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Elderly SubjectsNCT01791790

Effects of Brain Stimulation During Nocturnal Sleep on Memory Consolidation in Elderly Healthy Subjects

A study testing Stimulation in people with Elderly Subjects, 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

The beneficial effect of nocturnal sleep on memory consolidation is well-documented in young, healthy subjects. Especially, periods rich in slow-wave sleep (SWS) have shown a memory enhancing effect on hippocampus-dependent declarative memory. Read more about this study

Who is it for?
Ages 50 to 90 yearsHealthy volunteers can take part
Conditions the study is for
Elderly Subjects
What is being tested?
Stimulation
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
32 participants
Where
1 siteGermany
Study dates
Jan 2013to Dec 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
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • elederly, healthy Subjects
  • unobtrusive, neuropsychological screening
  • age: 50-90 years
  • right handed

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 Nocturnal Slow Wave Sleep in Elderly Healthy Subjects

The beneficial effect of nocturnal sleep on memory consolidation is well-documented in young, healthy subjects. Especially, periods rich in slow-wave sleep (SWS) have shown a memory enhancing effect on hippocampus-dependent declarative memory. Slow oscillatory activity typically occuring during SWS has been implicated in the consolidation effect. Recent evidence in young healthy subjects suggest that the sleep-associated consolidation effect can be amplified by the application of a weak transcranial oscillatory electric current within the frequency range of SWS in humans (0,7-0,8 Hz) during SWS. If elderly, healthy subjects benefit from transcranial slow oscillatory stimulation (tSOS) during nocturnal sleep as well has not been studied so far. The primary aim of the present study is to investigate the influence of a weak slow oscillating brain stimulation (tSOS) on declarative memory consolidation applied during periods of nocturnal SWS in elderly healthy subjects.

Being tested
Stimulation, SHAM
Keywords
old Subjects, Controls, brain stimulation, tSOS, tDCS, sleep, memory, memory consolidation

What participants receive

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

  • StimulationDevice

    Also called oscillating direct current brain stimulation

  • SHAMDevice

    no stimulation

Study groups in NCT01791790
Study groupRoleWhat they receive
0,75 Hz stimulationExperimentalslow transcranial oscillating stimulation (~0,75Hz) during periods of Slow Wave Sleep
Receives: Device: Stimulation
SHAM stimulationSham comparatorSHAM stimulation during periods of Slow Wave Sleep
Receives: Device: SHAM

What is being measured

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

  1. 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)

  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.

  1. First posted15 Feb 2013 (estimated)
  2. Study startJan 2013
  3. Primary completionDec 2016
  4. Study completionDec 2016

Resources

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
32 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01791790
Sponsor's protocol ID
Nighttime sleep-tSOS-Old
Status last verified
May 2021
First submitted
13 Feb 2013
Last updated
24 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

  • 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

  • Marshall L, Molle M, Hallschmid M, Born J. Transcranial direct current stimulation during sleep improves declarative memory. J Neurosci. 2004 Nov 3;24(44):9985-92. doi: 10.1523/JNEUROSCI.2725-04.2004.

    PubMed 15525784

  • Passmann S, Kulzow N, Ladenbauer J, Antonenko D, Grittner U, Tamm S, Floel A. Boosting Slow Oscillatory Activity Using tDCS during Early Nocturnal Slow Wave Sleep Does Not Improve Memory Consolidation in Healthy Older Adults. Brain Stimul. 2016 Sep-Oct;9(5):730-739. doi: 10.1016/j.brs.2016.04.016. Epub 2016 Apr 28.

    PubMed 27247261

Questions about this trial

What is this clinical trial studying?

A study testing Stimulation in people with Elderly Subjects, 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 4 inclusion and 4 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 24 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 NCT01791790, which also lists 5 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 24 May 2021.

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