The Effects of Attention Retraining in MS

Multiple Sclerosis Clinical Trial

— MSattention  

Official title:

The Effects of Attention Retraining on Cognitive Performance, QoL and Perceived Cognitive Impairment in MS - a Single Blind, Randomized, Controlled Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01492023
• Other study ID #: MS1209
• Status: Completed
• Phase: N/A
• First received: December 4, 2011
• Last updated: March 8, 2013
• Start date: November 2010
• Est. completion date: May 2012

Study information

• Verified date: March 2013
• Source: Finnish MS Society
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: Ethics Committee
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 97
• Est. completion date: May 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 58 Years

Eligibility

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)

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Multiple Sclerosis

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)

Locations

Country	Name	City	State
Finland	Masku Neurological Rehabilitation Centre	Masku
Finland	Seinajoki Central Hospital	Seinäjoki
Finland	Tampere University Hospital	Tampere

Sponsors (4)

Lead Sponsor	Collaborator
Finnish MS Society	Seinajoki Central Hospital, Social Insurance Institution, Finland, Tampere University Hospital

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective cognitive performance	effects of rehabilitation on objective cognitive performance: SDMT	six months	No
Primary	Subjective cognitive performance	The effects of rehabilitation on subjective cognitive performance: perceived cognitive deficits (Perceived Deficits Questionnaire, PDQ)	six months	No
Primary	Goal achievement	Goal achievement: Goal Attainment Scaling (GAS)	six months	No
Secondary	Quality of life	The effects of rehabilitation on QoL: WHOQOL-Bref	six months	No
Secondary	Objective cognitive performance	The effects of rehabilitation on cognitive performances: test of Brief Repeatable Battery of Neuropsychological Tests (BRBNT), Trail Making Test, Stroop test	six months	No
Secondary	Mood	The effects of rehabilitation on mood: Beck Depression Inventory II (BDI II)	six months	No
Secondary	Fatigue	The effects of rehabilitation on self-perceived feeling of fatigue: Fatigue Scale for Motor and Cognitive Fatigue (FSMC)	six months	No
Secondary	Subjective cognitive performance	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)	six months	No
Secondary	The impact of the disease	The effects of rehabilitation on the impact of the disease: Multiple Sclerosis Impact Scale (MSIS-29)	six months	No