Clinical trial NCT05843656: Enhancing Sleep Dependent Consolidation by Non-invasive Brain Stimulation
Official title: Enhancing Sleep Dependent Consolidation by Non-invasive Brain Stimulation to Boost Motor Skill Acquisition in Individuals After Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Aging
Lead sponsor: Ecole Polytechnique Fédérale de Lausanne
Sponsor class: OTHER
First posted: 2023-05-06
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Stroke, one of the most common causes for acquired adult disability, is not only a burden for the individual but also for his or her close relatives and caregivers. Functional recovery is commonly associated with the re-acquisition of lost skills. This skill (re-)acquisition is separated into different phases during which learning takes place while the skill/movement is actively performed - so called online learning - or during the time of non-performance between the training - so called offline learning or consolidation. During the initial phase of training, performance improvements are commonly steep (online learning). During the following processes of consolidation, which often depend on sleep, memory traces are being modified and stored for long-term memory retention leading to a further improvement without additional training (offline learning). Previous studies focusing on individuals after stroke could show a beneficial effect of sleep on motor skill acquisition. As an intervention, transcranial electrical stimulation (tES) with motor tasks could show beneficial effects on motor skill acquisition. tES is a method to stimulate an area of the brain non-invasively and this is done by applying low voltage current to the scalp that lies in close proximity to the target brain region. In the current study, stimulation is performed during sleep and types of stimulation resemble natural sleep physiology: slow-wave and spindles. As slow-wave and spindles are shown to be important for memory consolidation, it is hypothesized that applying physiologically-inspired stimulation could enhance memory consolidation in individuals after stroke. It is known that patterns of sleep physiology change in older individuals, thus, this population is also investigated in the current study. It is interpreted and discussed that older individuals do not benefit from sleep as much as younger individuals do. Thus, it is hypothesized that applying physiologically-inspired stimulation could enhance memory consolidation in healthy older individuals.


Eligibility criteria: Inclusion Criteria:

* right handed (healthy older)
* healthy (healthy older)
* monohemispheric stroke (individuals after stroke)
* at least 6 months since diagnosis stroke (individuals after stroke)

Exclusion Criteria:

* Unable to provide informed consent
* Pregnancy
* Known or suspected non-compliance, drug or alcohol abuse
* Inability to follow the procedures of the study, e.g., due to language problems, psychological disorders, dementia, etc. of the participant
* Non-compliance to the instructions of the experimenter or an inappropriate behaviour hindering the normal progress of the experiment
* Previous enrolment into the current study
* Exclusion criteria tES, and transcranial magnetic stimulation (TMS)
* Use of psychoactive medication, which might influence the study results
* Request of not being informed in case of incidental findings
* Recurrent stroke / multiple strokes (individuals after stroke)
* Cerebellar stroke (individuals after stroke)

Primary outcomes:
measure: Behavioural motor score (session 1)
timeFrame: 15 minutes
measure: Behavioural motor score (session 2)
timeFrame: 15 minutes
measure: Behavioural motor score (session 3)
timeFrame: 15 minutes
measure: Behavioural motor score (session 4)
timeFrame: 15 minutes
Secondary outcomes:
measure: Behavioural motor score (session 5)
timeFrame: 15 minutes
measure: Functional magnetic resonance imaging (fMRI) during behavioral motor score evaluation
timeFrame: 15 minutes
measure: Electroencephalography (EEG) during sleep
timeFrame: 1 hour
Other outcomes:
Locations:
city: Geneva
country: Switzerland
facility: Campus Biotech
Study officials:
References: