Clinical trial NCT04932304: Cognitive Training After Stroke : Effects and Mechanisms
Official title: Kognitiv Trening Etter Hjerneslag: Effekter og Mekanismer #2015/1282
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
First posted: 2021-06-21
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Evidence of change in neural activity in attentional-related brain areas after receiving anodal tDCS, as measured with functional MRI
timeFrame: One and a half year
measure: Evidence of structural changes after receiving anodal tDCS, as measured with structural MRI
timeFrame: One and a half year
measure: Evidence of increased attentional and working memory capacity after receiving anodal tDCS
timeFrame: One and a half year
Secondary outcomes:
measure: Evidence of increased attentional capacity after receiving anodal tDCS
timeFrame: One and a half year
Other outcomes:
measure: Evidence of change in fatigue severity after receiving tDCS
timeFrame: One and a half year
measure: Evidence of change in symptoms of depression after receiving tDCS
timeFrame: One and a half year
Locations:
city: Oslo
country: Norway
facility: Oslo University Hospital Ullevål
city: Oslo
country: Norway
facility: Oslo University Hospital
Study officials:
affiliation: University of Oslo
name: Lars T. Westlye, Ph.D
role: STUDY_DIRECTOR
References: