NCT01492023

Brief Summary

The purpose of this study is to determine whether neuropsychological rehabilitation focused on attention retraining and teaching compensatory strategies has positive effects on cognitive performance, quality of life (QoL)and perceived cognitive deficits in patients with MS. The hypothesis is that the neuropsychological intervention shows positive effects on cognitive performance, QoL and perceived cognitive deficits.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
97

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2010

Geographic Reach
1 country

3 active sites

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2010

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

December 4, 2011

Completed
10 days until next milestone

First Posted

Study publicly available on registry

December 14, 2011

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2012

Completed
Last Updated

March 11, 2013

Status Verified

March 1, 2013

Enrollment Period

1.4 years

First QC Date

December 4, 2011

Last Update Submit

March 8, 2013

Conditions

Multiple Sclerosis

Keywords

neuropsychologicalrehabilitationmultiple sclerosisRCT study

Outcome Measures

Primary Outcomes (3)

  • Objective cognitive performance

    effects of rehabilitation on objective cognitive performance: SDMT

    six months

  • Subjective cognitive performance

    The effects of rehabilitation on subjective cognitive performance: perceived cognitive deficits (Perceived Deficits Questionnaire, PDQ)

    six months

  • Goal achievement

    Goal achievement: Goal Attainment Scaling (GAS)

    six months

Secondary Outcomes (6)

  • Quality of life

    six months

  • Objective cognitive performance

    six months

  • Mood

    six months

  • Fatigue

    six months

  • Subjective cognitive performance

    six months

  • +1 more secondary outcomes

Study Arms (2)

control

control group: no intervention

neuropsychological rehabilitation

intervention group: neuropsychological rehabilitation (13 times 60 minutes, once per week, during 13 weeks) control group: no intervention

Behavioral: neuropsychological rehabilitation

Interventions

neuropsychological rehabilitationBEHAVIORAL

attention retraining and teaching compensatory strategies as well as offering psychological support to better cope with cognitive impairments (13 times 60 minutes, once per week during 13 weeks)

neuropsychological rehabilitation

Eligibility Criteria

Age18 Years - 58 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Patients with MS are collected from community by informing about the study via information letters send to the members of local MS Associations

You may qualify if:

  • clinically definite MS
  • EDSS \< 6
  • age 18-58 years
  • subjective cognitive problems and objective decline in attention

You may not qualify if:

  • other neurological disease than MS
  • psychiatric diagnosis
  • severe depression
  • secondary progressive or primary progressive course of MS
  • EDSS\>=6
  • alcohol or drug abuse
  • relapse during the preceding month of study entry
  • neuropsychological rehabilitation during the study
  • no subjective cognitive cognitive problems and /or no decline in attention
  • overall cognitive impairment (performance in all tests of BRBNT under -1.5 SD compared to norms of healthy controls)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Masku Neurological Rehabilitation Centre

Masku, 212521, Finland

Location

Seinajoki Central Hospital

Seinäjoki, 60220, Finland

Location

Tampere University Hospital

Tampere, Finland

Location

Biospecimen

Retention: NONE RETAINED

A randomised, controlled, single-blind study

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Päivi I Hämäläinen, adjunct prof

    Finnish MS Society / Masku Neurological Rehabilitation Centre

    STUDY DIRECTOR

  • Keijo Koivisto, Prof

    Seinajoki Central Hospital

    STUDY CHAIR

  • Eija M Rosti-Otajärvi, PhD

    Tampere University Hospital

    PRINCIPAL INVESTIGATOR

  • Anu Mäntynen, MA

    Seinajoki Central Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
neuropsychologist, adjunct professor

Study Record Dates

First Submitted

December 4, 2011

First Posted

December 14, 2011

Study Start

November 1, 2010

Primary Completion

April 1, 2012

Study Completion

May 1, 2012

Last Updated

March 11, 2013

Record last verified: 2013-03

Locations

FI(3)