Mild Cognitive Impairment, So StatedNCT01782365

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

A study testing 0,75 Hz stimulation in people with Mild Cognitive Impairment, So Stated, run by Charite University, Berlin, Germany at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 50 to 90 years
Conditions the study is for: Mild Cognitive Impairment, So Stated
What is being tested?: 0,75 Hz stimulation
Type of treatment: Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 16 participants
Where: 1 siteGermany
Study dates: 8 Aug 2013to 30 Aug 2016
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 50 to 90 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Germany1 site

Charite CCM Neurologie Berlin
Berlin, 10117

Other trials in Germany

About this study

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)

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
Being tested: SHAM stimulation, 0,75 Hz stimulation
Keywords: mild cognitive impairment, dementia, MCI, brain stimulation, tSOS, tDCS, sleep, nap, daytime sleep, memory, memory consolidation
Medical subject headings: Cognitive Dysfunction, Dementia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

SHAM stimulationDevice
no stimulation
0,75 Hz stimulationDevice
Also called oscillating direct current brain stimulation

Study groups in NCT01782365
Study group	Role	What they receive
0,75 Hz stimulation	Experimental	transcranial slow oscilliating stimulation (tSOS)during periods of SWS Receives: Device: 0,75 Hz stimulation
SHAM stimulation	Sham comparator	SHAM stimulation during periods of SWS Receives: Device: SHAM stimulation

What is being measured

The primary outcome is the main question the study is designed to answer.

Retention of declarative memories after 0.75 Hz stimulation during SWS, vs after sham stimulation during SWS
Retention between stimulation conditions (0.75 Hz during SWS, vs sham stimulation during SWS) in the declarative memory task.
Measured: 4 Weeks

Secondary outcomes (1)

Amount of Slow wave Sleep, spindels, eeg-correlates, further memory systems
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.
Measured: 4 Weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

8 Aug 201330 Aug 2016

First posted1 Feb 2013 (estimated)
Study start8 Aug 2013
Primary completion26 Apr 2016
Study completion30 Aug 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (10)Papers the sponsor has linked to this study.
Other trials for Mild Cognitive Impairment, So StatedStudies of the same condition, open and under way.
More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 16 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01782365
Sponsor's protocol ID: Nap-tSOS-MCI
Status last verified: May 2021
First submitted: 31 Jan 2013
Last updated: 14 May 2021
Results posted: No
Data monitoring committee: Yes

Publications

Marshall L, Helgadottir H, Molle M, Born J. Boosting slow oscillations during sleep potentiates memory. Nature. 2006 Nov 30;444(7119):610-3. doi: 10.1038/nature05278. Epub 2006 Nov 5.
PubMed 17086200
Diekelmann S, Born J. The memory function of sleep. Nat Rev Neurosci. 2010 Feb;11(2):114-26. doi: 10.1038/nrn2762. Epub 2010 Jan 4.
PubMed 20046194
Ferrucci R, Mameli F, Guidi I, Mrakic-Sposta S, Vergari M, Marceglia S, Cogiamanian F, Barbieri S, Scarpini E, Priori A. Transcranial direct current stimulation improves recognition memory in Alzheimer disease. Neurology. 2008 Aug 12;71(7):493-8. doi: 10.1212/01.wnl.0000317060.43722.a3. Epub 2008 Jun 4.
PubMed 18525028
Naismith SL, Lewis SJ, Rogers NL. Sleep-wake changes and cognition in neurodegenerative disease. Prog Brain Res. 2011;190:21-52. doi: 10.1016/B978-0-444-53817-8.00002-5.
PubMed 21531243
Mednick SC, Cai DJ, Kanady J, Drummond SP. Comparing the benefits of caffeine, naps and placebo on verbal, motor and perceptual memory. Behav Brain Res. 2008 Nov 3;193(1):79-86. doi: 10.1016/j.bbr.2008.04.028. Epub 2008 May 8.
PubMed 18554731
Mander BA, Santhanam S, Saletin JM, Walker MP. Wake deterioration and sleep restoration of human learning. Curr Biol. 2011 Mar 8;21(5):R183-4. doi: 10.1016/j.cub.2011.01.019. No abstract available.
PubMed 21377092
Mednick S, Nakayama K, Stickgold R. Sleep-dependent learning: a nap is as good as a night. Nat Neurosci. 2003 Jul;6(7):697-8. doi: 10.1038/nn1078.
PubMed 12819785
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.
PubMed 28637840
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.
PubMed 33984029
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.
PubMed 33406266

Study at a glance

From the registry record, last updated by the sponsor on 14 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

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)
ClinicalTrials.gov ID: NCT01782365
Acronym / sponsor ID: Nap-tSOS-MCI
Conditions: Mild Cognitive Impairment, So Stated
Keywords: mild cognitive impairment, dementia, MCI, brain stimulation, tSOS, tDCS, sleep, nap
Study type: Interventional
Recruitment status: Completed
Enrolment: 16 participants (actual)
Lead sponsor: Charite University, Berlin, GermanyUniversity, hospital or other
Study start: 8 Aug 2013 (actual)
Primary completion: 26 Apr 2016 (actual)
Study completion: 30 Aug 2016 (actual)
First posted: 1 Feb 2013 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 2

Arm	Type	Receives
0,75 Hz stimulation	Experimental	Device: 0,75 Hz stimulationtranscranial slow oscilliating stimulation (tSOS)during periods of SWS
SHAM stimulation	Sham comparator	Device: SHAM stimulationSHAM stimulation during periods of SWS

Who may qualify

Ages: 50 to 90 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

amnestic and amnestic plus MCI-patients:
age: 50-90 years

Key exclusion criteria (5 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
SHAM stimulationno stimulation	Device	SHAM stimulation
0,75 Hz stimulationAlso: oscillating direct current brain stimulation	Device	0,75 Hz stimulation

Primary outcome

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.

1 secondary outcome

Amount of Slow wave Sleep, spindels, eeg-correlates, further memory systems
Time frame: 4 Weeks

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2021.
Background: PubMed 17086200Marshall L, Helgadottir H, Molle M, Born J. Boosting slow oscillations during sleep potentiates memory. Nature. 2006 Nov 30;444(7119):610-3. doi: 10.1038/nature05278. Epub 2006 Nov 5.
Background: PubMed 20046194Diekelmann S, Born J. The memory function of sleep. Nat Rev Neurosci. 2010 Feb;11(2):114-26. doi: 10.1038/nrn2762. Epub 2010 Jan 4.
Background: PubMed 18525028Ferrucci R, Mameli F, Guidi I, Mrakic-Sposta S, Vergari M, Marceglia S, Cogiamanian F, Barbieri S, Scarpini E, Priori A. Transcranial direct current stimulation improves recognition memory in Alzheimer disease. Neurology. 2008 Aug 12;71(7):493-8. doi: 10.1212/01.wnl.0000317060.43722.a3. Epub 2008 Jun 4.
Background: PubMed 21531243Naismith SL, Lewis SJ, Rogers NL. Sleep-wake changes and cognition in neurodegenerative disease. Prog Brain Res. 2011;190:21-52. doi: 10.1016/B978-0-444-53817-8.00002-5.
Background: PubMed 18554731Mednick SC, Cai DJ, Kanady J, Drummond SP. Comparing the benefits of caffeine, naps and placebo on verbal, motor and perceptual memory. Behav Brain Res. 2008 Nov 3;193(1):79-86. doi: 10.1016/j.bbr.2008.04.028. Epub 2008 May 8.
Background: PubMed 21377092Mander BA, Santhanam S, Saletin JM, Walker MP. Wake deterioration and sleep restoration of human learning. Curr Biol. 2011 Mar 8;21(5):R183-4. doi: 10.1016/j.cub.2011.01.019. No abstract available.
Background: PubMed 12819785Mednick S, Nakayama K, Stickgold R. Sleep-dependent learning: a nap is as good as a night. Nat Neurosci. 2003 Jul;6(7):697-8. doi: 10.1038/nn1078.
Results publication: PubMed 28637840Ladenbauer 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.
Derived from this study: PubMed 33984029Rackoll 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.
Derived from this study: PubMed 33406266Ladenbauer 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.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Agnes Flöel, Professor study chair

Charite Universitätsmedizin Berlin - Neurologie

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing 0,75 Hz stimulation in people with Mild Cognitive Impairment, So Stated, run by Charite University, Berlin, Germany at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 May 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Retention of declarative memories after 0.75 Hz stimulation during SWS, vs after sham stimulation during SWS (time frame: 4 Weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01782365, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2021.