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The Effects of Attention Retraining in MS (MSattention)

This study has been completed.
Sponsor:
Collaborators:
Social Insurance Institution, Finland
Tampere University Hospital
Seinajoki Central Hospital
Information provided by (Responsible Party):
Paivi Hamalainen, Finnish MS Society
ClinicalTrials.gov Identifier:
NCT01492023
First received: December 4, 2011
Last updated: March 8, 2013
Last verified: March 2013
  Purpose

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.


Condition Intervention
Multiple Sclerosis
Behavioral: neuropsychological rehabilitation

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: The Effects of Attention Retraining on Cognitive Performance, QoL and Perceived Cognitive Impairment in MS - a Single Blind, Randomized, Controlled Study

Resource links provided by NLM:


Further study details as provided by Finnish MS Society:

Primary Outcome Measures:
  • Objective cognitive performance [ Time Frame: six months ] [ Designated as safety issue: No ]
    effects of rehabilitation on objective cognitive performance: SDMT

  • Subjective cognitive performance [ Time Frame: six months ] [ Designated as safety issue: No ]
    The effects of rehabilitation on subjective cognitive performance: perceived cognitive deficits (Perceived Deficits Questionnaire, PDQ)

  • Goal achievement [ Time Frame: six months ] [ Designated as safety issue: No ]
    Goal achievement: Goal Attainment Scaling (GAS)


Secondary Outcome Measures:
  • Quality of life [ Time Frame: six months ] [ Designated as safety issue: No ]
    The effects of rehabilitation on QoL: WHOQOL-Bref

  • Objective cognitive performance [ Time Frame: six months ] [ Designated as safety issue: No ]
    The effects of rehabilitation on cognitive performances: test of Brief Repeatable Battery of Neuropsychological Tests (BRBNT), Trail Making Test, Stroop test

  • Mood [ Time Frame: six months ] [ Designated as safety issue: No ]
    The effects of rehabilitation on mood: Beck Depression Inventory II (BDI II)

  • Fatigue [ Time Frame: six months ] [ Designated as safety issue: No ]
    The effects of rehabilitation on self-perceived feeling of fatigue: Fatigue Scale for Motor and Cognitive Fatigue (FSMC)

  • Subjective cognitive performance [ Time Frame: six months ] [ Designated as safety issue: No ]
    The effects of rehabilitation on subjective cognitive performance evaluated by the patient him/herself or the significant other: Multiple Sclerosis Neuropsychological Questionnaire (MSNQ-P, MSNQ-I)

  • The impact of the disease [ Time Frame: six months ] [ Designated as safety issue: No ]
    The effects of rehabilitation on the impact of the disease: Multiple Sclerosis Impact Scale (MSIS-29)


Biospecimen Retention:   None Retained

A randomised, controlled, single-blind study


Enrollment: 97
Study Start Date: November 2010
Study Completion Date: May 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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
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)

Detailed Description:

Background: Cognitive impairments are a typical manifestation of multiple sclerosis (MS). According to previous studies, neuropsychological rehabilitation may improve cognitive performance in MS. However, the quality of previous studies is low and, accordingly, the evidence on the effects of neuropsychological rehabilitation is low to modest.

Objective: To study whether neuropsychological rehabilitation improves cognitive performance, QoL and perceived cognitive deficits in patients with MS.

Methods: Altogether 100 patients with MS are randomised either to intervention or to control group in three different study sites. All the study subjects are assessed with neuropsychological tests as well as self-rating questionnaires evaluating mood, QoL, cognitive deficits, fatigue and impact of the disease at baseline, after three months (immediately after intervention) and after six months. Patients in the intervention group are offered with neuropsychological rehabilitation conducted once a week during thirteen weeks. Patients in the control group do not receive any intervention.

Results: The effects of intervention on cognitive performance, QoL and perceived cognitive impairments are evaluated using appropriate statistical procedures and comparing the differences between the intervention and the control group.

The present status: The baseline assessments have been performed and the intervention will be conducted between September and December, 2011.

  Eligibility

Ages Eligible for Study:   18 Years to 58 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-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

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01492023

Locations
Finland
Masku Neurological Rehabilitation Centre
Masku, Finland, 212521
Seinajoki Central Hospital
Seinäjoki, Finland, 60220
Tampere University Hospital
Tampere, Finland
Sponsors and Collaborators
Finnish MS Society
Social Insurance Institution, Finland
Tampere University Hospital
Seinajoki Central Hospital
Investigators
Study Director: Päivi I Hämäläinen, adjunct prof Finnish MS Society / Masku Neurological Rehabilitation Centre
Study Chair: Keijo Koivisto, Prof Seinajoki Central Hospital
Principal Investigator: Eija M Rosti-Otajärvi, PhD Tampere University Hospital
Principal Investigator: Anu Mäntynen, MA Seinäjoki Central Hospital
  More Information

No publications provided

Responsible Party: Paivi Hamalainen, neuropsychologist, adjunct professor, Finnish MS Society
ClinicalTrials.gov Identifier: NCT01492023     History of Changes
Other Study ID Numbers: MS1209
Study First Received: December 4, 2011
Last Updated: March 8, 2013
Health Authority: Finland: Ethics Committee

Keywords provided by Finnish MS Society:
neuropsychological
rehabilitation
multiple sclerosis
RCT study

Additional relevant MeSH terms:
Multiple Sclerosis
Sclerosis
Autoimmune Diseases
Autoimmune Diseases of the Nervous System
Demyelinating Autoimmune Diseases, CNS
Demyelinating Diseases
Immune System Diseases
Nervous System Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on November 25, 2014