Effects of Brain Stimulation During a Daytime Nap on Memory Consolidation in Patients With Mild Cognitive Impairment

May 12, 2021 updated by: Agnes Flöel, Charite University, Berlin, Germany

Impact of Transcranial Slow Oscillating Stimulation on Memory Consolidation During Slow Wave Sleep of a Daytime Nap in Patients With Mild Cognitive Impairment(MCI)

The beneficial effect of nocturnal as well as daytime sleep on memory consolidation is well-documented in young, healthy subjects. Slow wave sleep (SWS), in particular, with its slow oscillating activity have shown to enhance declarative, hippocampus-dependent memory representations. This impact of sleep on memory performance can be additionally enhanced by exogeneous induction of transcranial slow oscillating stimulation (tSOS) within the frequency range of SWS in humans (0,7- 0,8 Hz) during sleep, as has been demonstrated in young, healthy subjects. If patients with amnestic mild cognitive impairment (MCI)- usually characterized by initial difficulties in hippocampus dependent memory functions - benefit from transcranial slow oscillatory stimulation (tSOS) during sleep as well has not been studied so far. The primary goal of the study is therefore to investigate the impact of oscillating current stimulation (tSOS) during a daytime nap on declarative memory consolidation in MCI patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

16

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

  • Germany
      • Berlin, Germany, 10117
        • Charite CCM Neurologie Berlin

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 90 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • amnestic and amnestic plus MCI-patients:

    1. Concern reflecting a change in cognition reported by patient or informant or clinician (i.e., historical or observed evidence of decline over time)
    2. Objective evidence of memory impairment; additional cognitive domains may be affected as well;
    3. Preservation of independence in functional abilities
    4. no dementia
  • age: 50-90 years

Exclusion Criteria:

  • untreated severe internal or psychiatric diseases
  • epilepsy
  • other severe neurological diseases eg., previous major stroke, brain tumour
  • dementia
  • contraindications to MRI

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: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 0,75 Hz stimulation
transcranial slow oscilliating stimulation (tSOS)during periods of SWS
Device: 0,75 Hz stimulation
Other Names:
  • oscillating direct current brain stimulation
SHAM_COMPARATOR: SHAM stimulation
SHAM stimulation during periods of SWS
Device: SHAM stimulation
no stimulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Retention of declarative memories after 0.75 Hz stimulation during SWS, vs after sham stimulation during SWS
Time Frame: 4 Weeks
Retention between stimulation conditions (0.75 Hz during SWS, vs sham stimulation during SWS) in the declarative memory task.
4 Weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Amount of Slow wave Sleep, spindels, eeg-correlates, further memory systems
Time Frame: 4 Weeks
  1. Amount of slow wave sleep assessed by standard polysomnographic criteria in 0,75 Hz vs SHAM stimulation during SWS.
  2. Spindel activity during sleep indicated via several spindel parameters like number, duration, frequency of spindles; compared between 0,75 Hz and SHAM stimulation during SWS.
  3. Neuronal correlates (EEG-power in slow oscillation frequency bands induced by 0,75 Hz vs SHAM stimulation during SWS; EEG-correlates of encoding and retrieval of a declarative memory task).
  4. Performance in further memory systems (procedural), compared between 0,75 Hz and SHAM stimulation during SWS.
4 Weeks

Collaborators and Investigators

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

Sponsor

Charite University, Berlin, Germany

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.

General Publications

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)

August 8, 2013

Primary Completion (ACTUAL)

April 26, 2016

Study Completion (ACTUAL)

August 30, 2016

Study Registration Dates

First Submitted

January 31, 2013

First Submitted That Met QC Criteria

January 31, 2013

First Posted (ESTIMATE)

February 1, 2013

Study Record Updates

Last Update Posted (ACTUAL)

May 14, 2021

Last Update Submitted That Met QC Criteria

May 12, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Nap-tSOS-MCI

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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