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Clinical Trials/NCT01782365
NCT01782365CompletedNot Applicable

Impact of Transcranial Slow Oscillating Stimulation on Memory Consolidation During Slow Wave Sleep of a Daytime Nap in Patients With Mild Cognitive Impairment(MCI)

Charite University, Berlin, Germany1 site in 1 country16 target enrollmentStarted: August 8, 2013Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
16
Locations
1
Primary Endpoint
Retention of declarative memories after 0.75 Hz stimulation during SWS, vs after sham stimulation during SWS

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Treatment
Masking
Triple (Participant, Care Provider, Investigator)

Eligibility Criteria

Ages
50 Years to 90 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •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

Exclusion Criteria

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

Arms & Interventions

0,75 Hz stimulation

Experimental

transcranial slow oscilliating stimulation (tSOS)during periods of SWS

Intervention: 0,75 Hz stimulation (Device)

SHAM stimulation

Sham Comparator

SHAM stimulation during periods of SWS

Intervention: SHAM stimulation (Device)

Outcomes

Primary Outcomes

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

Time Frame: 4 Weeks

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

Secondary Outcomes

  • Amount of Slow wave Sleep, spindels, eeg-correlates, further memory systems(4 Weeks)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Agnes Flöel

Prof. Agnes Flöel, MD

Charite University, Berlin, Germany

Study Sites (1)

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