Cognitive Training After Stroke : Effects and Mechanisms
Kognitiv Trening Etter Hjerneslag: Effekter og Mekanismer #2015/1282
Stroke is a major cause of severe cognitive and physical disability. Despite the high and increasing incidence, and large health, economic, social and personal consequences, studies designed to remedy cognitive impairments and improve rehabilitation care following stroke are lacking. A promising line of research have shown that weak electrical current (tDCS) can be a safe, cost-effective, and potent treatment when combined with other rehablitational approaches.
The underlying mechanism is assumed that tDCS facilitates neuronal signaling, improving plasticity and facilitating rehablitational outcome. But further research is needed to better understand the mechanisms at hand, and to better evaluate the potential clinical utility.
The scope for the current project is to investigate both cognitive and neuronal effects of tDCS in combination with cognitive training , with the ultimate goal to improve current rehabilitational healthcare. To achieve this we will use multimodal MRI, EEG, and a comprehensive battery of neuropsychological asessment, to describe and evaluate the effect of tDCS in rehabilitation purposes.
연구 개요
상세 설명
Participants are randomly assigned to either active or sham condition, using codes provided by the manufacturer and implemented by an in-house Matlab script, pseudo-randomizing participants while maintaining balance in groups of 20. tDCS stimulation is applied at six occasions for each participant, with a minimum of 48 hours between stimulations, aiming at an average of two stimulations per week. Stimulation current is1000 μA, stimulation time was 20 min for the active group with a ramp-up time of 120 s and fade-out time of 30 s. The current intensity is limited to 1 mA to limit the risk of adverse events due to the electrical stimulation. The sham stimulation consists of ramp-up followed by 40 s of active stimulation and then fade-out, following factory settings.
Cognitive training will be done by the computerized working memory training program (Cogmed Systems AB, Stockholm, Sweden) consisting of 25 online training sessions. In this study, to increase feasibility, we utilize 17 sessions over a period of three to four weeks, corresponding to approximately five weekly training sessions. On average, we aim at two training sessions combined with tDCS per week with a minimum of one day between each tDCS session. The remaining CCT sessions are performed at home.
Neuropsychological assessments and MRI assessments are conducted three times: at baseline 1, after a waiting period of 2-4 weeks (baseline 2, before intervention) and immediately post intervention. Self-reported symptoms of fatigue and depression are assessed at five time points, before, during and after completing intervention.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Oslo, 노르웨이
- Oslo University Hospital
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Oslo, 노르웨이
- Oslo University Hospital Ullevål
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- MR/CT revealing ischemic or hemorrhagic damage (stroke).
Exclusion Criteria:
- History of illness or damage to the CNS, besides stroke.
- <18 years of age
- Extensive cognitive decline or dementia
- Severe psychiatric disorders
- Substance or alcohol abuse
- Contraindications for MRI.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 삼루타
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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활성 비교기: Active stimulation
Participants recieving active trancranial direct current stimulation (tDCS) Parameters: 20 minutes anodal tDCS 1mA.
Two times a week, for three weeks.
Anode placed at F3, cathode placed at right cerebellum.
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위약 비교기: Sham stimulation
Participants recieving passive / sham trancranial direct current stimulation (tDCS) Two times a week, for three weeks.
Anode placed at F3, cathode placed at right cerebellum.
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Sham Transcranial direct current stimulation (tDCS)
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Evidence of change in neural activity in attentional-related brain areas after receiving anodal tDCS, as measured with functional MRI
기간: One and a half year
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Change in activation patterns during multiple object tracking (MOT) at first baseline, before initiating training (second baseline, on average 4 weeks after baseline measure), and after a three-week intervention (post-intervention assessment)
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One and a half year
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Evidence of structural changes after receiving anodal tDCS, as measured with structural MRI
기간: One and a half year
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Structural MRI
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One and a half year
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Evidence of increased attentional and working memory capacity after receiving anodal tDCS
기간: One and a half year
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Rate of improvement in Cogmed tasks
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One and a half year
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Evidence of increased attentional capacity after receiving anodal tDCS
기간: One and a half year
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Performance change in The Theory of Visual Attention (TVA) computerized paradigm.
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One and a half year
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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Evidence of change in fatigue severity after receiving tDCS
기간: One and a half year
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Fatigue Severity Scale (FSS), a seven-point Likert scale on subjective fatigue severity/impact.
9 items scored from 1 (less symptoms) to 7 (most severe symptoms).
Scores are reported as mean scores, lowest possible mean = 1, highest possible mean = 7.
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One and a half year
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Evidence of change in symptoms of depression after receiving tDCS
기간: One and a half year
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Patient Health Questionnaire (PHQ-9), self-reported depressive symptoms.
Scale consists of 9 items, scored from 0 (not at all) to 3 (nearly every day).
Scores are reported as sum scores, range 0 (less symptoms) - 27 (more symptoms)
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One and a half year
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공동 작업자 및 조사자
수사관
- 연구 책임자: Lars T. Westlye, Ph.D, University of Oslo
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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