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

NCT ID: NCT01782391

Last Updated: 2021-05-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2013-04-30

Study Completion Date

2017-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Mild Cognitive Impairment, So Stated

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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0,75 Hz stimulation

slow transcranial oscillating stimulation (\~0,75Hz) during periods of Slow Wave Sleep

Group Type EXPERIMENTAL

Stimulation

Intervention Type DEVICE

SHAM stimulation

SHAM stimulation during periods of Slow Wave Sleep

Group Type SHAM_COMPARATOR

SHAM

Intervention Type DEVICE

no stimulation

Interventions

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Stimulation

Intervention Type DEVICE

SHAM

no stimulation

Intervention Type DEVICE

Other Intervention Names

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oscillating direct current brain stimulation

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Charite University, Berlin, Germany

OTHER

Sponsor Role lead

Responsible Party

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Agnes Flöel

Prof. Agnes Flöel, MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Agnes Flöel, Professor

Role: STUDY_CHAIR

Charite Universitätsmedizin Berlin - Neurologie

Locations

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Charite CCM Neurologie Berlin

Berlin, , Germany

Site Status

Countries

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Germany

References

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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.

Reference Type BACKGROUND
PMID: 18977813 (View on PubMed)

Marshall L, Helgadottir H, Molle M, Born J. Boosting slow oscillations during sleep potentiates memory. Nature. 2006 Nov 30;444(7119):610-3. doi: 10.1038/nature05278. Epub 2006 Nov 5.

Reference Type BACKGROUND
PMID: 17086200 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20046194 (View on PubMed)

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. doi: 10.1212/01.wnl.0000317060.43722.a3. Epub 2008 Jun 4.

Reference Type BACKGROUND
PMID: 18525028 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21531243 (View on PubMed)

Other Identifiers

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Nighttime sleep-tSOS-MCI

Identifier Type: -

Identifier Source: org_study_id

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