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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Recruitment Status : Withdrawn (Lack of appropriate participants)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
Sponsor:
Information provided by (Responsible Party):
Agnes Flöel, Charite University, Berlin, Germany

Study Description
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Brief Summary:
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 patients with amnestic mild cognitive impairments (MCI)- usually characterized by initial difficulties in hippocampus dependent memory functions - 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 MCI patients.

Condition or disease Intervention/treatment Phase
Mild Cognitive Impairment, So Stated Device: Stimulation Device: SHAM Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 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 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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Memory

Arms and Interventions
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Arm Intervention/treatment
Experimental: 0,75 Hz stimulation
slow transcranial oscillating stimulation (~0,75Hz) during periods of Slow Wave Sleep
 Device: Stimulation
Other Name: oscillating direct current brain stimulation
Sham Comparator: SHAM stimulation
SHAM stimulation during periods of Slow Wave Sleep
 Device: SHAM
no stimulation


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.


Eligibility Criteria
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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
Criteria

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
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Information from the National Library of Medicine

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


Locations
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Germany
Charite CCM Neurologie Berlin
Berlin, Germany, 10117
Sponsors and Collaborators
Charite University, Berlin, Germany
Investigators
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Study Chair: Agnes Flöel, Professor Charite Universitätsmedizin Berlin - Neurologie
More Information
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Publications:

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Responsible Party: Agnes Flöel, Prof. Agnes Flöel, MD, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT01782391    
Other Study ID Numbers: Nighttime sleep-tSOS-MCI
First Posted: February 1, 2013    Key Record Dates
Last Update Posted: May 24, 2021
Last Verified: May 2021
Keywords provided by Agnes Flöel, Charite University, Berlin, Germany:
mild cognitive impairment
dementia
MCI
brain stimulation
tSOS
 tDCS
sleep
memory
memory consolidation
Additional relevant MeSH terms:
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Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Mental Disorders