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Completed

NCT Number: NCT05843656

Enhancing Sleep Dependent Consolidation by Non-invasive Brain Stimulation

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Campus Biotech

Geneva, 1202, Switzerland

Who can participate

Healthy volunteers accepted: Yes

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

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)

Treatment and study plan

Non-invasive brain stimulation

Other

based on sleep-physiology (slow-wave and spindles)

Primary outcomes

  1. Behavioural motor score (session 1)

    Time frame: 15 minutes

    It is a computer-based score, which determines (compound) measure of accuracy and speed and can therefore be seen as a measure of performance improvement at session 1

  2. Behavioural motor score (session 2)

    Time frame: 15 minutes

    It is a computer-based score, which determines (compound) measure of accuracy and speed and can therefore be seen as a measure of performance improvement at session 2

  3. Behavioural motor score (session 3)

    Time frame: 15 minutes

    It is a computer-based score, which determines (compound) measure of accuracy and speed and can therefore be seen as a measure of performance improvement at session 3

  4. Behavioural motor score (session 4)

    Time frame: 15 minutes

    It is a computer-based score, which determines (compound) measure of accuracy and speed and can therefore be seen as a measure of performance improvement at session 4

Secondary outcomes

  1. Behavioural motor score (session 5)

    Time frame: 15 minutes

    It is a computer-based score, which determines (compound) measure of accuracy and speed and can therefore be seen as a measure of performance improvement at session 5

  2. Functional magnetic resonance imaging (fMRI) during behavioral motor score evaluation

    Time frame: 15 minutes

    Blood oxygen level dependent contrast among sessions (sessions 1-5)

  3. Electroencephalography (EEG) during sleep

    Time frame: 1 hour

    Sleep spindle density (spindle per minute)

Sponsors and collaborators

Lead sponsor

Friedhelm Hummel

Other

Registry information

Official study title

Enhancing Sleep Dependent Consolidation by Non-invasive Brain Stimulation to Boost Motor Skill Acquisition in Individuals After Stroke

Acronym: E-ConS

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
May 6, 2023
Registry last updated
May 6, 2023

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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