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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04714879
Other study ID # MemorySFB
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 1, 2018
Est. completion date January 31, 2021

Study information

Verified date June 2024
Source University Medicine Greifswald
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 54
Est. completion date January 31, 2021
Est. primary completion date January 5, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 50 Years to 80 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Device: anodal tDCS
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 stimulation
sham stimulation

Locations

Country Name City State
Germany University medicine Greifswald Greifswald

Sponsors (2)

Lead Sponsor Collaborator
University Medicine Greifswald Technische Universität Berlin

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 up to 20 weeks
Primary 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 up to 20 weeks
Primary 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 up to 20 weeks
Secondary Sleep architecture Proportion of time spent in different sleep stages (in %) during the entire nap and following so-tDCS up to 20 weeks
Secondary 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 up to 20 weeks
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