Effects of Brain Stimulation During Nocturnal Sleep on Memory Consolidation in Patients With Mild Cognitive Impairments
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|ClinicalTrials.gov Identifier: NCT01782391|
Recruitment Status : Withdrawn (Lack of appropriate participants)
First Posted : February 1, 2013
Last Update Posted : May 24, 2021
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|Condition or disease||Intervention/treatment||Phase|
|Mild Cognitive Impairment, So Stated||Device: Stimulation Device: SHAM||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Impact of Transcranial Slow Oscillating Stimulation on Memory Consolidation During Nocturnal Slow Wave Sleep in Patients With Mild Cognitive Impairments(MCI)|
|Study Start Date :||April 2013|
|Estimated Primary Completion Date :||December 2017|
|Estimated Study Completion Date :||December 2017|
Experimental: 0,75 Hz stimulation
slow transcranial oscillating stimulation (~0,75Hz) during periods of Slow Wave Sleep
Other Name: oscillating direct current brain stimulation
Sham Comparator: SHAM stimulation
SHAM stimulation during periods of Slow Wave Sleep
- 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|
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
- untreated severe internal or psychiatric diseases
- other severe neurological diseases eg., previous major stroke, brain tumour
- 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): NCT01782391
|Charite CCM Neurologie Berlin|
|Berlin, Germany, 10117|
|Study Chair:||Agnes Flöel, Professor||Charite Universitätsmedizin Berlin - Neurologie|
|Responsible Party:||Agnes Flöel, Prof. Agnes Flöel, MD, Charite University, Berlin, Germany|
|Other Study ID Numbers:||
|First Posted:||February 1, 2013 Key Record Dates|
|Last Update Posted:||May 24, 2021|
|Last Verified:||May 2021|
mild cognitive impairment