NCT01832740

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. In this study we investigate if the 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 nocturnal SWS.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 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

Study Start

First participant enrolled

January 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 8, 2013

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 16, 2013

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
Last Updated

March 16, 2016

Status Verified

March 1, 2016

Enrollment Period

2 years

First QC Date

March 8, 2013

Last Update Submit

March 15, 2016

Conditions

Healthy Subjects

Keywords

young healthy subjectsbrain 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 (difference values between performance at retrieval after sleep minus performance at learning before sleep) 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

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

Device: brain stimulation

SHAM stimulation

EXPERIMENTAL

SHAM stimulation during periods of Slow Wave Sleep

Device: SHAM

Interventions

brain stimulationDEVICE

oscillating direct current brain stimulation

0,75 Hz stimulation
SHAMDEVICE

no stimulation

SHAM stimulation

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • healthy Subjects
  • unobtrusive, neuropsychological screening
  • age: 18-35 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
  • contraindications to MRI

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Charite CCM Neurologie Berlin

Berlin, State of Berlin, 10117, Germany

Location

Related Publications (2)

  • 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

MeSH Terms

Interventions

Deep Brain Stimulation

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsSurgical Procedures, Operative

Study Officials

  • 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

March 8, 2013

First Posted

April 16, 2013

Study Start

January 1, 2013

Primary Completion

January 1, 2015

Study Completion

January 1, 2015

Last Updated

March 16, 2016

Record last verified: 2016-03

Locations

DE(1)