We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01782365
Recruitment Status : Active, not recruiting
First Posted : February 1, 2013
Last Update Posted : July 6, 2017
Sponsor:
Information provided by (Responsible Party):

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

Study Design

Study Type : Interventional  (Clinical Trial)
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)
Study Start Date : April 2013
Primary Completion Date : August 2016
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Memory
U.S. FDA Resources

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 Name: 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 [ 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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   50 Years to 90 Years   (Adult, Senior)
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

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): NCT01782365


Locations
Germany
Charite CCM Neurologie Berlin
Berlin, Germany, 10117
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
First Posted: February 1, 2013    Key Record Dates
Last Update Posted: July 6, 2017
Last Verified: July 2017

Keywords provided by Agnes Flöel, 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
Cognition Disorders
Neurocognitive Disorders
Mental Disorders