Multiple SclerosisITEMSNCT02518776
Influence of Emotional Disorders and Executive on the Components Retrograde and Anterograde Episodic Memory in MS
A study testing Neuropsychological tests in people with Multiple Sclerosis, run by University Hospital, Caen at 1 site in France.
Trial summary
Multiple sclerosis (MS) is an inflammatory disease of the central nervous system responsible for physical disability but can also cause cognitive disturbances annoying social and professional life of patients with the disease. Read more about this study
- Who is it for?
- Ages 30 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Neuropsychological tests
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2010to Jul 2016
- 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 30 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Men and women 30-60 years of age
- Definite MS (McDonald criteria revised in 2005)
- EDSS <6
- Sick Shapes: Relapsing multiple sclerosis, Primary progressive multiple sclerosis
- All durations evolution
- French Mother tongue
- Signature of informed consent
Who cannot join
- Other neurological conditions, previous psychiatric or developmental diagnosis of MS
- Head injury sequelae
- Chronic alcohol or drugs Taking
- EDSS greater than or equal to 6
- Secondary Progressive Form
- Push and / or treatment with corticosteroids within one month
Show all 12Show fewer
- Treatments Amantadine, Modafinil introduced for less than 3 months
- Patient Trust
- Cognitive Assessment of less than one year (including in particular all or part of the balance sheet proposed in this project)
- Any visual motor deficit or incompatible with the award of cognitive tests
- For women, pregnancy, breastfeeding and / or lack of contraception (a pregnancy test will be done before the PET scan)
- Patient with indications against MRI
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Department of Neurologie, Caen Hospital University
Caen, Basse-Normandie, 14033
Gilles Defer, Professor, +33231064620, defer.gi@chu-caen.fr
Nathalie Derache
About this study
Multiple sclerosis (MS) is an inflammatory disease of the central nervous system responsible for physical disability but can also cause cognitive disturbances annoying social and professional life of patients with the disease. Various studies have shown that there was a breach of episodic memory, working memory, attention and executive functions regardless of the form of disease, disability or duration of disease progression.
The main objective of this study is to investigate the influence of emotional components and executive processes on the components retrograde and anterograde episodic memory (thanks to an original paradigm based on the emotional valence of the memory) in MS patients
- Conditions
- Multiple Sclerosis
- Being tested
- Neuropsychological tests
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuropsychological testsBehavioural
Neuropsychological tests
| Study group | Role | What they receive |
|---|---|---|
| Neuropsychological tests | Other | Not described Receives: Behavioral: Neuropsychological tests |
What is being measured
The primary outcome is the main question the study is designed to answer.
anterograde episodic memory: 3 scores of emotional ESR
3 scores of emotional ESR
Measured: baseline
retrograde episodic memory: 9 scores TEMP emotional
9 scores TEMP emotional
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2015 (estimated)
- Study startJun 2010
- Primary completionJul 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by University Hospital, CaenThe 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02518776
- Sponsor's protocol ID
- 09-016
- Acronym
- ITEMS
- Status last verified
- Aug 2015
- First submitted
- 6 Aug 2015
- Last updated
- 10 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Emotional Disorders and Executive on the Components Retrograde and Anterograde Episodic Memory in MS
- ClinicalTrials.gov ID
- NCT02518776
- Acronym / sponsor ID
- ITEMS / 09-016
- Conditions
- Multiple Sclerosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- Jun 2010
- Primary completion
- Jul 2016 (estimated)
- First posted
- 10 Aug 2015 (estimated)
- 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.
Multiple sclerosis (MS) is an inflammatory disease of the central nervous system responsible for physical disability but can also cause cognitive disturbances annoying social and professional life of patients with the disease. Various studies have shown that there was a breach of episodic memory, working memory, attention and executive functions regardless of the form of disease, disability or duration of disease progression.
The main objective of this study is to investigate the influence of emotional components and executive processes on the components retrograde and anterograde episodic memory (thanks to an original paradigm based on the emotional valence of the memory) in MS patients
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Neuropsychological tests | Other | Behavioral: Neuropsychological tests |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Men and women 30-60 years of age
- Definite MS (McDonald criteria revised in 2005)
- EDSS <6
- Sick Shapes: Relapsing multiple sclerosis, Primary progressive multiple sclerosis
- All durations evolution
Key exclusion criteria (12 listed)
- Other neurological conditions, previous psychiatric or developmental diagnosis of MS
- Head injury sequelae
- Chronic alcohol or drugs Taking
- EDSS greater than or equal to 6
- Secondary Progressive Form
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 testsNeuropsychological tests | Behavioural | Neuropsychological tests |
Primary outcome
anterograde episodic memory: 3 scores of emotional ESR
Time frame: baseline
3 scores of emotional ESR
retrograde episodic memory: 9 scores TEMP emotional
Time frame: baseline
9 scores TEMP emotional
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2015.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neuropsychological tests in people with Multiple Sclerosis, run by University Hospital, Caen 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 7 inclusion and 12 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 10 Aug 2015. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
anterograde episodic memory: 3 scores of emotional ESR (time frame: baseline). The study lists 2 primary outcomes in all. 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 Aug 2015.