Multiple Sclerosis
Conditions
Keywords
neuropsychological, rehabilitation, multiple sclerosis, RCT study
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.
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.
Interventions
BEHAVIORALneuropsychological 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)
Sponsors
Social Insurance Institution, Finland
Tampere University Hospital
Seinajoki Central Hospital
Finnish MS Society
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 58 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective cognitive performance | six months | effects of rehabilitation on objective cognitive performance: SDMT |
| Subjective cognitive performance | six months | The effects of rehabilitation on subjective cognitive performance: perceived cognitive deficits (Perceived Deficits Questionnaire, PDQ) |
| Goal achievement | six months | Goal achievement: Goal Attainment Scaling (GAS) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fatigue | six months | The effects of rehabilitation on self-perceived feeling of fatigue: Fatigue Scale for Motor and Cognitive Fatigue (FSMC) |
| Quality of life | six months | The effects of rehabilitation on QoL: WHOQOL-Bref |
| The impact of the disease | six months | The effects of rehabilitation on the impact of the disease: Multiple Sclerosis Impact Scale (MSIS-29) |
| Subjective cognitive performance | 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) |
| Objective cognitive performance | six months | The effects of rehabilitation on cognitive performances: test of Brief Repeatable Battery of Neuropsychological Tests (BRBNT), Trail Making Test, Stroop test |
| Mood | six months | The effects of rehabilitation on mood: Beck Depression Inventory II (BDI II) |
Countries
Finland
Outcome results
None listed