search
Back to results

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

Primary Purpose

Mild Cognitive Impairment, So Stated

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
SHAM stimulation
0,75 Hz stimulation
Sponsored by
Charite University, Berlin, Germany
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mild Cognitive Impairment, So Stated focused on measuring mild cognitive impairment, dementia, MCI, brain stimulation, tSOS, tDCS, sleep, nap, daytime sleep, memory, memory consolidation

Eligibility Criteria

50 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Charite CCM Neurologie Berlin

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

0,75 Hz stimulation

SHAM stimulation

Arm Description

transcranial slow oscilliating stimulation (tSOS)during periods of SWS

SHAM stimulation during periods of SWS

Outcomes

Primary Outcome Measures

Retention of declarative memories after 0.75 Hz stimulation during SWS, vs after sham stimulation during SWS
Retention between stimulation conditions (0.75 Hz during SWS, vs sham stimulation during SWS) in the declarative memory task.

Secondary Outcome Measures

Amount of Slow wave Sleep, spindels, eeg-correlates, further memory systems
Amount of slow wave sleep assessed by standard polysomnographic criteria in 0,75 Hz vs SHAM stimulation during SWS. 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. 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). Performance in further memory systems (procedural), compared between 0,75 Hz and SHAM stimulation during SWS.

Full Information

First Posted
January 31, 2013
Last Updated
May 12, 2021
Sponsor
Charite University, Berlin, Germany
search

1. Study Identification

Unique Protocol Identification Number
NCT01782365
Brief Title
Effects of Brain Stimulation During a Daytime Nap on Memory Consolidation in Patients With Mild Cognitive Impairment
Official Title
Impact of Transcranial Slow Oscillating Stimulation on Memory Consolidation During Slow Wave Sleep of a Daytime Nap in Patients With Mild Cognitive Impairment(MCI)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
August 8, 2013 (Actual)
Primary Completion Date
April 26, 2016 (Actual)
Study Completion Date
August 30, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Charite University, Berlin, Germany

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild Cognitive Impairment, So Stated
Keywords
mild cognitive impairment, dementia, MCI, brain stimulation, tSOS, tDCS, sleep, nap, daytime sleep, memory, memory consolidation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
0,75 Hz stimulation
Arm Type
Experimental
Arm Description
transcranial slow oscilliating stimulation (tSOS)during periods of SWS
Arm Title
SHAM stimulation
Arm Type
Sham Comparator
Arm Description
SHAM stimulation during periods of SWS
Intervention Type
Device
Intervention Name(s)
SHAM stimulation
Intervention Description
no stimulation
Intervention Type
Device
Intervention Name(s)
0,75 Hz stimulation
Other Intervention Name(s)
oscillating direct current brain stimulation
Primary Outcome Measure Information:
Title
Retention of declarative memories after 0.75 Hz stimulation during SWS, vs after sham stimulation during SWS
Description
Retention between stimulation conditions (0.75 Hz during SWS, vs sham stimulation during SWS) in the declarative memory task.
Time Frame
4 Weeks
Secondary Outcome Measure Information:
Title
Amount of Slow wave Sleep, spindels, eeg-correlates, further memory systems
Description
Amount of slow wave sleep assessed by standard polysomnographic criteria in 0,75 Hz vs SHAM stimulation during SWS. 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. 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). Performance in further memory systems (procedural), compared between 0,75 Hz and SHAM stimulation during SWS.
Time Frame
4 Weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: amnestic and amnestic plus MCI-patients: Concern reflecting a change in cognition reported by patient or informant or clinician (i.e., historical or observed evidence of decline over time) Objective evidence of memory impairment; additional cognitive domains may be affected as well; Preservation of independence in functional abilities 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Agnes Flöel, Professor
Organizational Affiliation
Charite Universitätsmedizin Berlin - Neurologie
Official's Role
Study Chair
Facility Information:
Facility Name
Charite CCM Neurologie Berlin
City
Berlin
ZIP/Postal Code
10117
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
17086200
Citation
Marshall L, Helgadottir H, Molle M, Born J. Boosting slow oscillations during sleep potentiates memory. Nature. 2006 Nov 30;444(7119):610-3. doi: 10.1038/nature05278. Epub 2006 Nov 5.
Results Reference
background
PubMed Identifier
20046194
Citation
Diekelmann S, Born J. The memory function of sleep. Nat Rev Neurosci. 2010 Feb;11(2):114-26. doi: 10.1038/nrn2762. Epub 2010 Jan 4.
Results Reference
background
PubMed Identifier
18525028
Citation
Ferrucci R, Mameli F, Guidi I, Mrakic-Sposta S, Vergari M, Marceglia S, Cogiamanian F, Barbieri S, Scarpini E, Priori A. Transcranial direct current stimulation improves recognition memory in Alzheimer disease. Neurology. 2008 Aug 12;71(7):493-8. doi: 10.1212/01.wnl.0000317060.43722.a3. Epub 2008 Jun 4.
Results Reference
background
PubMed Identifier
21531243
Citation
Naismith SL, Lewis SJ, Rogers NL. Sleep-wake changes and cognition in neurodegenerative disease. Prog Brain Res. 2011;190:21-52. doi: 10.1016/B978-0-444-53817-8.00002-5.
Results Reference
background
PubMed Identifier
18554731
Citation
Mednick SC, Cai DJ, Kanady J, Drummond SP. Comparing the benefits of caffeine, naps and placebo on verbal, motor and perceptual memory. Behav Brain Res. 2008 Nov 3;193(1):79-86. doi: 10.1016/j.bbr.2008.04.028. Epub 2008 May 8.
Results Reference
background
PubMed Identifier
21377092
Citation
Mander BA, Santhanam S, Saletin JM, Walker MP. Wake deterioration and sleep restoration of human learning. Curr Biol. 2011 Mar 8;21(5):R183-4. doi: 10.1016/j.cub.2011.01.019. No abstract available.
Results Reference
background
PubMed Identifier
12819785
Citation
Mednick S, Nakayama K, Stickgold R. Sleep-dependent learning: a nap is as good as a night. Nat Neurosci. 2003 Jul;6(7):697-8. doi: 10.1038/nn1078.
Results Reference
background
PubMed Identifier
28637840
Citation
Ladenbauer J, Ladenbauer J, Kulzow N, de Boor R, Avramova E, Grittner U, Floel A. Promoting Sleep Oscillations and Their Functional Coupling by Transcranial Stimulation Enhances Memory Consolidation in Mild Cognitive Impairment. J Neurosci. 2017 Jul 26;37(30):7111-7124. doi: 10.1523/JNEUROSCI.0260-17.2017. Epub 2017 Jun 21.
Results Reference
result
PubMed Identifier
33984029
Citation
Rackoll T, Neumann K, Passmann S, Grittner U, Kulzow N, Ladenbauer J, Floel A. Applying time series analyses on continuous accelerometry data-A clinical example in older adults with and without cognitive impairment. PLoS One. 2021 May 13;16(5):e0251544. doi: 10.1371/journal.pone.0251544. eCollection 2021.
Results Reference
derived
PubMed Identifier
33406266
Citation
Ladenbauer J, Ladenbauer J, Kulzow N, Floel A. Memory-relevant nap sleep physiology in healthy and pathological aging. Sleep. 2021 Jul 9;44(7):zsab002. doi: 10.1093/sleep/zsab002.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs