Clinical trial NCT01782365: Effects of Brain Stimulation During a Daytime Nap on Memory Consolidation in Patients With Mild Cognitive Impairment
Official 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mild Cognitive Impairment, So Stated
Keywords: mild cognitive impairment
dementia
MCI
brain stimulation
tSOS
tDCS
sleep
nap
daytime sleep
memory
memory consolidation
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2013-02-01
Enrollment: 16
Sex: ALL
Minimum age (years): 50
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Retention of declarative memories after 0.75 Hz stimulation during SWS, vs after sham stimulation during SWS
timeFrame: 4 Weeks
Secondary outcomes:
measure: Amount of Slow wave Sleep, spindels, eeg-correlates, further memory systems
timeFrame: 4 Weeks
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charite CCM Neurologie Berlin
Study officials:
affiliation: Charite Universitätsmedizin Berlin - Neurologie
name: Agnes Flöel, Professor
role: STUDY_CHAIR
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citation: Ladenbauer J, Ladenbauer J, Kulzow N, de Boor R, Avramova E, Grittner U, Floel A. Promoting Sleep Oscillations and Their Functional Coupling by Transcranial Stimulation Enhances Memory Consolidation in Mild Cognitive Impairment. J Neurosci. 2017 Jul 26;37(30):7111-7124. doi: 10.1523/JNEUROSCI.0260-17.2017. Epub 2017 Jun 21.
citation: Rackoll T, Neumann K, Passmann S, Grittner U, Kulzow N, Ladenbauer J, Floel A. Applying time series analyses on continuous accelerometry data-A clinical example in older adults with and without cognitive impairment. PLoS One. 2021 May 13;16(5):e0251544. doi: 10.1371/journal.pone.0251544. eCollection 2021.
citation: Ladenbauer J, Ladenbauer J, Kulzow N, Floel A. Memory-relevant nap sleep physiology in healthy and pathological aging. Sleep. 2021 Jul 9;44(7):zsab002. doi: 10.1093/sleep/zsab002.