StrokeE-ConSNCT05843656
Enhancing Sleep Dependent Consolidation by Non-invasive Brain Stimulation
A study testing Non-invasive brain stimulation in people with Stroke and Aging, run by Friedhelm Hummel at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- What is being tested?
- Non-invasive brain stimulation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 62 participants
- Where
- 1 siteSwitzerland
- Study dates
- 20 Mar 2019to 19 Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- right handed (healthy older)
- healthy (healthy older)
- monohemispheric stroke (individuals after stroke)
- at least 6 months since diagnosis stroke (individuals after stroke)
Who cannot join
- 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
Show all 11Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Enhancing Sleep Dependent Consolidation by Non-invasive Brain Stimulation to Boost Motor Skill Acquisition in Individuals After Stroke
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.
- Being tested
- Non-invasive brain stimulation
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-invasive brain stimulationOther
based on sleep-physiology (slow-wave and spindles)
| Study group | Role | What they receive |
|---|---|---|
| Slow-wave-like transcranial direct current stimulation (tDCS) | Experimental | tDCS during sleep Receives: Other: Non-invasive brain stimulation |
| Spindle-like transcranial alternating current stimulation (tACS) | Experimental | tACS during sleep Receives: Other: Non-invasive brain stimulation |
| Sham stimulation during sleep | Sham comparator | Sham Receives: Other: Non-invasive brain stimulation |
| Wake in case participants could not take a nap | Active comparator | Active Comparator (with stimulation), in case participants could not take a nap Receives: Other: Non-invasive brain stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 15 minutes
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
Measured: 15 minutes
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
Measured: 15 minutes
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
Measured: 15 minutes
Secondary outcomes (3)
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
Measured: 15 minutes
Functional magnetic resonance imaging (fMRI) during behavioral motor score evaluation
Blood oxygen level dependent contrast among sessions (sessions 1-5)
Measured: 15 minutes
Electroencephalography (EEG) during sleep
Sleep spindle density (spindle per minute)
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2023
- Study start20 Mar 2019
- Primary completion18 Jan 2022
- Study completion19 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Friedhelm Hummel
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Friedhelm Hummel, Ecole Polytechnique Fédérale de Lausanne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05843656
- Sponsor's protocol ID
- 2017-00224
- Other IDs
- 2017
- Acronym
- E-ConS
- Status last verified
- Apr 2023
- First submitted
- 13 Mar 2023
- Last updated
- 6 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Data can be provided/shared upon reasonable request
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Sleep Dependent Consolidation by Non-invasive Brain Stimulation to Boost Motor Skill Acquisition in Individuals After Stroke
- ClinicalTrials.gov ID
- NCT05843656
- Acronym / sponsor ID
- E-ConS / 2017-00224
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Friedhelm HummelUniversity, hospital or other
- Study start
- 20 Mar 2019 (actual)
- Primary completion
- 18 Jan 2022 (actual)
- Study completion
- 19 Mar 2022 (actual)
- First posted
- 6 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Slow-wave-like transcranial direct current stimulation (tDCS) | Experimental | Other: Non-invasive brain stimulationtDCS during sleep |
| Spindle-like transcranial alternating current stimulation (tACS) | Experimental | Other: Non-invasive brain stimulationtACS during sleep |
| Sham stimulation during sleep | Sham comparator | Other: Non-invasive brain stimulationSham |
| Wake in case participants could not take a nap | Active comparator | Other: Non-invasive brain stimulationActive Comparator (with stimulation), in case participants could not take a nap |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- right handed (healthy older)
- healthy (healthy older)
- monohemispheric stroke (individuals after stroke)
- at least 6 months since diagnosis stroke (individuals after stroke)
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-invasive brain stimulationbased on sleep-physiology (slow-wave and spindles) | Other | Sham stimulation during sleep, Slow-wave-like transcranial direct current stimulation (tDCS), Spindle-like transcranial alternating current stimulation (tACS), Wake in case participants could not take a nap |
Primary outcome
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
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
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
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
3 secondary outcomes
Behavioural motor score (session 5)
Time frame: 15 minutes
Functional magnetic resonance imaging (fMRI) during behavioral motor score evaluation
Time frame: 15 minutes
Electroencephalography (EEG) during sleep
Time frame: 1 hour
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2023.
- Individual participant dataSharing planned: Undecided. Data can be provided/shared upon reasonable request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non-invasive brain stimulation in people with Stroke and Aging, run by Friedhelm Hummel at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Behavioural motor score (session 1) (time frame: 15 minutes). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2023.