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Striatum and Hippocampus on Different Time Scales (e-Time)

Primary Purpose

Huntington Disease, Alzheimer Disease

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Temporal perception tasks
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Huntington Disease focused on measuring Time processing, Huntington's disease, Alzheimer's disease, Striatum, Hippocampus

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: 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 Episodic memory disorder isolated or associated with other cognitive disorders MRI: Atrophy of the median temporal lobe Affiliation to a social security or to another social protection Signature of informed consent • Healthy subjects Healthy subject included in the BioHD protocol MMS ≥ 26 Age from 18 to 90 years old Native language: French Affiliation to a social security or to another social protection Signature of informed consent Exclusion Criteria: 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 Early extrapyramidal sign Other dementia than Alzheimer's disease Major depression Cerebrovascular disease Toxic, metabolic or infectious anomaly Patient under legal protection Patient deprived of liberty Pregnant or breastfeeding woman, situation known to the investigator Inability to handle an electronic tablet Healthy subjects Intellectual deterioration preventing understanding of the protocol Known neurological or psychiatric illness Patient under legal protection Subject deprived of liberty Pregnant or breastfeeding woman, situation known to the investigator Inability to handle an electronic tablet

Sites / Locations

  • Assistance Publique Hôpitaux de Paris - Hôpital Henri MondorRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Patients carrying the Huntington's gene

Alzheimer's disease patients

Healthy Volunteers

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Risks's prediction of temporal disorientation.
Analysis of the answers (true/false) to the questionnaire assessing temporal orientation in daily life
Identification of neural correlations with temporal perception tests
Brain magnetic resonance imaging analysis

Full Information

First Posted
March 4, 2022
Last Updated
July 5, 2023
Sponsor
Assistance Publique - Hôpitaux de Paris
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1. Study Identification

Unique Protocol Identification Number
NCT05943054
Brief Title
Striatum and Hippocampus on Different Time Scales
Acronym
e-Time
Official Title
Role of the Striatum and Hippocampus on Different Time Scales
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 6, 2023 (Actual)
Primary Completion Date
March 30, 2025 (Anticipated)
Study Completion Date
March 30, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
In that aim, we will evaluate patients with Huntington's disease and patients with Alzheimer's disease by developing and using time processing paradigms comparing short and long time scales.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Huntington Disease, Alzheimer Disease
Keywords
Time processing, Huntington's disease, Alzheimer's disease, Striatum, Hippocampus

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
104 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Patients carrying the Huntington's gene
Arm Type
Experimental
Arm Description
A "long" temporal perception task and a "short" temporal perception task
Arm Title
Alzheimer's disease patients
Arm Type
Experimental
Arm Description
A "long" temporal perception task and a "short" temporal perception task
Arm Title
Healthy Volunteers
Arm Type
Active Comparator
Arm Description
A "long" temporal perception task and a "short" temporal perception task
Intervention Type
Other
Intervention Name(s)
Temporal perception tasks
Intervention Description
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.
Primary Outcome Measure Information:
Title
Ability to discriminate durations
Description
Ability to discriminate durations of a few seconds and durations of the order of minutes
Time Frame
25 months and 10 days
Secondary Outcome Measure Information:
Title
Risks's prediction of temporal disorientation.
Description
Analysis of the answers (true/false) to the questionnaire assessing temporal orientation in daily life
Time Frame
26 months
Title
Identification of neural correlations with temporal perception tests
Description
Brain magnetic resonance imaging analysis
Time Frame
27 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Episodic memory disorder isolated or associated with other cognitive disorders MRI: Atrophy of the median temporal lobe Affiliation to a social security or to another social protection Signature of informed consent • Healthy subjects Healthy subject included in the BioHD protocol MMS ≥ 26 Age from 18 to 90 years old Native language: French Affiliation to a social security or to another social protection Signature of informed consent Exclusion Criteria: 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 Early extrapyramidal sign Other dementia than Alzheimer's disease Major depression Cerebrovascular disease Toxic, metabolic or infectious anomaly Patient under legal protection Patient deprived of liberty Pregnant or breastfeeding woman, situation known to the investigator Inability to handle an electronic tablet Healthy subjects Intellectual deterioration preventing understanding of the protocol Known neurological or psychiatric illness Patient under legal protection Subject deprived of liberty Pregnant or breastfeeding woman, situation known to the investigator Inability to handle an electronic tablet
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anne-Catherine BACHOUD-LEVI, MD, PhD
Phone
01 49 81 23 10
Ext
+33
Email
anne-catherine.bachoud-levi@aphp.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Laurie LEMOINE
Phone
01 49 81 21 11
Ext
+33
Email
laurie.lemoine@aphp.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anne-Catherine BACHOUD-LEVI, MD, PhD
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Study Director
Facility Information:
Facility Name
Assistance Publique Hôpitaux de Paris - Hôpital Henri Mondor
City
Créteil
ZIP/Postal Code
94010
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anne-Catherine BACHOUD-LEVI, MD,PHD
Phone
01 49 81 23 10
Ext
+33
Email
anne-catherine.bachoud-levi@aphp.fr

12. IPD Sharing Statement

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Striatum and Hippocampus on Different Time Scales

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