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

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:

MedlinePlus related topics: Dementia Memory Mild Cognitive Impairment

U.S. FDA Resources

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 2014
Estimated Primary Completion Date:	March 2014 (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

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

Additional Information:

working group is related to healthy aging, cognitive impairments in aging and neurological rehabilitation after stroke This link exits the ClinicalTrials.gov site

This link exits the ClinicalTrials.gov site

Publications:

Marshall L, Helgadóttir H, Mölle M, Born J. Boosting slow oscillations during sleep potentiates memory. Nature. 2006 Nov 30;444(7119):610-3. Epub 2006 Nov 5.

Ferrucci R, Mameli F, Guidi I, Mrakic-Sposta S, Vergari M, Marceglia S, Cogiamanian F, Barbieri S, Scarpini E, Priori A. Transcranial direct current stimulation improves recognition memory in Alzheimer disease. Neurology. 2008 Aug 12;71(7):493-8. Epub 2008 Jun 4.

Mednick SC, Cai DJ, Kanady J, Drummond SP. Comparing the benefits of caffeine, naps and placebo on verbal, motor and perceptual memory. Behav Brain Res. 2008 Nov 3;193(1):79-86. doi: 10.1016/j.bbr.2008.04.028. Epub 2008 May 8.

Mander BA, Santhanam S, Saletin JM, Walker MP. Wake deterioration and sleep restoration of human learning. Curr Biol. 2011 Mar 8;21(5):R183-4. doi: 10.1016/j.cub.2011.01.019.

Mednick S, Nakayama K, Stickgold R. Sleep-dependent learning: a nap is as good as a night. Nat Neurosci. 2003 Jul;6(7):697-8.

Responsible Party:	Agnes Floeel, 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:	April 18, 2013
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
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on May 22, 2013