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

Not Applicable

Withdrawn

• Conditions: Mild Cognitive Impairment, So Stated
• Interventions: Device: SHAM; Device: Stimulation

• Registration Number: NCT01782391
• Lead Sponsor: Charite University, Berlin, Germany

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-06-05
• Study First Submitted QC: 2013-01-31
• Study First Posted: 2013-02-01
• Study Start: 2013-04
• Primary Completion: 2017-12
• Study Completion: 2017-12
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-20
• Last Update Posted: 2021-05-24

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
SHAM stimulation	SHAM	SHAM stimulation during periods of Slow Wave Sleep
0,75 Hz stimulation	Stimulation	slow transcranial oscillating stimulation (\~0,75Hz) during periods of Slow Wave Sleep

Primary Outcome Measures

Name	Time	Method
Retention of declarative memories after 0.75 Hz stimulation during SWS, vs after sham stimulation during SWS	4 weeks	Retention between stimulation conditions (0.75 Hz during SWS, vs sham stimulation during SWS) in the declarative memory task.

Secondary Outcome Measures

Name	Time	Method
Amount of Slow wave Sleep, spindels, eeg-correlates, further memory systems	4 weeks	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.

Trial Locations

Locations (1)

Charite CCM Neurologie Berlin; 🇩🇪 Berlin, Germany