- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01791790
Effects of Brain Stimulation During Nocturnal Sleep on Memory Consolidation in Elderly Healthy Subjects
May 20, 2021 updated by: Agnes Flöel, Charite University, Berlin, Germany
Impact of Transcranial Slow Oscillating Stimulation on Memory Consolidation During Nocturnal Slow Wave Sleep in Elderly 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.
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
32
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
-
-
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Berlin, Germany, 10117
- Charite CCM Neurologie Berlin
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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
50 years to 90 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- elederly, healthy Subjects
- unobtrusive, neuropsychological screening
- age: 50-90 years
- right handed
Exclusion Criteria:
- untreated severe internal or psychiatric diseases
- epilepsy
- other severe neurological diseases eg., previous major stroke, brain tumour, dementia
- 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
|
Other Names:
|
|
SHAM_COMPARATOR: SHAM stimulation
SHAM stimulation during periods of Slow Wave Sleep
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no stimulation
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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 between stimulation conditions (0.75 Hz during SWS, vs sham stimulation during SWS) in the declarative memory task.
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4 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Amount of Slow wave Sleep, spindels, eeg-correlates, further memory systems
Time Frame: 4 weeks
|
|
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.
- 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.
- 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. Erratum In: J Neurosci. 2005 Jan 12;25(2):1 p following 531.
- 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.
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)
December 1, 2016
Study Completion (ACTUAL)
December 1, 2016
Study Registration Dates
First Submitted
February 13, 2013
First Submitted That Met QC Criteria
February 13, 2013
First Posted (ESTIMATE)
February 15, 2013
Study Record Updates
Last Update Posted (ACTUAL)
May 24, 2021
Last Update Submitted That Met QC Criteria
May 20, 2021
Last Verified
May 1, 2021
More Information
Terms related to this study
Other Study ID Numbers
- Nighttime sleep-tSOS-Old
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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