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

NCT ID: NCT01782365

Last Updated: 2021-05-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-08-08
• Study Completion Date: 2016-08-30

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.

Conditions

Mild Cognitive Impairment, So Stated

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

0,75 Hz stimulation

transcranial slow oscilliating stimulation (tSOS)during periods of SWS

Group Type: EXPERIMENTAL

0,75 Hz stimulation

Intervention Type: DEVICE

SHAM stimulation

SHAM stimulation during periods of SWS

Group Type: SHAM_COMPARATOR

SHAM stimulation

Intervention Type: DEVICE

no stimulation

Interventions

SHAM stimulation

no stimulation

Intervention Type: DEVICE

0,75 Hz stimulation

Intervention Type: DEVICE

Other Intervention Names

oscillating direct current brain stimulation

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

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Charite University, Berlin, Germany

OTHER

Sponsor Role: lead

Responsible Party

Agnes Flöel

Prof. Agnes Flöel, MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Agnes Flöel, Professor

Role: STUDY_CHAIR

Charite Universitätsmedizin Berlin - Neurologie

Locations

Charite CCM Neurologie Berlin

Berlin, , Germany

Countries

Germany

References

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Reference Type: RESULT

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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.

Reference Type: DERIVED

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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.

Reference Type: DERIVED

PMID: 33406266 (View on PubMed)

Other Identifiers

Nap-tSOS-MCI

Identifier Type: -

Identifier Source: org_study_id