Multiple Sclerosis, Relapsing-RemittingSELFSEPNCT05648292
The Relationships Between Personal Identity, Autobiographical Memory and Future Thinking in People With Multiple Sclerosis
An observational study of Multiple Sclerosis, Relapsing-Remitting and Healthy Controls, run by Centre d'Investigation Clinique et Technologique 805 at 1 site in France.
Trial summary
Personal identity is composed of multiple facets of the self that are constructed and nourished through memories of past experiences (i.e., autobiographical memory) and the imagination of events that may occur in the future (i.e., future thinking) . Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Multiple Sclerosis, Relapsing-Remitting, Healthy Controls
- What is being tested?
- Neuropsychological tests and psychological questionnaires
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 90 participants
- Where
- 1 siteFrance
- Study dates
- 7 Dec 2022to 7 Jun 2025
- How long will I take part?
- 15 Days
- 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 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Primary care clinic
Who may be able to join
- Diagnosis of relapsing-remitting MS according to the McDonald's revised diagnostic criteria
- People aged between 18 and 55
- French native speaker
- Access to a computer or tablet, equipped with internet access, a camera and a microphone
- Non-inclusion Criteria:
- MS relapse in the month prior to the inclusion
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- Treatment with corticosteroids during the month preceding the inclusion
- Form of MS other than the relapsing-remitting form
- Neurological history (other than MS for patients), history or current presence of psychiatric disorders (e.g., depression, anxiety disorders, schizophrenia), substance abuse (e.g., alcohol, cannabis; past or present)
- Other diagnosed chronic pathology(ies) (other than MS for patients)
- Severe cognitive impairment
- Persons mentioned in Articles L1121-6 to L1121-8 in the French law (minors, persons deprived of liberty, adults subject to protective measures)
- For the control group:
- People aged between 18 and 55
- Matched in age, gender and level in education
- French native speaker
- Access to a computer or tablet, equipped with internet access, a camera and a microphone
- Non-inclusion Criteria:
- Neurological history (other than MS for patients), history or current presence of psychiatric disorders (e.g., depression, anxiety disorders, schizophrenia), substance abuse (e.g., alcohol, cannabis; past or present)
- Other diagnosed chronic pathology(ies) (other than MS for patients)
- Severe cognitive impairment
- Persons mentioned in Articles L1121-6 to L1121-8 in the French law (minors, persons deprived of liberty, adults subject to protective measures)
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Hopital Raymond Poincaré Garches
Garches, Hauts De Seine, 92380
Lucine Sonnet, 01 47 10 46 14, lucine.sonnet@aphp.fr
About this study
Personal identity is composed of multiple facets of the self that are constructed and nourished through memories of past experiences (i.e., autobiographical memory) and the imagination of events that may occur in the future (i.e., future thinking) .
While our previous work has shown that people with relapsing-remitting multiple sclerosis (pwRRMS) have autobiographical memory and future thought disorders, their impact on personal identity has not yet been explored. Based on a cognitive and clinical neuropsychology approach, this research project aims to better understand the cognitive mechanisms involved in the relationship between identity, autobiographical memory and future thinking in pwRRMS. We will examine the extent to which pwRRMS manage to maintain and reshape their identity through life experiences, with a particular interest in the potential integration of the disease as a facet of their identity. In addition, we will explore the positive and/or negative consequences of disease-related identity changes on emotional well-being and quality of life, as well as their links with the duration and severity of the disease. Overall, this research project will contribute to identify new therapeutic levers that can be used for the development of adapted and personalized care.
- Being tested
- Neuropsychological tests and psychological questionnaires
- Medical subject headings
- Multiple Sclerosis, Relapsing-Remitting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuropsychological tests and psychological questionnairesBehavioural
- The clinical group will complete:
- the BCcogSEP: a comprehensive neuropsychological examination
- the IAM and I WILL BE tasks; experimental neuropsychological tasks to assess autobiographical memory, future thinking and personal identity
- A series of questionnaires including the BRIEF COPE, the Connor Davidson Resilience Scale, the Satisfaction with Life Scale and the Hospital Anxiety and Depression Scale, which respectively assess coping strategies, resilience, life satisfaction and anxiety/depression
- The control group will complete:
- the IAM and I WILL BE tasks; experimental neuropsychological tasks to assess autobiographical memory, future thinking and personal identity
- A series of questionnaires including the BRIEF COPE, the Connor Davidson Resilience Scale, the Satisfaction with Life Scale and the Hospital Anxiety and Depression Scale, which respectively assess coping strategies, resilience, life satisfaction and anxiety/depression
| Study group | Role | What they receive |
|---|---|---|
| Clinical group | 45 individuals with relapsing-remitting multiple sclerosis Receives: Behavioral: Neuropsychological tests and psychological questionnaires | |
| Control group | 45 individuals with no chronic disease, matched in age, gender and level of education Receives: Behavioral: Neuropsychological tests and psychological questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relationships between personal identity, autobiographical memory and future thinking
Scores obtained at the I AM and I WILL BE tasks assessing the access, qualitative properties of self-concepts, episodic richness and temporal organization of past and future events around self-concepts (between-group comparisons, pwRRMS versus control group)
Measured: 15 days
Secondary outcomes (1)
Relationships between personal identity, psychological functioning and clinical characteristics
Correlations between IAM and I WILL BE scores and scores obtained at the different questionnaires (BRIEF COPE, Connor Davidson Resilience Scale, Satisfaction with Life Scale, Hospital Anxiety and Depression Scale) Correlations between IAM and I WILL BE scores and level of functional disability (Expanded Disability Status Scale) Correlations between IAM and I WILL BE scores and disease duration
Measured: 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2022
- Study start7 Dec 2022
- Primary completion7 Dec 2024 (estimated)
- Study completion7 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple Sclerosis, Relapsing-RemittingStudies of the same condition, open and under way.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 90 participants (estimated)
- Target duration
- 15 Days
Sponsor and investigators
- Lead sponsor
- Centre d'Investigation Clinique et Technologique 805
- Sponsor type
- University, hospital or other
- Collaborators
- University Paris 8 Vincennes Saint Denis, ARSEP foundation
- Responsible party
- Principal investigator, Alexandra Ernst, Centre d'Investigation Clinique et Technologique 805
- Investigators
- Alexandra ERNST, PhD, Principal investigator, Laboratoire DysCo - Université Paris 8
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05648292
- Sponsor's protocol ID
- 2022-A00495-38
- Acronym
- SELFSEP
- Status last verified
- Sep 2023
- First submitted
- 5 Dec 2022
- Last updated
- 6 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationships Between Personal Identity, Autobiographical Memory and Future Thinking in People With Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT05648292
- Acronym / sponsor ID
- SELFSEP / 2022-A00495-38
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Centre d'Investigation Clinique et Technologique 805University, hospital or other
- Collaborators
- University Paris 8 Vincennes Saint Denis, ARSEP foundation
- Study start
- 7 Dec 2022 (actual)
- Primary completion
- 7 Dec 2024 (estimated)
- Study completion
- 7 Jun 2025 (estimated)
- First posted
- 13 Dec 2022 (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.
Personal identity is composed of multiple facets of the self that are constructed and nourished through memories of past experiences (i.e., autobiographical memory) and the imagination of events that may occur in the future (i.e., future thinking) .
While our previous work has shown that people with relapsing-remitting multiple sclerosis (pwRRMS) have autobiographical memory and future thought disorders, their impact on personal identity has not yet been explored. Based on a cognitive and clinical neuropsychology approach, this research project aims to better understand the cognitive mechanisms involved in the relationship between identity, autobiographical memory and future thinking in pwRRMS. We will examine the extent to which pwRRMS manage to maintain and reshape their identity through life experiences, with a particular interest in the potential integration of the disease as a facet of their identity. In addition, we will explore the positive and/or negative consequences of disease-related identity changes on emotional well-being and quality of life, as well as their links with the duration and severity of the disease. Overall, this research project will contribute to identify new therapeutic levers that can be used for the development of adapted and personalized care.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 15 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Clinical group | – | Behavioral: Neuropsychological tests and psychological questionnaires45 individuals with relapsing-remitting multiple sclerosis |
| Control group | – | Behavioral: Neuropsychological tests and psychological questionnaires45 individuals with no chronic disease, matched in age, gender and level of education |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Primary care clinic
Key inclusion criteria (22 listed)
- Diagnosis of relapsing-remitting MS according to the McDonald's revised diagnostic criteria
- People aged between 18 and 55
- French native speaker
- Access to a computer or tablet, equipped with internet access, a camera and a microphone
- MS relapse in the month prior to the inclusion
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Neuropsychological tests and psychological questionnaires* The clinical group will complete: * the BCcogSEP: a comprehensive neuropsychological examination * the IAM and I WILL BE tasks; experimental neuropsychological tasks to assess autobiographical memory, future thinking and personal identity * A series of questionnaires including the BRIEF COPE, the Connor Davidson Resilience Scale, the Satisfaction with Life Scale and the Hospital Anxiety and Depression Scale, which respectively assess coping strategies, resilience, life satisfaction and anxiety/depression * The control group will complete: * the IAM and I WILL BE tasks; experimental neuropsychological tasks to assess autobiographical memory, future thinking and personal identity * A series of questionnaires including the BRIEF COPE, the Connor Davidson Resilience Scale, the Satisfaction with Life Scale and the Hospital Anxiety and Depression Scale, which respectively assess coping strategies, resilience, life satisfaction and anxiety/depression | Behavioural | Clinical group, Control group |
Primary outcome
Relationships between personal identity, autobiographical memory and future thinking
Time frame: 15 days
Scores obtained at the I AM and I WILL BE tasks assessing the access, qualitative properties of self-concepts, episodic richness and temporal organization of past and future events around self-concepts (between-group comparisons, pwRRMS versus control group)
1 secondary outcome
Relationships between personal identity, psychological functioning and clinical characteristics
Time frame: 15 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2023.
- Individual participant dataSharing planned: No
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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.
Alexandra ERNST, PhD principal investigator
Laboratoire DysCo - Université Paris 8
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis, Relapsing-Remitting and Healthy Controls, run by Centre d'Investigation Clinique et Technologique 805 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 22 inclusion and 0 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 6 Sep 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 Alexandra Ernst, PhD (+33628496210, aernst@univ-paris8.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relationships between personal identity, autobiographical memory and future thinking (time frame: 15 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 6 Sep 2023.