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

Primary Purpose

Stroke, Aging

Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Non-invasive brain stimulation
Sponsored by
Friedhelm Hummel
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Stroke

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • Campus Biotech

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Sham Comparator

Active Comparator

Arm Label

Slow-wave-like transcranial direct current stimulation (tDCS)

Spindle-like transcranial alternating current stimulation (tACS)

Sham stimulation during sleep

Wake in case participants could not take a nap

Arm Description

tDCS during sleep

tACS during sleep

Sham

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

Outcomes

Primary Outcome Measures

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
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
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
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

Secondary Outcome Measures

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
Functional magnetic resonance imaging (fMRI) during behavioral motor score evaluation
Blood oxygen level dependent contrast among sessions (sessions 1-5)
Electroencephalography (EEG) during sleep
Sleep spindle density (spindle per minute)

Full Information

First Posted
March 13, 2023
Last Updated
April 24, 2023
Sponsor
Friedhelm Hummel
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1. Study Identification

Unique Protocol Identification Number
NCT05843656
Brief Title
Enhancing Sleep Dependent Consolidation by Non-invasive Brain Stimulation
Acronym
E-ConS
Official Title
Enhancing Sleep Dependent Consolidation by Non-invasive Brain Stimulation to Boost Motor Skill Acquisition in Individuals After Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
March 20, 2019 (Actual)
Primary Completion Date
January 18, 2022 (Actual)
Study Completion Date
March 19, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Friedhelm Hummel

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Aging

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
62 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Slow-wave-like transcranial direct current stimulation (tDCS)
Arm Type
Experimental
Arm Description
tDCS during sleep
Arm Title
Spindle-like transcranial alternating current stimulation (tACS)
Arm Type
Experimental
Arm Description
tACS during sleep
Arm Title
Sham stimulation during sleep
Arm Type
Sham Comparator
Arm Description
Sham
Arm Title
Wake in case participants could not take a nap
Arm Type
Active Comparator
Arm Description
Active Comparator (with stimulation), in case participants could not take a nap
Intervention Type
Other
Intervention Name(s)
Non-invasive brain stimulation
Intervention Description
based on sleep-physiology (slow-wave and spindles)
Primary Outcome Measure Information:
Title
Behavioural motor score (session 1)
Description
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
Time Frame
15 minutes
Title
Behavioural motor score (session 2)
Description
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
Time Frame
15 minutes
Title
Behavioural motor score (session 3)
Description
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
Time Frame
15 minutes
Title
Behavioural motor score (session 4)
Description
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
Time Frame
15 minutes
Secondary Outcome Measure Information:
Title
Behavioural motor score (session 5)
Description
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
Time Frame
15 minutes
Title
Functional magnetic resonance imaging (fMRI) during behavioral motor score evaluation
Description
Blood oxygen level dependent contrast among sessions (sessions 1-5)
Time Frame
15 minutes
Title
Electroencephalography (EEG) during sleep
Description
Sleep spindle density (spindle per minute)
Time Frame
1 hour

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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)
Facility Information:
Facility Name
Campus Biotech
City
Geneva
ZIP/Postal Code
1202
Country
Switzerland

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
Data can be provided/shared upon reasonable request

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Enhancing Sleep Dependent Consolidation by Non-invasive Brain Stimulation

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