We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Effects of Brain Stimulation During a Daytime Nap on Memory Consolidation in Older Adults

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01840839
Recruitment Status : Completed
First Posted : April 26, 2013
Last Update Posted : January 30, 2018
Sponsor:
Information provided by (Responsible Party):
Agnes Flöel, Charite University, Berlin, Germany

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Older Adults (50-90 Years) Device: brain stimulation Device: Sham Stimulation Not Applicable

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Impact of Transcranial Slow Oscillating Stimulation on Memory Consolidation During Slow Wave Sleep in Older Adults
Study Start Date : October 2013
Actual Primary Completion Date : May 2015
Actual Study Completion Date : August 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Memory

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: 0,75 Hz stimulation
transcranial slow oscilliating stimulation (tSOS)during periods of SWS
 Device: brain stimulation
Other Name: oscillating direct current brain stimulation
Sham Comparator: no stimulation
Sham stimulation during periods of SWS
 Device: Sham Stimulation
Other Name: no stimulation


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Retention of declarative memories after 0.75 Hz stimulation during SWS, vs after sham stimulation during SWS [ Time Frame: 4 weeks ]
    Retention between stimulation conditions (0.75 Hz during SWS, vs sham stimulation during SWS) in the declarative memory task.


Secondary Outcome Measures :
  1. 1. Amount of Slow wave Sleep [ Time Frame: 4 weeks ]
    1. Amount of slow wave sleep assessed by standard polysomnographic criteria in 0,75 Hz vs SHAM stimulation during SWS.

  2. 2. sleep spindels [ Time Frame: 4 weeks ]
    2.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.

  3. 3. EEG-correlates [ Time Frame: 4 weeks ]
    3. 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).

  4. 4. further memory systems [ Time Frame: 4 weeks ]
    4. Performance in further memory systems (procedural), compared between 0,75 Hz and SHAM stimulation during SWS.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   50 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • untreated severe internal or psychiatric diseases
  • epilepsy
  • other severe neurological diseases eg., previous major stroke, brain tumour
  • dementia
  • contraindications to MRI
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01840839


Locations
Layout table for location information
Germany
Charite CCM Neurologie Berlin
Berlin, Germany, 10117
Sponsors and Collaborators
Charite University, Berlin, Germany
Investigators
Layout table for investigator information
Study Chair: Agnes Flöel, Professor Charite Universitätsmedizin Berlin - Neurologie
Principal Investigator: Agnes Flöel, Professor Charite Universitätsmedizin Berlin - Neurologie
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications of Results:

Other Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: Agnes Flöel, Prof. Agnes Flöel, MD, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT01840839    
Other Study ID Numbers: Nap-tSOS-aged
First Posted: April 26, 2013    Key Record Dates
Last Update Posted: January 30, 2018
Last Verified: January 2018
Keywords provided by Agnes Flöel, Charite University, Berlin, Germany:
aging
cognitive decline
brain stimulation
tSOS
tDCS
 sleep
nap
daytime sleep
memory
memory consolidation