Effects of Brain Stimulation During a Daytime Nap on Memory Consolidation in Patients With Mild Cognitive Impairment

Not Applicable

Completed

• Conditions: Mild Cognitive Impairment, So Stated
• Interventions: Device: 0,75 Hz stimulation; Device: SHAM stimulation

• Registration Number: NCT01782365
• Lead Sponsor: Charite University, Berlin, Germany

Brief Summary

The beneficial effect of nocturnal as well as daytime sleep on memory consolidation is well-documented in young, healthy subjects. Slow wave sleep (SWS), in particular, with its slow oscillating activity have shown to enhance declarative, hippocampus-dependent memory representations. This impact of sleep on memory performance can be additionally enhanced by exogeneous induction of transcranial slow oscillating stimulation (tSOS) within the frequency range of SWS in humans (0,7- 0,8 Hz) during sleep, as has been demonstrated in young, healthy subjects. If patients with amnestic mild cognitive impairment (MCI)- usually characterized by initial difficulties in hippocampus dependent memory functions - benefit from transcranial slow oscillatory stimulation (tSOS) during sleep as well has not been studied so far. The primary goal of the study is therefore to investigate the impact of oscillating current stimulation (tSOS) during a daytime nap on declarative memory consolidation in MCI patients.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-01-31
• Study First Submitted QC: 2013-01-31
• Study First Posted: 2013-02-01
• Study Start: 2013-08-08
• Primary Completion: 2016-04-26
• Study Completion: 2016-08-30
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-12
• Last Update Posted: 2021-05-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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
0,75 Hz stimulation	0,75 Hz stimulation	transcranial slow oscilliating stimulation (tSOS)during periods of SWS
SHAM stimulation	SHAM stimulation	SHAM stimulation during periods of SWS

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