NCT01782365

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 31, 2013

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 1, 2013

Completed
6 months until next milestone

Study Start

First participant enrolled

August 8, 2013

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 26, 2016

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2016

Completed
Last Updated

May 14, 2021

Status Verified

May 1, 2021

Enrollment Period

2.7 years

First QC Date

January 31, 2013

Last Update Submit

May 12, 2021

Conditions

Mild Cognitive Impairment, So Stated

Keywords

mild cognitive impairmentdementiaMCIbrain stimulationtSOStDCSsleepnapdaytime sleepmemorymemory consolidation

Outcome Measures

Primary Outcomes (1)

  • 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.

    4 Weeks

Secondary Outcomes (1)

  • Amount of Slow wave Sleep, spindels, eeg-correlates, further memory systems

    4 Weeks

Study Arms (2)

0,75 Hz stimulation

EXPERIMENTAL

transcranial slow oscilliating stimulation (tSOS)during periods of SWS

Device: 0,75 Hz stimulation

SHAM stimulation

SHAM COMPARATOR

SHAM stimulation during periods of SWS

Device: SHAM stimulation

Interventions

SHAM stimulationDEVICE

no stimulation

SHAM stimulation
0,75 Hz stimulationDEVICE
Also known as: oscillating direct current brain stimulation
0,75 Hz stimulation

Eligibility Criteria

Age50 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Charite CCM Neurologie Berlin

Berlin, 10117, Germany

Location

Related Publications (10)

  • 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.

    PMID: 17086200BACKGROUND

  • 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.

    PMID: 20046194BACKGROUND

  • 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.

    PMID: 18525028BACKGROUND

  • 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.

    PMID: 21531243BACKGROUND

  • 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.

    PMID: 18554731BACKGROUND

  • 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.

    PMID: 21377092BACKGROUND

  • 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.

    PMID: 12819785BACKGROUND

  • 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.

    PMID: 28637840RESULT

  • 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.

    PMID: 33984029DERIVED

  • 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.

    PMID: 33406266DERIVED

MeSH Terms

Conditions

Cognitive DysfunctionDementia

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Agnes Flöel, Professor

    Charite Universitätsmedizin Berlin - Neurologie

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Agnes Flöel, MD

Study Record Dates

First Submitted

January 31, 2013

First Posted

February 1, 2013

Study Start

August 8, 2013

Primary Completion

April 26, 2016

Study Completion

August 30, 2016

Last Updated

May 14, 2021

Record last verified: 2021-05

Locations

DE(1)