- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01492023
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
연구 개요
상세 설명
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.
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
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Masku, 핀란드, 212521
- Masku Neurological Rehabilitation Centre
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Seinäjoki, 핀란드, 60220
- Seinäjoki Central Hospital
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Tampere, 핀란드
- Tampere University Hospital
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
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)
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
---|---|
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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Objective cognitive performance
기간: six months
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effects of rehabilitation on objective cognitive performance: SDMT
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six months
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Subjective cognitive performance
기간: 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
기간: six months
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Goal achievement: Goal Attainment Scaling (GAS)
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six months
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Quality of life
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
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공동 작업자 및 조사자
수사관
- 연구 책임자: Päivi I Hämäläinen, adjunct prof, Finnish MS Society / Masku Neurological Rehabilitation Centre
- 연구 의자: Keijo Koivisto, Prof, Seinäjoki Central Hospital
- 수석 연구원: Eija M Rosti-Otajärvi, PhD, Tampere University Hospital
- 수석 연구원: Anu Mäntynen, MA, Seinäjoki Central Hospital
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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