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

Primary Purpose

Cognitive Disorders, Multiple Sclerosis

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
procog
Placebo
Sponsored by
Central Hospital, Nancy, France
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cognitive Disorders focused on measuring cognitive disorders, multiple sclerosis, neuropsychology

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept 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

Sites / Locations

  • University hospital NancyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

procog

DISINT

Arm Description

cognitive remedial program 13 sessions over a 6-month period

Interactive discussion program of 13 group sessions in a 6-month period

Outcomes

Primary Outcome Measures

cognitive function measured by SRT-List score

Secondary Outcome Measures

quality of life measured by MusiQol

Full Information

First Posted
August 6, 2012
Last Updated
March 7, 2016
Sponsor
Central Hospital, Nancy, France
Collaborators
University Hospital, Strasbourg, France, Centre Hospitalier Universitaire Dijon, Centre Hospitalier Universitaire de Besancon
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1. Study Identification

Unique Protocol Identification Number
NCT01659593
Brief Title
Evaluation of the Efficiency of a Cognitive Remedial Program (PROCOG-SEP) Designed for Multiple Sclerosis Patients
Acronym
PROCOG-SEP
Official Title
Evaluation of the Efficiency of a Cognitive Remedial Program (PROCOG-SEP) Designed for Multiple Sclerosis Patients. A Double Blind Randomized Multicenter Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2016
Overall Recruitment Status
Unknown status
Study Start Date
September 2012 (undefined)
Primary Completion Date
September 2016 (Anticipated)
Study Completion Date
June 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Central Hospital, Nancy, France
Collaborators
University Hospital, Strasbourg, France, Centre Hospitalier Universitaire Dijon, Centre Hospitalier Universitaire de Besancon

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cognitive Disorders, Multiple Sclerosis
Keywords
cognitive disorders, multiple sclerosis, neuropsychology

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
140 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
procog
Arm Type
Experimental
Arm Description
cognitive remedial program 13 sessions over a 6-month period
Arm Title
DISINT
Arm Type
Placebo Comparator
Arm Description
Interactive discussion program of 13 group sessions in a 6-month period
Intervention Type
Other
Intervention Name(s)
procog
Intervention Description
3 to 5 people group program
Intervention Type
Other
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
cognitive function measured by SRT-List score
Time Frame
0-9 months
Secondary Outcome Measure Information:
Title
quality of life measured by MusiQol
Time Frame
0 -9 months
Other Pre-specified Outcome Measures:
Title
cognitive function: verbal memory (SRT), visuospatial memory (10/36), verbal fluency (animal categories),empans, code ,DO80, cognitive complaint
Time Frame
0-9 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marc DEBOUVERIE, Professor
Organizational Affiliation
CHU NANCY
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Eric BERGER, MD
Organizational Affiliation
CHU de BESANCON
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Thibaut MOREAU, Professor
Organizational Affiliation
Centre Hospitalier Universitaire Dijon
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jérôme de Sèze, Professor
Organizational Affiliation
CHU de STRASBOURG
Official's Role
Principal Investigator
Facility Information:
Facility Name
University hospital Nancy
City
Nancy
ZIP/Postal Code
54000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marc DEBOUVERIE, MD
Phone
00 33 3 83 15 16 88
Email
m.debouverie@chu-nancy.fr
First Name & Middle Initial & Last Name & Degree
Marc Debouverie, MD,PhD

12. IPD Sharing Statement

Learn more about this trial

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

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