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OpenTrials
Completed

NCT Number: NCT01782365

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

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.

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Key information

Age range

50 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Charite CCM Neurologie Berlin

Berlin, 10117, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sham stimulation

Device

no stimulation

0,75 Hz stimulation

Device

Other names: oscillating direct current brain stimulation

Primary outcomes

  1. 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

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

    Time frame: 4 Weeks

    • 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.

Sponsors and collaborators

Lead sponsor

Charite University, Berlin, Germany

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Feb 1, 2013
Registry last updated
May 14, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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