Enhancing Sleep Dependent Consolidation by Non-invasive Brain Stimulation

NCT ID: NCT05843656

Last Updated: 2023-05-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-20

Study Completion Date

2022-03-19

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Stroke Aging

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

tDCS during sleep

Group Type EXPERIMENTAL

Non-invasive brain stimulation

Intervention Type OTHER

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

Spindle-like transcranial alternating current stimulation (tACS)

tACS during sleep

Group Type EXPERIMENTAL

Non-invasive brain stimulation

Intervention Type OTHER

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

Sham stimulation during sleep

Sham

Group Type SHAM_COMPARATOR

Non-invasive brain stimulation

Intervention Type OTHER

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

Wake in case participants could not take a nap

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

Group Type ACTIVE_COMPARATOR

Non-invasive brain stimulation

Intervention Type OTHER

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Non-invasive brain stimulation

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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
* 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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Friedhelm Hummel

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Friedhelm Hummel

Full Professor

Responsibility Role SPONSOR_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Campus Biotech

Geneva, , Switzerland

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Switzerland

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2017-00224

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.