E-ConS: Enhancing Sleep Dependent Consolidation by Non-invasive Brain Stimulation

Sponsor
Friedhelm Hummel (Other)
Overall Status
Completed
CT.gov ID
NCT05843656
Collaborator
(none)
62
1
4
36
1.7

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Non-invasive brain stimulation
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
62 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Basic Science
Official Title:
Enhancing Sleep Dependent Consolidation by Non-invasive Brain Stimulation to Boost Motor Skill Acquisition in Individuals After Stroke
Actual Study Start Date :
Mar 20, 2019
Actual Primary Completion Date :
Jan 18, 2022
Actual Study Completion Date :
Mar 19, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Slow-wave-like transcranial direct current stimulation (tDCS)

tDCS during sleep

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

Experimental: Spindle-like transcranial alternating current stimulation (tACS)

tACS during sleep

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

Sham Comparator: Sham stimulation during sleep

Sham

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

Active Comparator: Wake in case participants could not take a nap

Active Comparator (with stimulation), in case participants could not take a nap

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

Outcome Measures

Primary Outcome Measures

  1. Behavioural motor score (session 1) [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) [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) [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) [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 Outcome Measures

  1. Behavioural motor score (session 5) [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 [15 minutes]

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

  3. Electroencephalography (EEG) during sleep [1 hour]

    Sleep spindle density (spindle per minute)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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)

Contacts and Locations

Locations

Site City State Country Postal Code
1 Campus Biotech Geneva Switzerland 1202

Sponsors and Collaborators

  • Friedhelm Hummel

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Friedhelm Hummel, Full Professor, Ecole Polytechnique Fédérale de Lausanne
ClinicalTrials.gov Identifier:
NCT05843656
Other Study ID Numbers:
  • 2017-00224
First Posted:
May 6, 2023
Last Update Posted:
May 6, 2023
Last Verified:
Apr 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 6, 2023