The Effects of Attention Retraining in MS (MSattention)
|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|
- Objective cognitive performance [ Time Frame: six months ]effects of rehabilitation on objective cognitive performance: SDMT
- Subjective cognitive performance [ Time Frame: six months ]The effects of rehabilitation on subjective cognitive performance: perceived cognitive deficits (Perceived Deficits Questionnaire, PDQ)
- Goal achievement [ Time Frame: six months ]Goal achievement: Goal Attainment Scaling (GAS)
- Quality of life [ Time Frame: six months ]The effects of rehabilitation on QoL: WHOQOL-Bref
- Objective cognitive performance [ Time Frame: six months ]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 ]The effects of rehabilitation on mood: Beck Depression Inventory II (BDI II)
- Fatigue [ Time Frame: six months ]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 ]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 ]The effects of rehabilitation on the impact of the disease: Multiple Sclerosis Impact Scale (MSIS-29)
Biospecimen Retention: None Retained
|Study Start Date:||November 2010|
|Study Completion Date:||May 2012|
|Primary Completion Date:||April 2012 (Final data collection date for primary outcome measure)|
control group: no intervention
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)
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01492023
|Masku Neurological Rehabilitation Centre|
|Masku, Finland, 212521|
|Seinajoki Central Hospital|
|Seinäjoki, Finland, 60220|
|Tampere University Hospital|
|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|