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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Charite University, Berlin, Germany
Sponsor:
Information provided by (Responsible Party):
Agnes Flöel, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT01782365
First received: January 31, 2013
Last updated: June 2, 2014
Last verified: June 2014
  Purpose

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 Intervention
Mild Cognitive Impairment, So Stated
Device: SHAM stimulation
Device: 0,75 Hz stimulation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, 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)

Resource links provided by NLM:


Further study details as provided by Charite University, Berlin, Germany:

Primary Outcome Measures:
  • Retention of declarative memories after 0.75 Hz stimulation during SWS, vs after sham stimulation during SWS [ Time Frame: 4 Weeks ] [ Designated as safety issue: No ]
    Retention between stimulation conditions (0.75 Hz during SWS, vs sham stimulation during SWS) in the declarative memory task.


Secondary Outcome Measures:
  • Amount of Slow wave Sleep, spindels, eeg-correlates, further memory systems [ Time Frame: 4 Weeks ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 22
Study Start Date: April 2013
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 0,75 Hz stimulation
transcranial slow oscilliating stimulation (tSOS)during periods of SWS
Device: 0,75 Hz stimulation
Other Name: oscillating direct current brain stimulation
Sham Comparator: SHAM stimulation
SHAM stimulation during periods of SWS
Device: SHAM stimulation
no stimulation

  Eligibility

Ages Eligible for Study:   50 Years to 80 Years
Genders Eligible for Study:   Both
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: 50-80 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01782365

Contacts
Contact: Julia Schneider, M. sc. 030/450 560 136 schneider.julia@charite.de
Contact: Nadine Külzow, Dr 030/ 450 560 140 nadine.külzow@charite.de

Locations
Germany
Charite CCM Neurologie Berlin Recruiting
Berlin, Germany, 10117
Contact: Julia Schneider, M.sc.    + 49/ 30/ 450 560 136    schneider.julia@charite.de   
Contact: Agnes Flöel, Prof. Dr.    +49/ 30/ 450 560 284    agnes.floeel@charite.de   
Sub-Investigator: Nadine Külzow, Dr.         
Sub-Investigator: Julia Schneider, M.sc.         
Principal Investigator: Agnes Flöel, Prof. Dr.         
Sponsors and Collaborators
Charite University, Berlin, Germany
Investigators
Study Chair: Agnes Flöel, Professor Charite Universitätsmedizin Berlin - Neurologie
  More Information

Publications:
Responsible Party: Agnes Flöel, Prof. Agnes Flöel, MD, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT01782365     History of Changes
Other Study ID Numbers: Nap-tSOS-MCI
Study First Received: January 31, 2013
Last Updated: June 2, 2014
Health Authority: Germany: Ethics Commission

Keywords provided by Charite University, Berlin, Germany:
mild cognitive impairment
dementia
MCI
brain stimulation
tSOS
tDCS
sleep
nap
daytime sleep
memory
memory consolidation

Additional relevant MeSH terms:
Cognition Disorders
Mild Cognitive Impairment
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on August 26, 2014