Enhancing Sleep Dependent Consolidation by Non-invasive Brain Stimulation

Stroke Clinical Trial

— E-ConS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05843656
• Other study ID #: 2017-00224
• Status: Completed
• Phase: N/A
• Start date: March 20, 2019
• Est. completion date: March 19, 2022

Study information

• Verified date: April 2023
• Source: Ecole Polytechnique Fédérale de Lausanne
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: March 19, 2022
• Est. primary completion date: January 18, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Aging
• Stroke

Intervention

Other:
• Non-invasive brain stimulation
based on sleep-physiology (slow-wave and spindles)

Locations

Country	Name	City	State
Switzerland	Campus Biotech	Geneva

Sponsors (1)

Lead Sponsor	Collaborator
Friedhelm Hummel

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Behavioural motor score (session 1)	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	15 minutes
Primary	Behavioural motor score (session 2)	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	15 minutes
Primary	Behavioural motor score (session 3)	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	15 minutes
Primary	Behavioural motor score (session 4)	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	15 minutes
Secondary	Behavioural motor score (session 5)	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	15 minutes
Secondary	Functional magnetic resonance imaging (fMRI) during behavioral motor score evaluation	Blood oxygen level dependent contrast among sessions (sessions 1-5)	15 minutes
Secondary	Electroencephalography (EEG) during sleep	Sleep spindle density (spindle per minute)	1 hour