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

NCT01782391 | Withdrawn DMC

• 1 other identifier: Nighttime sleep-tSOS-MCI
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Mild Cognitive Impairment, So Stated

Keywords

mild cognitive impairment; dementia; MCI; brain stimulation; tSOS; tDCS; sleep; memory; memory consolidation

Outcome Measures

Primary Outcomes (1)

• Retention of declarative memories after 0.75 Hz stimulation during SWS, vs after sham stimulation during SWS

  Retention between stimulation conditions (0.75 Hz during SWS, vs sham stimulation during SWS) in the declarative memory task.

  4 weeks

Secondary Outcomes (1)

• Amount of Slow wave Sleep, spindels, eeg-correlates, further memory systems

  4 weeks

Study Arms (2)

0,75 Hz stimulation

EXPERIMENTAL

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

Device: Stimulation

SHAM stimulation

SHAM COMPARATOR

SHAM stimulation during periods of Slow Wave Sleep

Device: SHAM

Interventions

Stimulation DEVICE

Also known as: oscillating direct current brain stimulation

0,75 Hz stimulation

SHAM DEVICE

no stimulation

SHAM stimulation

Eligibility Criteria

• Age: 50 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• amnestic and amnestic plus MCI-patients:
• Concern reflecting a change in cognition reported by patient or informant or clinician (i.e., historical or observed evidence of decline over time)
• Objective evidence of memory impairment; additional cognitive domains may be affected as well;
• Preservation of independence in functional abilities
• no dementia
• age: 50-90 years

You may not qualify if:

• untreated severe internal or psychiatric diseases
• epilepsy
• other severe neurological diseases eg., previous major stroke, brain tumour
• dementia
• contraindications to MRI

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead

Study Sites (1)

Charite CCM Neurologie Berlin

Berlin, 10117, Germany

Location

Related Publications (5)

• 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.

  PMID: 18977813 BACKGROUND

• 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.

  PMID: 17086200 BACKGROUND

• 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.

  PMID: 20046194 BACKGROUND

• 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.

  PMID: 18525028 BACKGROUND

• 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.

  PMID: 21531243 BACKGROUND

MeSH Terms

Conditions

Cognitive Dysfunction; Dementia

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Agnes Flöel, Professor

  Charite Universitätsmedizin Berlin - Neurologie

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Agnes Flöel, MD

Study Record Dates

• First Submitted: June 5, 2012
• First Posted: February 1, 2013
• Study Start: April 1, 2013
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: May 24, 2021

Record last verified: 2021-05

Locations

DE (1)