Neurocognitive DisordersINSPENCT04240405
Effects of Episodic Specificity Induction in Normal and Pathological Ageing.
An observational study of Neurocognitive Disorders, run by Hospices Civils de Lyon at 2 sites in France.
Trial summary
Episodic Specificity Induction (ESI) is a short training that improves the production of episodic details during autobiographical recall in young and elderly people without cognitive impairment. Read more about this study
- Who is it for?
- Ages 55 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Neurocognitive Disorders
- How many people
- 42 participants
- Where
- 2 sitesFrance
- Study dates
- 11 Dec 2019to 19 Apr 2024
- Phase
- Observational
- 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 55 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: This study looks at a population of adults between the ages of 55 and 85 and 3 types of sample of subjects extracted from this population : 1. 24 elderly people without cognitive impairment 2. 24 amnestic type mild cognitive impairment patients (aMCI) 3. 24 dysexecutive type mild cognitive impairment patients (dMCI)
Who may be able to join
- The participant:
- has provided informed consent obtained in accordance with Good Clinical Practices.
- is affiliated to a social security system.
- speaks fluent French.
- is between 55 and 85 years of age.
- For the participants of the control group:
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- has a Montreal Cognitive Assessment (MoCA) score equal to or greater than 26;
- has neuropsychological assessment performance (RL/RI 16, D080, TMT, VOSP, Rey's figure) in the norm according to his socio-professional category and age, i.e. less than two deviating scores of -1 standard deviation or less than the 10th percentile per function.
- For patients in the TCLa group:
- has at least two scores below the 10th percentile or below -1 standard deviation from the norm on neuropsychological assessment tests that assess memory, based on its socio-professional category and age;
- has less than two scores below the 10th percentile or less than -1 standard deviation from the norm in neuropsychological assessment tests that assess other functions. This is in accordance with the diagnostic criteria of Petersen (2004) and Jak and Bondi (2009).
- For patients in the TCLd group:
- has focal executive dysfunction expressed by at least two scores less than the 10th percentile or less than -1 standard deviation from the norm in neuropsychological assessment tests that assess executive functions (TMT, Stroop, verbal fluences, free recall in memory), according to his socio-professional category and age;
- has less than two scores below the 10th percentile or less than -1 standard deviation from the norm on neuropsychological assessment tests that assess other functions (except for free memory reminders and language fluences). This is in accordance with the diagnostic criteria of Petersen (2004) and Jak and Bondi (2009).
Who cannot join
- The participant:
- meets the criteria for a major neurocognitive disorder of the DSM-5.
- has a neurological disorder of infectious origin.
- has a psychiatric illness.
- has a severe uncompensated sensory deficit.
- is a substance abuser.
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- has had chronic depression or anxiety that has not stabilized for 3 months.
- refuses to participate.
- is participating in another intervention research project.
- is placed under the protection of justice.
- refuses to sign the consent form.
- is unable to express its consent.
- consumed toxic substances or alcohol at the time of the study.
Trial locations and contacts
2 sites in 1 country.
France2 sites
Laboratoire d'Étude des Mécanismes Cognitifs
Bron, 69676
Centre Mémoire Ressources Recherche de Lyon, Institut du Vieillissement, Hôpital des Charpennes
Villeurbanne, 69100
About this study
Official title: Episodic Specificity Induction: Research of Its Explanatory Mechanisms and Application to Normal and Pathological Ageing.
Episodic Specificity Induction (ESI) is a short training that improves the production of episodic details during autobiographical recall in young and elderly people without cognitive impairment. But it remains to be determined 1) whether the mechanisms targeted by the ESI affect memory or executive functioning and 2) whether amnestic type (aMCI) or dysexecutive type (dMCI) mild cognitive impairment patients would benefit differently from this training, which has never been tested. By comparing the effect of the ESI on these patients, this would open up new perspectives for their symptomatic care.
- Conditions
- Neurocognitive Disorders
- Medical subject headings
- Neurocognitive Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Elderly people without cognitive impairment | Not described | |
| Amnestic type mild cognitive impairment patients (aMCI) | Not described | |
| Dysexecutive type mild cognitive impairment patients (dMCI) | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average number of internal details
The participant sees 5 images evoking various events (e.g., a birthday, a restaurant) and describes for each one a related memory for 3 minutes. Each verbal production is recorded with a dictaphone, transcribed and then segmented into internal (episodic) or external (non-episodic) details according the coding procedure of Levine et al. (2002). The average number of internal details by autobiographical recall task is then calculated from these data.
Measured: Day 0 (at inclusion)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2020
- Study start11 Dec 2019
- Primary completion19 Apr 2024
- Study completion19 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neurocognitive DisordersStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04240405
- Sponsor's protocol ID
- 69HCL19-0373
- Acronym
- INSPE
- Status last verified
- Oct 2024
- First submitted
- 22 Jan 2020
- Last updated
- 10 Oct 2024
- 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 10 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Episodic Specificity Induction: Research of Its Explanatory Mechanisms and Application to Normal and Pathological Ageing.
- ClinicalTrials.gov ID
- NCT04240405
- Acronym / sponsor ID
- INSPE / 69HCL19-0373
- Conditions
- Neurocognitive Disorders
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 11 Dec 2019 (actual)
- Primary completion
- 19 Apr 2024 (actual)
- Study completion
- 19 Apr 2024 (actual)
- First posted
- 27 Jan 2020 (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.
Episodic Specificity Induction (ESI) is a short training that improves the production of episodic details during autobiographical recall in young and elderly people without cognitive impairment. But it remains to be determined 1) whether the mechanisms targeted by the ESI affect memory or executive functioning and 2) whether amnestic type (aMCI) or dysexecutive type (dMCI) mild cognitive impairment patients would benefit differently from this training, which has never been tested. By comparing the effect of the ESI on these patients, this would open up new perspectives for their symptomatic care.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Elderly people without cognitive impairment | – | – |
| Amnestic type mild cognitive impairment patients (aMCI) | – | – |
| Dysexecutive type mild cognitive impairment patients (dMCI) | – | – |
Who may qualify
- Ages
- 55 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- This study looks at a population of adults between the ages of 55 and 85 and 3 types of sample of subjects extracted from this population : 1. 24 elderly people without cognitive impairment 2. 24 amnestic type mild cognitive impairment patients (aMCI) 3. 24 dysexecutive type mild cognitive impairment patients (dMCI)
Key inclusion criteria (14 listed)
- has provided informed consent obtained in accordance with Good Clinical Practices.
- is affiliated to a social security system.
- speaks fluent French.
- is between 55 and 85 years of age.
- has a Montreal Cognitive Assessment (MoCA) score equal to or greater than 26;
Key exclusion criteria (13 listed)
- meets the criteria for a major neurocognitive disorder of the DSM-5.
- has a neurological disorder of infectious origin.
- has a psychiatric illness.
- has a severe uncompensated sensory deficit.
- is a substance abuser.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Average number of internal details
Time frame: Day 0 (at inclusion)
The participant sees 5 images evoking various events (e.g., a birthday, a restaurant) and describes for each one a related memory for 3 minutes. Each verbal production is recorded with a dictaphone, transcribed and then segmented into internal (episodic) or external (non-episodic) details according the coding procedure of Levine et al. (2002). The average number of internal details by autobiographical recall task is then calculated from these data.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neurocognitive Disorders, run by Hospices Civils de Lyon 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 14 inclusion and 13 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: finished, as of the sponsor's last update on 10 Oct 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Average number of internal details (time frame: Day 0 (at inclusion)). 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 10 Oct 2024.