Huntington Diseasee-TimeNCT05943054
Striatum and Hippocampus on Different Time Scales
A study testing Temporal perception tasks in people with Huntington Disease and Alzheimer Disease, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Huntington Disease, Alzheimer Disease
- What is being tested?
- Temporal perception tasks
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 siteFrance
- Study dates
- 6 Jan 2023to 30 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
Anne-Catherine BACHOUD-LEVI, MD, PhD contact
France1 site, 1 recruiting
- Recruiting
Assistance Publique Hôpitaux de Paris - Hôpital Henri Mondor
Créteil, 94010
Anne-Catherine BACHOUD-LEVI, MD,PHD, 01 49 81 23 10 ext. +33, anne-catherine.bachoud-levi@aphp.fr
About this study
Official title: Role of the Striatum and Hippocampus on Different Time Scales
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.
Read the 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.
- Conditions
- Huntington Disease, Alzheimer Disease
- Being tested
- Temporal perception tasks
- Keywords
- Time processing, Huntington's disease, Alzheimer's disease, Striatum, Hippocampus
- Medical subject headings
- Huntington Disease, Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Temporal perception tasksOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Patients carrying the Huntington's gene | Experimental | A "long" temporal perception task and a "short" temporal perception task Receives: Other: Temporal perception tasks |
| Alzheimer's disease patients | Experimental | A "long" temporal perception task and a "short" temporal perception task Receives: Other: Temporal perception tasks |
| Healthy Volunteers | Active comparator | A "long" temporal perception task and a "short" temporal perception task Receives: Other: Temporal perception tasks |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ability to discriminate durations
Ability to discriminate durations of a few seconds and durations of the order of minutes
Measured: 25 months and 10 days
Secondary outcomes (2)
Risks's prediction of temporal disorientation.
Analysis of the answers (true/false) to the questionnaire assessing temporal orientation in daily life
Measured: 26 months
Identification of neural correlations with temporal perception tests
Brain magnetic resonance imaging analysis
Measured: 27 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2023
- Study start6 Jan 2023
- Primary completion30 Mar 2025 (estimated)
- Study completion30 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Huntington DiseaseStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- 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
- Masking
- None (open label)
- Enrolment
- 104 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anne-Catherine BACHOUD-LEVI, MD, PhD, Study director, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05943054
- Sponsor's protocol ID
- APHP20211105
- Other IDs
- 2021-A01008-33
- Acronym
- e-Time
- Status last verified
- Jul 2023
- First submitted
- 4 Mar 2022
- Last updated
- 12 Jul 2023
- 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 12 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of the Striatum and Hippocampus on Different Time Scales
- ClinicalTrials.gov ID
- NCT05943054
- Acronym / sponsor ID
- e-Time / APHP20211105
- Conditions
- Huntington Disease, Alzheimer Disease
- Keywords
- Time processing, Huntington's disease, Alzheimer's disease, Striatum, Hippocampus
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 104 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 6 Jan 2023 (actual)
- Primary completion
- 30 Mar 2025 (estimated)
- Study completion
- 30 Mar 2026 (estimated)
- First posted
- 12 Jul 2023 (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.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Patients carrying the Huntington's gene | Experimental | Other: Temporal perception tasksA "long" temporal perception task and a "short" temporal perception task |
| Alzheimer's disease patients | Experimental | Other: Temporal perception tasksA "long" temporal perception task and a "short" temporal perception task |
| Healthy Volunteers | Active comparator | Other: Temporal perception tasksA "long" temporal perception task and a "short" temporal perception task |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (26 listed)
- Huntington's disease gene carriers
Key exclusion criteria (31 listed)
- Huntington's disease gene carriers
- Patients with Alzheimer's disease
- Healthy subjects
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 |
|---|---|---|
| Temporal perception tasksA "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. | Other | Alzheimer's disease patients, Healthy Volunteers, Patients carrying the Huntington's gene |
Primary outcome
Ability to discriminate durations
Time frame: 25 months and 10 days
Ability to discriminate durations of a few seconds and durations of the order of minutes
2 secondary outcomes
Risks's prediction of temporal disorientation.
Time frame: 26 months
Identification of neural correlations with temporal perception tests
Time frame: 27 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2023.
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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. This study is not recruiting at the moment.
Anne-Catherine BACHOUD-LEVI, MD, PhD contact
Anne-Catherine BACHOUD-LEVI, MD, PhD study director
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Temporal perception tasks in people with Huntington Disease and Alzheimer Disease, run by Assistance Publique - Hôpitaux de Paris at 1 site 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 26 inclusion and 31 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: status not confirmed, as of the sponsor's last update on 12 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anne-Catherine BACHOUD-LEVI, MD, PhD (01 49 81 23 10 ext. +33, anne-catherine.bachoud-levi@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ability to discriminate durations (time frame: 25 months and 10 days). 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 12 Jul 2023; AzTrials last refreshed its copy on 2 Nov 2026.