Effects of Brain Stimulation During Nocturnal Sleep on Memory Consolidation in Patients With Mild Cognitive Impairments - Full Text View

Purpose

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	Intervention
Mild Cognitive Impairment, So Stated	Device: Stimulation Device: SHAM

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 Nocturnal Slow Wave Sleep in Patients With Mild Cognitive Impairments(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:	February 2014
Estimated Primary Completion Date:	February 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

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: NCT01782391

Contacts

Contact: Sven Paßmann, M.sc.	030/450 560 395	sven.passmann@charite.de
Contact: Nadine Külzow, PhD	030/450 560 140	nadine.kuelzow@charite.de

Locations

Germany
Charite CCM Neurologie Berlin	Recruiting
Berlin, Germany, 10117
Contact: Sven Paßmann, M.sc. +49/30/450560395 sven.passmann@charite.de
Contact: Agnes Flöel, Prof. Dr. +49/30/450560284 agnes.floeel@charite.de
Sub-Investigator: Nadine Külzow, Dr.
Sub-Investigator: Sven Paßmann, 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:

Boggio PS, Khoury LP, Martins DC, Martins OE, de Macedo EC, Fregni F. Temporal cortex direct current stimulation enhances performance on a visual recognition memory task in Alzheimer disease. J Neurol Neurosurg Psychiatry. 2009 Apr;80(4):444-7. doi: 10.1136/jnnp.2007.141853. Epub 2008 Oct 31.

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.

Diekelmann S, Born J. The memory function of sleep. Nat Rev Neurosci. 2010 Feb;11(2):114-26. doi: 10.1038/nrn2762. Epub 2010 Jan 4. Review.

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.

Naismith SL, Lewis SJ, Rogers NL. Sleep-wake changes and cognition in neurodegenerative disease. Prog Brain Res. 2011;190:21-52. doi: 10.1016/B978-0-444-53817-8.00002-5. Review.

Responsible Party:	Agnes Floeel, Prof. Agnes Flöel, MD, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:	NCT01782391 History of Changes
Other Study ID Numbers:	Nighttime sleep-tSOS-MCI
Study First Received:	June 5, 2012
Last Updated:	May 27, 2013
Health Authority:	Germany: Ethics Commission

Keywords provided by Charite University, Berlin, Germany:

mild cognitive impairment
dementia
MCI
brain stimulation
tSOS

tDCS
sleep
memory
memory consolidation

Additional relevant MeSH terms:

Cognition Disorders
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on June 17, 2013