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

Mild Cognitive Impairment, So Stated Clinical Trial

Official title:

Impact of Transcranial Slow Oscillating Stimulation on Memory Consolidation During Nocturnal Slow Wave Sleep in Patients With Mild Cognitive Impairments(MCI)

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01782391
• Other study ID #: Nighttime sleep-tSOS-MCI
• Status: Withdrawn
• Phase: N/A
• Start date: April 2013
• Est. completion date: December 2017

Study information

• Verified date: May 2021
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Mild Cognitive Impairment, So Stated

Intervention

Device:
• Stimulation

• SHAM
no stimulation

Locations

Country	Name	City	State
Germany	Charite CCM Neurologie Berlin	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany

Country where clinical trial is conducted

Germany, 

References & 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Amount of Slow wave Sleep, spindels, eeg-correlates, further memory systems	Amount of slow wave sleep assessed by standard polysomnographic criteria in 0,75 Hz vs SHAM stimulation during SWS.; 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.; 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).; Performance in further memory systems (procedural), compared between 0,75 Hz and SHAM stimulation during SWS.	4 weeks