NCT01659593

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
140

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 6, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 8, 2012

Completed
24 days until next milestone

Study Start

First participant enrolled

September 1, 2012

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
Last Updated

March 8, 2016

Status Verified

March 1, 2016

Enrollment Period

4 years

First QC Date

August 6, 2012

Last Update Submit

March 7, 2016

Conditions

Cognitive DisordersMultiple Sclerosis

Keywords

cognitive disordersmultiple sclerosisneuropsychology

Outcome Measures

Primary Outcomes (1)

  • cognitive function measured by SRT-List score

    0-9 months

Secondary Outcomes (1)

  • quality of life measured by MusiQol

    0 -9 months

Other Outcomes (1)

  • cognitive function: verbal memory (SRT), visuospatial memory (10/36), verbal fluency (animal categories),empans, code ,DO80, cognitive complaint

    0-9 months

Study Arms (2)

procog

EXPERIMENTAL

cognitive remedial program 13 sessions over a 6-month period

Other: procog

DISINT

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

procogOTHER

3 to 5 people group program

procog
PlaceboOTHER
DISINT

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • ≤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 )

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University hospital Nancy

Nancy, 54000, France

RECRUITING

MeSH Terms

Conditions

Cognitive DysfunctionMultiple Sclerosis

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental DisordersDemyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Marc DEBOUVERIE, Professor

    CHU NANCY

    PRINCIPAL INVESTIGATOR

  • Eric BERGER, MD

    CHU DE BESANCON

    PRINCIPAL INVESTIGATOR

  • Thibaut MOREAU, Professor

    Centre Hospitalier Universitaire Dijon

    PRINCIPAL INVESTIGATOR

  • Jérôme de Sèze, Professor

    CHU de STRASBOURG

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 6, 2012

First Posted

August 8, 2012

Study Start

September 1, 2012

Primary Completion

September 1, 2016

Study Completion

June 1, 2018

Last Updated

March 8, 2016

Record last verified: 2016-03

Locations

FR(1)