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

Evaluation of the Efficiency of a Cognitive Remedial Program (PROCOG-SEP) Designed for Multiple Sclerosis Patients. A Double Blind Randomized Multicenter Trial.

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01659593

Acronym

PROCOG-SEP

Enrollment

140

Registered

2012-08-08

Start date

2012-09-30

Completion date

2018-06-30

Last updated

2016-03-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cognitive Disorders, Multiple Sclerosis

Keywords

cognitive disorders, multiple sclerosis, neuropsychology

Brief 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.

Interventions

OTHERprocog

3 to 5 people group program

OTHERPlacebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

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

* 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

Design outcomes

Primary

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

Secondary

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

Other

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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026