NCT01840839

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 older adults that commonly experiencing cognitive decline, including long-term retention of declarative memory - benefit from transcranial slow oscillatory stimulation (tSOS) during sleep in the same way 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 older adults.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 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

April 18, 2013

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 26, 2013

Completed
5 months until next milestone

Study Start

First participant enrolled

October 1, 2013

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
Last Updated

January 30, 2018

Status Verified

January 1, 2018

Enrollment Period

1.6 years

First QC Date

April 18, 2013

Last Update Submit

January 29, 2018

Conditions

Older Adults (50-90 Years)

Keywords

agingcognitive declinebrain 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 (4)

  • 1. Amount of Slow wave Sleep

    4 weeks

  • 2. sleep spindels

    4 weeks

  • 3. EEG-correlates

    4 weeks

  • 4. further memory systems

    4 weeks

Study Arms (2)

0,75 Hz stimulation

EXPERIMENTAL

transcranial slow oscilliating stimulation (tSOS)during periods of SWS

Device: brain stimulation

no stimulation

SHAM COMPARATOR

Sham stimulation during periods of SWS

Device: Sham Stimulation

Interventions

brain stimulationDEVICE
Also known as: oscillating direct current brain stimulation
0,75 Hz stimulation
Sham StimulationDEVICE
Also known as: no stimulation
no stimulation

Eligibility Criteria

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

You may qualify if:

  • age: 50-90 years
  • right handed
  • inobtrusive neuropsychological examination

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 (9)

  • 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, Kulzow N, Passmann S, Antonenko D, Grittner U, Tamm S, Floel A. Brain stimulation during an afternoon nap boosts slow oscillatory activity and memory consolidation in older adults. Neuroimage. 2016 Nov 15;142:311-323. doi: 10.1016/j.neuroimage.2016.06.057. Epub 2016 Jul 2.

    PMID: 27381076RESULT

  • 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 Dysfunction

Interventions

Deep Brain Stimulation

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsSurgical Procedures, Operative

Study Officials

  • Agnes Flöel, Professor

    Charite Universitätsmedizin Berlin - Neurologie

    STUDY CHAIR

  • Agnes Flöel, Professor

    Charite Universitätsmedizin Berlin - Neurologie

    PRINCIPAL INVESTIGATOR

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

April 18, 2013

First Posted

April 26, 2013

Study Start

October 1, 2013

Primary Completion

May 1, 2015

Study Completion

August 1, 2015

Last Updated

January 30, 2018

Record last verified: 2018-01

Locations

DE(1)