Cognitive DisordersPROCOG-SEPNCT01659593
Evaluation of the Efficiency of a Cognitive Remedial Program (PROCOG-SEP) Designed for Multiple Sclerosis Patients
A study testing procog in people with Cognitive Disorders and Multiple Sclerosis, run by Central Hospital, Nancy, France at 1 site in France.
Trial summary
Cognitive disorders are well-known in multiple sclerosis (MS), even in earlier stages of the disease. They effect personal life. Their management may be overlooked. The evidence-based program proposes exercises to both stimulate preserved functions and develop new abilities compensating for cognitive disabilities. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Cognitive Disorders, Multiple Sclerosis
- What is being tested?
- procog
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 140 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2012to Jun 2018
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 18 ≤Aged ≤ 60 at baseline
- Must be able to understand and read french language
- Must sign the informed consent form
- Must be affiliate to French social security
- multiple sclerosis confirmed by Mac Donald criteria
- EDSS ≤ 6.0 at baseline
- Duration of multiple sclerosis ≤ 30 years at baseline
- mild cognitive disorder ( at least 2 cognitive tasks, at most 5 )
Who cannot join
- under legal protection
- treatment by corticosteroids in the past 4 weeks
- cognitive remedial program already done
- neuropsychologic assessment in the past 2 months
- having an other chronic disease
- having an other neurologic disease
- alcohol or drug addiction
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
University hospital Nancy
Nancy, 54000
Marc DEBOUVERIE, MD, 00 33 3 83 15 16 88, m.debouverie@chu-nancy.fr
Marc Debouverie, MD,PhD
About this study
Official title: Evaluation of the Efficiency of a Cognitive Remedial Program (PROCOG-SEP) Designed for Multiple Sclerosis Patients. A Double Blind Randomized Multicenter Trial.
Cognitive disorders are well-known in multiple sclerosis (MS), even in earlier stages of the disease. They effect personal life. Their management may be overlooked. The evidence-based program proposes exercises to both stimulate preserved functions and develop new abilities compensating for cognitive disabilities.
Aim of the study is to evaluate the efficiency of the remedial program (PROCOG-SEP) designed for MS patients, compared to an interactive discussion program(DISINT) 140 multiple sclerosis patients will be randomly assigned in one the program for 13 sessions over a 6-month period.
Main outcome criteria is evolution of SRT-LIST before and after program.
- Conditions
- Cognitive Disorders, Multiple Sclerosis
- Being tested
- procog, Placebo
- Keywords
- cognitive disorders, multiple sclerosis, neuropsychology
- Medical subject headings
- Cognitive Dysfunction, Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
procogOther
3 to 5 people group program
PlaceboOther
| Study group | Role | What they receive |
|---|---|---|
| procog | Experimental | cognitive remedial program 13 sessions over a 6-month period Receives: Other: procog |
| DISINT | Placebo comparator | Interactive discussion program of 13 group sessions in a 6-month period Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
cognitive function measured by SRT-List score
Measured: 0-9 months
Secondary outcomes (1)
quality of life measured by MusiQol
Measured: 0 -9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2012 (estimated)
- Study startSep 2012
- Primary completionSep 2016 (estimated)
- Study completionJun 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive DisordersStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Strasbourg, France, Centre Hospitalier Universitaire Dijon, Centre Hospitalier Universitaire de Besancon
- Responsible party
- Sponsor
- Investigators
- Marc DEBOUVERIE, Professor, Principal investigator, Central Hospital, Nancy, FranceEric BERGER, MD, Principal investigator, CHU DE BESANCONThibaut MOREAU, Professor, Principal investigator, Centre Hospitalier Universitaire DijonJérôme de Sèze, Professor, Principal investigator, CHU de STRASBOURG
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01659593
- Sponsor's protocol ID
- PROCOG-SEP
- Acronym
- PROCOG-SEP
- Status last verified
- Mar 2016
- First submitted
- 6 Aug 2012
- Last updated
- 8 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficiency of a Cognitive Remedial Program (PROCOG-SEP) Designed for Multiple Sclerosis Patients. A Double Blind Randomized Multicenter Trial.
- ClinicalTrials.gov ID
- NCT01659593
- Acronym / sponsor ID
- PROCOG-SEP / PROCOG-SEP
- Conditions
- Cognitive Disorders, Multiple Sclerosis
- Keywords
- cognitive disorders, multiple sclerosis, neuropsychology
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Collaborators
- University Hospital, Strasbourg, France, Centre Hospitalier Universitaire Dijon, Centre Hospitalier Universitaire de Besancon
- Study start
- Sep 2012
- Primary completion
- Sep 2016 (estimated)
- Study completion
- Jun 2018 (estimated)
- First posted
- 8 Aug 2012 (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.
Cognitive disorders are well-known in multiple sclerosis (MS), even in earlier stages of the disease. They effect personal life. Their management may be overlooked. The evidence-based program proposes exercises to both stimulate preserved functions and develop new abilities compensating for cognitive disabilities.
Aim of the study is to evaluate the efficiency of the remedial program (PROCOG-SEP) designed for MS patients, compared to an interactive discussion program(DISINT) 140 multiple sclerosis patients will be randomly assigned in one the program for 13 sessions over a 6-month period.
Main outcome criteria is evolution of SRT-LIST before and after program.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| procog | Experimental | Other: procogcognitive remedial program 13 sessions over a 6-month period |
| DISINT | Placebo comparator | Other: PlaceboInteractive discussion program of 13 group sessions in a 6-month period |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 18 ≤Aged ≤ 60 at baseline
- Must be able to understand and read french language
- Must sign the informed consent form
- Must be affiliate to French social security
- multiple sclerosis confirmed by Mac Donald criteria
Key exclusion criteria (7 listed)
- under legal protection
- treatment by corticosteroids in the past 4 weeks
- cognitive remedial program already done
- neuropsychologic assessment in the past 2 months
- having an other chronic disease
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 |
|---|---|---|
| procog3 to 5 people group program | Other | procog |
| Placebo | Other | DISINT |
Primary outcome
cognitive function measured by SRT-List score
Time frame: 0-9 months
1 secondary outcome
quality of life measured by MusiQol
Time frame: 0 -9 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2016.
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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.
Marc DEBOUVERIE, Professor principal investigator
Central Hospital, Nancy, France
Eric BERGER, MD principal investigator
CHU DE BESANCON
Thibaut MOREAU, Professor principal investigator
Centre Hospitalier Universitaire Dijon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing procog in people with Cognitive Disorders and Multiple Sclerosis, run by Central Hospital, Nancy, France 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 8 inclusion and 7 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 8 Mar 2016. 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. Some participants in this study may receive a placebo. 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?
cognitive function measured by SRT-List score (time frame: 0-9 months). 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 8 Mar 2016.