- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04714879
Modulation of Memory Consolidation in Humans
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Greifswald, Germany, 17475
- University Medicine Greifswald
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Adults aged between 50-80 years
- screened as healthy in a structured telephone interview
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Slow oscillating transcranial direct current stimulation (so-tDCS)
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)
|
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)
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Sham Comparator: Sham stimulation
sham so-tDCS during a daytime nap (Crossover assignment, applicable for each participant)
|
sham stimulation
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
up to 20 weeks
|
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
|
up to 20 weeks
|
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
|
up to 20 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Sleep architecture
Time Frame: up to 20 weeks
|
Proportion of time spent in different sleep stages (in %) during the entire nap and following so-tDCS
|
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
|
Investigation whether 7 different protocols of anodal tDCS (including SHAM) lead to distinct changes in delta power
|
up to 20 weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: Agnes Floeel, Prof., University Medicine Greifswald
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- MemorySFB
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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