Modulation of Memory Consolidation in Humans

October 14, 2021 updated by: University Medicine Greifswald
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.

Study Overview

Status

Active, not recruiting

Conditions

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

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Greifswald, Germany, 17475
        • University Medicine Greifswald

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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)
Sham Comparator: Sham stimulation
sham so-tDCS during a daytime nap (Crossover assignment, applicable for each participant)
sham stimulation

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

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Agnes Floeel, Prof., University Medicine Greifswald

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2018

Primary Completion (Anticipated)

March 3, 2022

Study Completion (Anticipated)

March 31, 2022

Study Registration Dates

First Submitted

December 14, 2018

First Submitted That Met QC Criteria

January 15, 2021

First Posted (Actual)

January 19, 2021

Study Record Updates

Last Update Posted (Actual)

October 15, 2021

Last Update Submitted That Met QC Criteria

October 14, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • MemorySFB

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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