NCT01791790

Brief Summary

The beneficial effect of nocturnal sleep on memory consolidation is well-documented in young, healthy subjects. Especially, periods rich in slow-wave sleep (SWS) have shown a memory enhancing effect on hippocampus-dependent declarative memory. Slow oscillatory activity typically occuring during SWS has been implicated in the consolidation effect. Recent evidence in young healthy subjects suggest that the sleep-associated consolidation effect can be amplified by the application of a weak transcranial oscillatory electric current within the frequency range of SWS in humans (0,7-0,8 Hz) during SWS. If elderly, healthy subjects benefit from transcranial slow oscillatory stimulation (tSOS) during nocturnal sleep as well has not been studied so far. The primary aim of the present study is to investigate the influence of a weak slow oscillating brain stimulation (tSOS) on declarative memory consolidation applied during periods of nocturnal SWS in elderly healthy subjects.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2013

Longer than P75 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

Study Start

First participant enrolled

January 1, 2013

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 13, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 15, 2013

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

May 24, 2021

Status Verified

May 1, 2021

Enrollment Period

3.9 years

First QC Date

February 13, 2013

Last Update Submit

May 20, 2021

Conditions

Elderly Subjects

Keywords

old SubjectsControlsbrain stimulationtSOStDCSsleepmemorymemory 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

slow transcranial oscillating stimulation (\~0,75Hz) during periods of Slow Wave Sleep

Device: Stimulation

SHAM stimulation

SHAM COMPARATOR

SHAM stimulation during periods of Slow Wave Sleep

Device: SHAM

Interventions

StimulationDEVICE
Also known as: oscillating direct current brain stimulation
0,75 Hz stimulation
SHAMDEVICE

no stimulation

SHAM stimulation

Eligibility Criteria

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

You may qualify if:

  • elederly, healthy Subjects
  • unobtrusive, neuropsychological screening
  • age: 50-90 years
  • right handed

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 (5)

  • 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

  • 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

  • Marshall L, Molle M, Hallschmid M, Born J. Transcranial direct current stimulation during sleep improves declarative memory. J Neurosci. 2004 Nov 3;24(44):9985-92. doi: 10.1523/JNEUROSCI.2725-04.2004.

    PMID: 15525784BACKGROUND

  • Passmann S, Kulzow N, Ladenbauer J, Antonenko D, Grittner U, Tamm S, Floel A. Boosting Slow Oscillatory Activity Using tDCS during Early Nocturnal Slow Wave Sleep Does Not Improve Memory Consolidation in Healthy Older Adults. Brain Stimul. 2016 Sep-Oct;9(5):730-739. doi: 10.1016/j.brs.2016.04.016. Epub 2016 Apr 28.

    PMID: 27247261RESULT

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

February 13, 2013

First Posted

February 15, 2013

Study Start

January 1, 2013

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

May 24, 2021

Record last verified: 2021-05

Locations

DE(1)