Effects of Brain Stimulation During a Daytime Nap on Memory Consolidation in Patients With Mild Cognitive Impairment
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ClinicalTrials.gov Identifier: NCT01782365 |
Recruitment Status :
Completed
First Posted : February 1, 2013
Last Update Posted : May 14, 2021
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Mild Cognitive Impairment, So Stated | Device: SHAM stimulation Device: 0,75 Hz stimulation | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 16 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 of a Daytime Nap in Patients With Mild Cognitive Impairment(MCI) |
Actual Study Start Date : | August 8, 2013 |
Actual Primary Completion Date : | April 26, 2016 |
Actual Study Completion Date : | August 30, 2016 |
Arm | Intervention/treatment |
---|---|
Experimental: 0,75 Hz stimulation
transcranial slow oscilliating stimulation (tSOS)during periods of SWS
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Device: 0,75 Hz stimulation
Other Name: oscillating direct current brain stimulation |
Sham Comparator: SHAM stimulation
SHAM stimulation during periods of SWS
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Device: SHAM stimulation
no stimulation |
- 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.
- Amount of Slow wave Sleep, spindels, eeg-correlates, further memory systems [ Time Frame: 4 Weeks ]
- Amount of slow wave sleep assessed by standard polysomnographic criteria in 0,75 Hz vs SHAM stimulation during SWS.
- 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.
- 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).
- Performance in further memory systems (procedural), compared between 0,75 Hz and SHAM stimulation during SWS.

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Ages Eligible for Study: | 50 Years to 90 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
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amnestic and amnestic plus MCI-patients:
- Concern reflecting a change in cognition reported by patient or informant or clinician (i.e., historical or observed evidence of decline over time)
- Objective evidence of memory impairment; additional cognitive domains may be affected as well;
- Preservation of independence in functional abilities
- no dementia
- age: 50-90 years
Exclusion Criteria:
- untreated severe internal or psychiatric diseases
- epilepsy
- other severe neurological diseases eg., previous major stroke, brain tumour
- dementia
- contraindications to MRI

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): NCT01782365
Germany | |
Charite CCM Neurologie Berlin | |
Berlin, Germany, 10117 |
Study Chair: | Agnes Flöel, Professor | Charite Universitätsmedizin Berlin - Neurologie |
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Agnes Flöel, Prof. Agnes Flöel, MD, Charite University, Berlin, Germany |
ClinicalTrials.gov Identifier: | NCT01782365 |
Other Study ID Numbers: |
Nap-tSOS-MCI |
First Posted: | February 1, 2013 Key Record Dates |
Last Update Posted: | May 14, 2021 |
Last Verified: | May 2021 |
mild cognitive impairment dementia MCI brain stimulation tSOS tDCS |
sleep nap daytime sleep memory memory consolidation |
Cognitive Dysfunction Cognition Disorders Neurocognitive Disorders Mental Disorders |