Status unknownNCT01659593PROCOG-SEPUpdated Mar 8, 2016

Evaluation of the Efficiency of a Cognitive Remedial Program (PROCOG-SEP) Designed for Multiple Sclerosis Patients

An interventional study of procog and Placebo in Cognitive Disorders and Multiple Sclerosis, sponsored by Central Hospital, Nancy, France. Status unknown at 1 site in France. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2016-03-08.

Sponsored by Central Hospital, Nancy, France · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Mar 2016), so the status shown — last known as Recruiting — may be out of date.

Phase: Not applicable
Study type: Interventional
Enrollment: 140
Allocation: Randomized
Ages: 18 Years to 60 Years
Sex: All

Study 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.

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 studied

Cognitive Disorders
Multiple Sclerosis

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Keywords

cognitive disorders
multiple sclerosis
neuropsychology

In context

Multiple Sclerosis

3,460 studies on the registry are indexed under Multiple Sclerosis; 661 are open to participants now.

This study's planned enrollment of 140 is above the median of 50 across 2,342 interventional studies indexed under Multiple Sclerosis.

Browse Multiple Sclerosis studies →

Lead sponsor

Central Hospital, Nancy, France is the lead sponsor of 778 studies on the registry; 183 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 60 Years
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

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 )

Exclusion criteria

Exclusion Criteria:

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

Study design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Triple (Participant, Investigator, Outcomes assessor)
Enrollment: 140 participants (estimated)

Study arms

Experimental
procog
cognitive remedial program 13 sessions over a 6-month period
Other: procog
Placebo comparator
DISINT
Interactive discussion program of 13 group sessions in a 6-month period
Other: Placebo

Interventions

Otherprocog
3 to 5 people group program
OtherPlacebo

What researchers measure

Primary outcomes

cognitive function measured by SRT-List score
Time frame: 0-9 months

Secondary outcomes

quality of life measured by MusiQol
Time frame: 0 -9 months

Other outcomes

cognitive function: verbal memory (SRT), visuospatial memory (10/36), verbal fluency (animal categories),empans, code ,DO80, cognitive complaint
Time frame: 0-9 months

Study locations

1 of 1 sites recruiting

University hospital Nancy
Nancy, 54000, France
- Marc DEBOUVERIE, MD · Contact · m.debouverie@chu-nancy.fr · 00 33 3 83 15 16 88
- Marc Debouverie, MD,PhD · Principal investigator
Recruiting

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Mar 8, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01659593
Lead sponsor: Central Hospital, Nancy, France
Collaborators: University Hospital, Strasbourg, France, Centre Hospitalier Universitaire Dijon, Centre Hospitalier Universitaire de Besancon
Responsible party: Sponsor
First posted: Aug 8, 2012
Start date: Sep 2012
Primary completion: Sep 2016 (estimated)
Completion: Jun 2018 (estimated)
Last update: Mar 8, 2016

Study contacts

Marc DEBOUVERIE, Professor

principal investigator · CHU NANCY

Eric BERGER, MD

principal investigator · CHU DE BESANCON

Thibaut MOREAU, Professor

principal investigator · Centre Hospitalier Universitaire Dijon

Jérôme de Sèze, Professor

principal investigator · CHU de STRASBOURG

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2016. You cannot join it, but the record below documents what was studied.

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