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Completed

NCT Number: NCT04932304

Cognitive Training After Stroke : Effects and Mechanisms

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.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Oslo University Hospital, Oslo, Norway

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Transcranial direct current stimulation (tDCS)

Device

Sham Transcranial Direct Current Stimulation (tDCS)

Device

Sham Transcranial direct current stimulation (tDCS)

Primary outcomes

  1. Evidence of change in neural activity in attentional-related brain areas after receiving anodal tDCS, as measured with functional MRI

    Time frame: One and a half year

    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)

  2. Evidence of structural changes after receiving anodal tDCS, as measured with structural MRI

    Time frame: One and a half year

    Structural MRI

  3. Evidence of increased attentional and working memory capacity after receiving anodal tDCS

    Time frame: One and a half year

    Rate of improvement in Cogmed tasks

Secondary outcomes

  1. Evidence of increased attentional capacity after receiving anodal tDCS

    Time frame: One and a half year

    Performance change in The Theory of Visual Attention (TVA) computerized paradigm.

Other outcomes

  1. Evidence of change in fatigue severity after receiving tDCS

    Time frame: One and a half year

    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.

  2. Evidence of change in symptoms of depression after receiving tDCS

    Time frame: One and a half year

    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)

Sponsors and collaborators

Lead sponsor

Oslo University Hospital

Other

Registry information

Official study title

Kognitiv Trening Etter Hjerneslag: Effekter og Mekanismer #2015/1282

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jun 21, 2021
Registry last updated
Jun 21, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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