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Effects of Brain Stimulation During a Daytime Nap on Memory Consolidation in Patients With Mild Cognitive Impairment

Sponsor
Charite University, Berlin, Germany (Other)
Overall Status
Completed
CT.gov ID
NCT01782365
Collaborator
(none)
16
Enrollment
1
Location
2
Arms
36.7
Actual Duration (Months)
0.4
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: SHAM stimulation
  • Device: 0,75 Hz stimulation
 N/A

Study Design

Study Type:
Interventional
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 :
Aug 8, 2013
Actual Primary Completion Date :
Apr 26, 2016
Actual Study Completion Date :
Aug 30, 2016

Arms and Interventions

Arm Intervention/Treatment
Experimental: 0,75 Hz stimulation

transcranial slow oscilliating stimulation (tSOS)during periods of SWS

Device: 0,75 Hz stimulation
Other Names:
  • oscillating direct current brain stimulation

    		•
    Sham Comparator: SHAM stimulation

    SHAM stimulation during periods of SWS

    Device: SHAM stimulation
    no stimulation

    Outcome Measures

    Primary Outcome Measures

    1. Retention of declarative memories after 0.75 Hz stimulation during SWS, vs after sham stimulation during SWS [4 Weeks]

      Retention between stimulation conditions (0.75 Hz during SWS, vs sham stimulation during SWS) in the declarative memory task.

    Secondary Outcome Measures

    1. Amount of Slow wave Sleep, spindels, eeg-correlates, further memory systems [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    50 Years to 90 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Charite CCM Neurologie Berlin Berlin Germany 10117

    Sponsors and Collaborators

    • Charite University, Berlin, Germany

    Investigators

    • Study Chair: Agnes Flöel, Professor, Charite Universitätsmedizin Berlin - Neurologie

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    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:
    Feb 1, 2013
    Last Update Posted:
    May 14, 2021
    Last Verified:
    May 1, 2021
    Keywords provided by Agnes Flöel, Prof. Agnes Flöel, MD, Charite University, Berlin, Germany
    mild cognitive impairment
    dementia
    MCI
    brain stimulation
    tSOS
    tDCS
    sleep
    nap
    daytime sleep
    memory
    memory consolidation
    Additional relevant MeSH terms:
    Cognitive Dysfunction

    Study Results

    No Results Posted as of May 14, 2021