Cognitive Training After Stroke : Effects and Mechanisms
Primary Purpose
Stroke
Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Transcranial direct current stimulation (tDCS)
Sham Transcranial direct current stimulation (tDCS)
Sponsored by

About this trial
This is an interventional treatment trial for Stroke
Eligibility Criteria
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.
Sites / Locations
- Oslo University Hospital Ullevål
- Oslo University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Active stimulation
Sham stimulation
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Evidence of change in neural activity in attentional-related brain areas after receiving anodal tDCS, as measured with functional MRI
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)
Evidence of structural changes after receiving anodal tDCS, as measured with structural MRI
Structural MRI
Evidence of increased attentional and working memory capacity after receiving anodal tDCS
Rate of improvement in Cogmed tasks
Secondary Outcome Measures
Evidence of increased attentional capacity after receiving anodal tDCS
Performance change in The Theory of Visual Attention (TVA) computerized paradigm.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04932304
Brief Title
Cognitive Training After Stroke : Effects and Mechanisms
Official Title
Kognitiv Trening Etter Hjerneslag: Effekter og Mekanismer #2015/1282
Study Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
May 2016 (Actual)
Primary Completion Date
December 20, 2017 (Actual)
Study Completion Date
December 20, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oslo University Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
54 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Active stimulation
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Sham stimulation
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Transcranial direct current stimulation (tDCS)
Intervention Type
Device
Intervention Name(s)
Sham Transcranial direct current stimulation (tDCS)
Intervention Description
Sham Transcranial direct current stimulation (tDCS)
Primary Outcome Measure Information:
Title
Evidence of change in neural activity in attentional-related brain areas after receiving anodal tDCS, as measured with functional MRI
Description
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)
Time Frame
One and a half year
Title
Evidence of structural changes after receiving anodal tDCS, as measured with structural MRI
Description
Structural MRI
Time Frame
One and a half year
Title
Evidence of increased attentional and working memory capacity after receiving anodal tDCS
Description
Rate of improvement in Cogmed tasks
Time Frame
One and a half year
Secondary Outcome Measure Information:
Title
Evidence of increased attentional capacity after receiving anodal tDCS
Description
Performance change in The Theory of Visual Attention (TVA) computerized paradigm.
Time Frame
One and a half year
Other Pre-specified Outcome Measures:
Title
Evidence of change in fatigue severity after receiving tDCS
Description
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.
Time Frame
One and a half year
Title
Evidence of change in symptoms of depression after receiving tDCS
Description
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)
Time Frame
One and a half year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lars T. Westlye, Ph.D
Organizational Affiliation
University of Oslo
Official's Role
Study Director
Facility Information:
Facility Name
Oslo University Hospital Ullevål
City
Oslo
Country
Norway
Facility Name
Oslo University Hospital
City
Oslo
Country
Norway
12. IPD Sharing Statement
Learn more about this trial
Cognitive Training After Stroke : Effects and Mechanisms
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