SleepNCT04714879
Modulation of Memory Consolidation in Humans
A study testing Device: anodal tDCS and Device: no stimulation in people with Sleep, run by University Medicine Greifswald at 1 site in Germany.
Trial summary
The goal of the present study is to optimize effects of slow oscillatory transcranial direct current stimulation (so-tDCS) on sleep physiology and memory consolidation in humans by combining computational and experimental human models in an iterative process. The investigator therefore works in cooperation with Prof. Read more about this study
- Who is it for?
- Ages 50 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep
- What is being tested?
- Device: anodal tDCS and Device: no stimulation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- 1 siteGermany
- Study dates
- 1 Dec 2018to 31 Jan 2021
- 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 50 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults aged between 50-80 years
- screened as healthy in a structured telephone interview
Who cannot join
- Mini Mental Status Examination scores below 24
- history of severe untreated medical, neurological, and psychiatric diseases
- sleep disorders
- alcohol or substance abuse
- brain pathologies identified on MRI scan
- intake of medication acting primarily on the central nervous system (e.g., antipsychotics, antidepressants, benzodiazepines, or any type of over-the-counter sleep-inducing drugs such as valerian),
- nonfluent German language abilities.
Trial locations and contacts
1 site in 1 country.
About this study
The goal of the present study is to optimize effects of slow oscillatory transcranial direct current stimulation (so-tDCS) on sleep physiology and memory consolidation in humans by combining computational and experimental human models in an iterative process. The investigator therefore works in cooperation with Prof. Dr. Klaus Obermayer (TU Berlin), who contributes computation models with the aim to mechanistically understand the impact of different perturbations on sleep-related electrophysiological features, and to subsequently optimize so-tDCS parameters for inducing SO and spindle activity.
Read the detailed description
Sleep plays an active role in long-term consolidation of memories. Specifically, slow oscillations (SO, large amplitude waves <1 Hz) and sleep spindles (8-15 Hz), that can be measured by electroencephalography (EEG), appear to be critical for declarative memories. According to the "active system consolidation" account, newly encoded memories are reactivated during sleep, accompanied by sharp-wave ripple events (80-100 Hz) in the hippocampus, and redistributed to cortical long-term storage networks through a coordinated dialog between the hippocampus and neocortex. This dialog is supposedly mediated by a particular coupling between cortical SO and thalamo-cortical fast spindles (12-15 Hz), with spindles preferably occurring during SO up-phases, and hippocampal ripples grouped at the troughs of fast spindles. Slow spindles (8-12 Hz) are a separate kind of sleep spindle activity whose function in memory consolidation is less well understood.
Interventions targeting sleep parameters may not only make it possible to beneficially modulate a vital aspect of memory consolidation, i. e., sleep-dependent memory consolidation, but may also help to delineate which specific elements of the neural dynamics during sleep are crucial for successful consolidation.
- Conditions
- Sleep
- Being tested
- Device: anodal tDCS, Device: no stimulation
- Keywords
- memory consolidation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Device: anodal tDCSOther
anodal current modulated by an oscillatory component including a fixed (0,75 Hz) versus individually adapted so-tDCS frequency with three different stimulation durations (5 min, 2 min, 30 sec)
Device: no stimulationOther
sham stimulation
| Study group | Role | What they receive |
|---|---|---|
| Slow oscillating transcranial direct current stimulation (so-tDCS) | Experimental | 7 experimental daytime naps with so-tDCS of different frequencies (fixed frequency of 0.75 Hz versus individually adapted frequency) and durations (5 min, 2 min, 30 sec) (Crossover assignment, applicable for each participant) Receives: Other: Device: anodal tDCS |
| Sham stimulation | Sham comparator | sham so-tDCS during a daytime nap (Crossover assignment, applicable for each participant) Receives: Other: Device: no stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in EEG power (μV²) of the slow oscillation frequency band (0.5-1 Hz) following so-tDCS during sleep
Investigation whether 7 different protocols of anodal tDCS (including SHAM) lead to distinct changes in slow oscillation power
Measured: up to 20 weeks
Changes in EEG power (μV²) of the sleep spindles frequency band (12-15 Hz) following so-tDCS during sleep
Investigation whether 7 different protocols of anodal tDCS (including SHAM) lead to distinct changes in sleep spindle power
Measured: up to 20 weeks
Changes in cross-frequency coupling (resultant vector length) between slow oscillations and sleep spindles following so-tDCS during sleep
Investigation whether 7 different protocols of anodal tDCS (including SHAM) lead to distinct changes in coupling between slow oscillations and sleep spindles
Measured: up to 20 weeks
Secondary outcomes (2)
Sleep architecture
Proportion of time spent in different sleep stages (in %) during the entire nap and following so-tDCS
Measured: up to 20 weeks
Changes in EEG power (μV²) of the delta frequency band (1-4 Hz) following so-tDCS during sleep
Investigation whether 7 different protocols of anodal tDCS (including SHAM) lead to distinct changes in delta power
Measured: up to 20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2021
- Study start1 Dec 2018
- Primary completion5 Jan 2021
- Study completion31 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SleepStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 7 experimental stimulation conditions (including sham stimulation) are tested in a randomized, counterbalanced, within-subject design
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medicine Greifswald
- Sponsor type
- University, hospital or other
- Collaborators
- Technische Universität Berlin
- Responsible party
- Sponsor
- Investigators
- Agnes Floeel, Prof., Study director, University Medicine Greifswald
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04714879
- Sponsor's protocol ID
- MemorySFB
- Status last verified
- Jun 2024
- First submitted
- 14 Dec 2018
- Last updated
- 11 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ladenbauer J, Khakimova L, Malinowski R, Obst D, Tonnies E, Antonenko D, Obermayer K, Hanna J, Floel A. Towards Optimization of Oscillatory Stimulation During Sleep. Neuromodulation. 2023 Dec;26(8):1592-1601. doi: 10.1016/j.neurom.2022.05.006. Epub 2022 Aug 16.
PubMed 35981956
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modulation of Memory Consolidation in Humans
- ClinicalTrials.gov ID
- NCT04714879
- Acronym / sponsor ID
- MemorySFB
- Conditions
- Sleep
- Keywords
- memory consolidation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- University Medicine GreifswaldUniversity, hospital or other
- Collaborators
- Technische Universität Berlin
- Study start
- 1 Dec 2018 (actual)
- Primary completion
- 5 Jan 2021 (actual)
- Study completion
- 31 Jan 2021 (actual)
- First posted
- 19 Jan 2021 (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.
The goal of the present study is to optimize effects of slow oscillatory transcranial direct current stimulation (so-tDCS) on sleep physiology and memory consolidation in humans by combining computational and experimental human models in an iterative process. The investigator therefore works in cooperation with Prof. Dr. Klaus Obermayer (TU Berlin), who contributes computation models with the aim to mechanistically understand the impact of different perturbations on sleep-related electrophysiological features, and to subsequently optimize so-tDCS parameters for inducing SO and spindle activity.
Detailed description
Sleep plays an active role in long-term consolidation of memories. Specifically, slow oscillations (SO, large amplitude waves <1 Hz) and sleep spindles (8-15 Hz), that can be measured by electroencephalography (EEG), appear to be critical for declarative memories. According to the "active system consolidation" account, newly encoded memories are reactivated during sleep, accompanied by sharp-wave ripple events (80-100 Hz) in the hippocampus, and redistributed to cortical long-term storage networks through a coordinated dialog between the hippocampus and neocortex. This dialog is supposedly mediated by a particular coupling between cortical SO and thalamo-cortical fast spindles (12-15 Hz), with spindles preferably occurring during SO up-phases, and hippocampal ripples grouped at the troughs of fast spindles. Slow spindles (8-12 Hz) are a separate kind of sleep spindle activity whose function in memory consolidation is less well understood.
Interventions targeting sleep parameters may not only make it possible to beneficially modulate a vital aspect of memory consolidation, i. e., sleep-dependent memory consolidation, but may also help to delineate which specific elements of the neural dynamics during sleep are crucial for successful consolidation.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- 7 experimental stimulation conditions (including sham stimulation) are tested in a randomized, counterbalanced, within-subject design
| Arm | Type | Receives |
|---|---|---|
| Slow oscillating transcranial direct current stimulation (so-tDCS) | Experimental | Other: Device: anodal tDCS7 experimental daytime naps with so-tDCS of different frequencies (fixed frequency of 0.75 Hz versus individually adapted frequency) and durations (5 min, 2 min, 30 sec) (Crossover assignment, applicable for each participant) |
| Sham stimulation | Sham comparator | Other: Device: no stimulationsham so-tDCS during a daytime nap (Crossover assignment, applicable for each participant) |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adults aged between 50-80 years
- screened as healthy in a structured telephone interview
Key exclusion criteria (7 listed)
- Mini Mental Status Examination scores below 24
- history of severe untreated medical, neurological, and psychiatric diseases
- sleep disorders
- alcohol or substance abuse
- brain pathologies identified on MRI scan
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 |
|---|---|---|
| Device: anodal tDCSanodal current modulated by an oscillatory component including a fixed (0,75 Hz) versus individually adapted so-tDCS frequency with three different stimulation durations (5 min, 2 min, 30 sec) | Other | Slow oscillating transcranial direct current stimulation (so-tDCS) |
| Device: no stimulationsham stimulation | Other | Sham stimulation |
Primary outcome
Changes in EEG power (μV²) of the slow oscillation frequency band (0.5-1 Hz) following so-tDCS during sleep
Time frame: up to 20 weeks
Investigation whether 7 different protocols of anodal tDCS (including SHAM) lead to distinct changes in slow oscillation power
Changes in EEG power (μV²) of the sleep spindles frequency band (12-15 Hz) following so-tDCS during sleep
Time frame: up to 20 weeks
Investigation whether 7 different protocols of anodal tDCS (including SHAM) lead to distinct changes in sleep spindle power
Changes in cross-frequency coupling (resultant vector length) between slow oscillations and sleep spindles following so-tDCS during sleep
Time frame: up to 20 weeks
Investigation whether 7 different protocols of anodal tDCS (including SHAM) lead to distinct changes in coupling between slow oscillations and sleep spindles
2 secondary outcomes
Sleep architecture
Time frame: up to 20 weeks
Changes in EEG power (μV²) of the delta frequency band (1-4 Hz) following so-tDCS during sleep
Time frame: up to 20 weeks
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 11 Jun 2024.
- Derived from this study: PubMed 35981956Ladenbauer J, Khakimova L, Malinowski R, Obst D, Tonnies E, Antonenko D, Obermayer K, Hanna J, Floel A. Towards Optimization of Oscillatory Stimulation During Sleep. Neuromodulation. 2023 Dec;26(8):1592-1601. doi: 10.1016/j.neurom.2022.05.006. Epub 2022 Aug 16.
- Individual participant dataSharing planned: No
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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.
Agnes Floeel, Prof. study director
University Medicine Greifswald
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Device: anodal tDCS and Device: no stimulation in people with Sleep, run by University Medicine Greifswald at 1 site in Germany.
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 2 inclusion and 7 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 11 Jun 2024. 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 Germany. 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?
Changes in EEG power (μV²) of the slow oscillation frequency band (0.5-1 Hz) following so-tDCS during sleep (time frame: up to 20 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04714879, which also lists 1 linked publication.
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 11 Jun 2024.