- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01832740
Effects of Brain Stimulation During Nocturnal Sleep on Memory Consolidation in Younger, Healthy Subjects
March 15, 2016 updated by: Agnes Flöel, Charite University, Berlin, Germany
Impact of Transcranial Slow Oscillating Stimulation on Memory Consolidation During Nocturnal Slow Wave Sleep in Younger, Healthy Subjects
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
22
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Berlin, Germany, 10117
- Charite CCM Neurologie Berlin
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 35 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- healthy Subjects
- unobtrusive, neuropsychological screening
- age: 18-35 years
- right handed
Exclusion Criteria:
- untreated severe internal or psychiatric diseases
- epilepsy
- other severe neurological diseases eg., previous major stroke, brain tumour
- contraindications to MRI
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: TRIPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: 0,75 Hz stimulation
slow transcranial oscillating stimulation (~0,75Hz) during periods of Slow Wave Sleep
|
oscillating direct current brain stimulation
|
EXPERIMENTAL: SHAM stimulation
SHAM stimulation during periods of Slow Wave Sleep
|
no stimulation
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Retention of declarative memories after 0.75 Hz stimulation during SWS, vs after sham stimulation during SWS
Time Frame: 4 weeks
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
4 weeks
|
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 weeks
|
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.
|
4 weeks
|
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.
|
4 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2013
Primary Completion (ACTUAL)
January 1, 2015
Study Completion (ACTUAL)
January 1, 2015
Study Registration Dates
First Submitted
March 8, 2013
First Submitted That Met QC Criteria
April 12, 2013
First Posted (ESTIMATE)
April 16, 2013
Study Record Updates
Last Update Posted (ESTIMATE)
March 16, 2016
Last Update Submitted That Met QC Criteria
March 15, 2016
Last Verified
March 1, 2016
More Information
Terms related to this study
Other Study ID Numbers
- Nighttime sleep-tSOS-Young
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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