The Effects of Attention Retraining in MS (MSattention)
The Effects of Attention Retraining on Cognitive Performance, QoL and Perceived Cognitive Impairment in MS - a Single Blind, Randomized, Controlled Study
調査の概要
詳細な説明
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.
研究の種類
入学 (実際)
連絡先と場所
研究場所
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-
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Masku、フィンランド、212521
- Masku Neurological Rehabilitation Centre
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Seinäjoki、フィンランド、60220
- Seinäjoki Central Hospital
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Tampere、フィンランド
- Tampere University Hospital
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
説明
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)
研究計画
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
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control
control group: no intervention
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neuropsychological rehabilitation
intervention group: neuropsychological rehabilitation (13 times 60 minutes, once per week, during 13 weeks) control group: no intervention
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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)
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Objective cognitive performance
時間枠：six months
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effects of rehabilitation on objective cognitive performance: SDMT
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six months
|
|
Subjective cognitive performance
時間枠：six months
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The effects of rehabilitation on subjective cognitive performance: perceived cognitive deficits (Perceived Deficits Questionnaire, PDQ)
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six months
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Goal achievement
時間枠：six months
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Goal achievement: Goal Attainment Scaling (GAS)
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six months
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Quality of life
時間枠：six months
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The effects of rehabilitation on QoL: WHOQOL-Bref
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six months
|
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Objective cognitive performance
時間枠：six months
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The effects of rehabilitation on cognitive performances: test of Brief Repeatable Battery of Neuropsychological Tests (BRBNT), Trail Making Test, Stroop test
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six months
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Mood
時間枠：six months
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The effects of rehabilitation on mood: Beck Depression Inventory II (BDI II)
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six months
|
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Fatigue
時間枠：six months
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The effects of rehabilitation on self-perceived feeling of fatigue: Fatigue Scale for Motor and Cognitive Fatigue (FSMC)
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six months
|
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Subjective cognitive performance
時間枠：six months
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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)
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six months
|
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The impact of the disease
時間枠：six months
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The effects of rehabilitation on the impact of the disease: Multiple Sclerosis Impact Scale (MSIS-29)
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six months
|
協力者と研究者
スポンサー
捜査官
- スタディディレクター：Päivi I Hämäläinen, adjunct prof、Finnish MS Society / Masku Neurological Rehabilitation Centre
- スタディチェア：Keijo Koivisto, Prof、Seinäjoki Central Hospital
- 主任研究者：Eija M Rosti-Otajärvi, PhD、Tampere University Hospital
- 主任研究者：Anu Mäntynen, MA、Seinäjoki Central Hospital
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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