Multiple SclerosisMSattentionNCT01492023
The Effects of Attention Retraining in MS
An observational study of Multiple Sclerosis, run by Finnish MS Society at 3 sites in Finland.
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. Read more about this study
- Who is it for?
- Ages 18 to 58 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- neuropsychological rehabilitation
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 97 participants
- Where
- 3 sitesFinland
- Study dates
- Nov 2010to May 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 58 years
- All sexes
- No healthy volunteers
- Adult
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
Who may be able to join
- clinically definite MS
- EDSS < 6
- age 18-58 years
- subjective cognitive problems and objective decline in attention
Who cannot join
- other neurological disease than MS
- psychiatric diagnosis
- severe depression
- secondary progressive or primary progressive course of MS
- EDSS>=6
- alcohol or drug abuse
Show all 10Show fewer
- 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)
Trial locations and contacts
3 sites in 1 country.
Finland3 sites
Masku Neurological Rehabilitation Centre
Masku, 212521
Seinajoki Central Hospital
Seinäjoki, 60220
Tampere University Hospital
Tampere
About this study
Official title: The Effects of Attention Retraining on Cognitive Performance, QoL and Perceived Cognitive Impairment in MS - a Single Blind, Randomized, Controlled Study
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.
Read the 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.
- Conditions
- Multiple Sclerosis
- Being tested
- neuropsychological rehabilitation
- Keywords
- neuropsychological, rehabilitation, multiple sclerosis, RCT study
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
neuropsychological rehabilitationBehavioural
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)
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: neuropsychological rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective cognitive performance
effects of rehabilitation on objective cognitive performance: SDMT
Measured: six months
Subjective cognitive performance
The effects of rehabilitation on subjective cognitive performance: perceived cognitive deficits (Perceived Deficits Questionnaire, PDQ)
Measured: six months
Goal achievement
Goal achievement: Goal Attainment Scaling (GAS)
Measured: six months
Secondary outcomes (6)
Quality of life
The effects of rehabilitation on QoL: WHOQOL-Bref
Measured: six months
Objective cognitive performance
The effects of rehabilitation on cognitive performances: test of Brief Repeatable Battery of Neuropsychological Tests (BRBNT), Trail Making Test, Stroop test
Measured: six months
Mood
The effects of rehabilitation on mood: Beck Depression Inventory II (BDI II)
Measured: six months
Fatigue
The effects of rehabilitation on self-perceived feeling of fatigue: Fatigue Scale for Motor and Cognitive Fatigue (FSMC)
Measured: six months
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)
Measured: six months
The impact of the disease
The effects of rehabilitation on the impact of the disease: Multiple Sclerosis Impact Scale (MSIS-29)
Measured: six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2011 (estimated)
- Study startNov 2010
- Primary completionApr 2012
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- Finnish MS Society
- Sponsor type
- University, hospital or other
- Collaborators
- Social Insurance Institution, Finland, Tampere University Hospital, Seinajoki Central Hospital
- Responsible party
- Principal investigator, Paivi Hamalainen, Finnish MS Society
- Investigators
- Päivi I Hämäläinen, adjunct prof, Study director, Finnish MS Society / Masku Neurological Rehabilitation CentreKeijo Koivisto, Prof, Study chair, Seinajoki Central HospitalEija M Rosti-Otajärvi, PhD, Principal investigator, Tampere University HospitalAnu Mäntynen, MA, Principal investigator, Seinajoki Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01492023
- Sponsor's protocol ID
- MS1209
- Acronym
- MSattention
- Status last verified
- Mar 2013
- First submitted
- 4 Dec 2011
- Last updated
- 11 Mar 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Attention Retraining on Cognitive Performance, QoL and Perceived Cognitive Impairment in MS - a Single Blind, Randomized, Controlled Study
- ClinicalTrials.gov ID
- NCT01492023
- Acronym / sponsor ID
- MSattention / MS1209
- Conditions
- Multiple Sclerosis
- Keywords
- neuropsychological, rehabilitation, multiple sclerosis, RCT study
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- Finnish MS SocietyUniversity, hospital or other
- Collaborators
- Social Insurance Institution, Finland, Tampere University Hospital, Seinajoki Central Hospital
- Study start
- Nov 2010
- Primary completion
- Apr 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 14 Dec 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control | – | –control group: no intervention |
| neuropsychological rehabilitation | – | Behavioral: neuropsychological rehabilitationintervention group: neuropsychological rehabilitation (13 times 60 minutes, once per week, during 13 weeks) control group: no intervention |
Who may qualify
- Ages
- 18 to 58 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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
Key inclusion criteria (4 listed)
- clinically definite MS
- EDSS < 6
- age 18-58 years
- subjective cognitive problems and objective decline in attention
Key exclusion criteria (10 listed)
- other neurological disease than MS
- psychiatric diagnosis
- severe depression
- secondary progressive or primary progressive course of MS
- EDSS>=6
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| neuropsychological rehabilitationattention 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) | Behavioural | neuropsychological rehabilitation |
Primary outcome
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)
6 secondary outcomes
Quality of life
Time frame: six months
Objective cognitive performance
Time frame: six months
Mood
Time frame: six months
Fatigue
Time frame: six months
Subjective cognitive performance
Time frame: six months
The impact of the disease
Time frame: six months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2013.
Related trials for Multiple Sclerosis
RecruitingPhase 2
Metformin as an add-on or Monotherapy in Treatment of Aging People With Multiple Sclerosis (MS)
Multiple Sclerosis
RecruitingObservational study
Pain Phenotypes in Individuals With Multiple Sclerosis
Multiple Sclerosis, Chronic Pain
Not yet recruiting
Evaluating the Effect of the Zeen Mobility Device on Clinical Practicality, Safety, and Impact (Via Assessments of Walking, Standing Tolerance, Balance, Endurance, Effort, and Participation in Daily Tasks) in an Outpatient Rehabilitation Setting for Individuals With Mobility Impairments.
Stroke, Parkinson's Disease (PD)
RecruitingPhase 3
Dalfampridine Combined With Physical Therapy for Mobility Impairment in Multiple Sclerosis
Multiple Sclerosis
RecruitingPhase 2
Targeting Agonists of Glucagon-like Peptide-1 Receptor for Multiple Sclerosis
Multiple Sclerosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Päivi I Hämäläinen, adjunct prof study director
Finnish MS Society / Masku Neurological Rehabilitation Centre
Keijo Koivisto, Prof study chair
Seinajoki Central Hospital
Eija M Rosti-Otajärvi, PhD principal investigator
Tampere University Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis, run by Finnish MS Society at 3 sites in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective cognitive performance (time frame: six months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2013.