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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
Sponsor:
Information provided by (Responsible Party):
Agnes Flöel, Charite University, Berlin, Germany

Tracking Information
First Submitted Date  ICMJE January 31, 2013
First Posted Date  ICMJE February 1, 2013
Last Update Posted Date May 14, 2021
Actual Study Start Date  ICMJE August 8, 2013
Actual Primary Completion Date April 26, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 31, 2013)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 31, 2013)
Amount of Slow wave Sleep, spindels, eeg-correlates, further memory systems [ 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. 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. 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. Performance in further memory systems (procedural), compared between 0,75 Hz and SHAM stimulation during SWS.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of Brain Stimulation During a Daytime Nap on Memory Consolidation in Patients With Mild Cognitive Impairment
Official Title  ICMJE Impact of Transcranial Slow Oscillating Stimulation on Memory Consolidation During Slow Wave Sleep of a Daytime Nap in Patients With Mild Cognitive Impairment(MCI)
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 patients with amnestic mild cognitive impairment (MCI)- usually characterized by initial difficulties in hippocampus dependent memory functions - benefit from transcranial slow oscillatory stimulation (tSOS) during sleep as well 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 MCI patients.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Mild Cognitive Impairment, So Stated
Intervention  ICMJE
  • Device: SHAM stimulation
    no stimulation
  • Device: 0,75 Hz stimulation
    Other Name: oscillating direct current brain stimulation
Study Arms  ICMJE
  • Experimental: 0,75 Hz stimulation
    transcranial slow oscilliating stimulation (tSOS)during periods of SWS
    Intervention: Device: 0,75 Hz stimulation
  • Sham Comparator: SHAM stimulation
    SHAM stimulation during periods of SWS
    Intervention: Device: SHAM stimulation
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 20, 2016)
16
Original Estimated Enrollment  ICMJE
 (submitted: January 31, 2013)
22
Actual Study Completion Date  ICMJE August 30, 2016
Actual Primary Completion Date April 26, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • amnestic and amnestic plus MCI-patients:

    1. Concern reflecting a change in cognition reported by patient or informant or clinician (i.e., historical or observed evidence of decline over time)
    2. Objective evidence of memory impairment; additional cognitive domains may be affected as well;
    3. Preservation of independence in functional abilities
    4. 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01782365
Other Study ID Numbers  ICMJE Nap-tSOS-MCI
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Agnes Flöel, Charite University, Berlin, Germany
Study Sponsor  ICMJE Charite University, Berlin, Germany
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Agnes Flöel, Professor Charite Universitätsmedizin Berlin - Neurologie
PRS Account Charite University, Berlin, Germany
Verification Date May 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP