 30, 2025

Study Completion

March 30, 2026

Last Updated

July 12, 2023

Record last verified: 2023-07

Locations