Modulation of Memory Consolidation in Humans

NCT04714879 | Completed

• 1 other identifier: MemorySFB
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Sleep

Keywords

memory consolidation

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (2)

• Sleep architecture

  up to 20 weeks

• Changes in EEG power (μV²) of the delta frequency band (1-4 Hz) following so-tDCS during sleep

  up to 20 weeks

Study Arms (2)

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)

Other: Device: anodal tDCS

Sham stimulation

SHAM COMPARATOR

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

Other: Device: no stimulation

Interventions

Device: anodal tDCS OTHER

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)

Slow oscillating transcranial direct current stimulation (so-tDCS)

Device: no stimulation OTHER

sham stimulation

Sham stimulation

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged between 50-80 years
• screened as healthy in a structured telephone interview

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Medicine Greifswald: lead
• Technische Universität Berlin: collaborator

Study Sites (1)

University medicine Greifswald

Greifswald, 17475, Germany

Location

Related Publications (1)

• 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.

  PMID: 35981956 DERIVED

Study Officials

• Agnes Floeel, Prof.

  University Medicine Greifswald

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 7 experimental stimulation conditions (including sham stimulation) are tested in a randomized, counterbalanced, within-subject design

Study Record Dates

• First Submitted: December 14, 2018
• First Posted: January 19, 2021
• Study Start: December 1, 2018
• Primary Completion: January 5, 2021
• Study Completion: January 31, 2021
• Last Updated: June 11, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)