Mild Cognitive Impairment, So StatedNCT01782391
Effects of Brain Stimulation During Nocturnal Sleep on Memory Consolidation in Patients With Mild Cognitive Impairments
A study testing Stimulation in people with Mild Cognitive Impairment, So Stated, run by Charite University, Berlin, Germany at 1 site in Germany.
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 years
- Conditions the study is for
- Mild Cognitive Impairment, So Stated
- 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
- 0 participants
- Where
- 1 siteGermany
- Study dates
- Apr 2013to Dec 2017
- 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.
About this study
Official title: Impact of Transcranial Slow Oscillating Stimulation on Memory Consolidation During Nocturnal Slow Wave Sleep in Patients With Mild Cognitive Impairments(MCI)
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 patients with amnestic mild cognitive impairments (MCI)- usually characterized by initial difficulties in hippocampus dependent memory functions - 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 MCI patients.
- Conditions
- Mild Cognitive Impairment, So Stated
- Being tested
- Stimulation, SHAM
- Keywords
- mild cognitive impairment, dementia, MCI, brain stimulation, tSOS, tDCS, 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.
StimulationDevice
Also called oscillating direct current brain stimulation
SHAMDevice
no stimulation
| Study group | Role | What they receive |
|---|---|---|
| 0,75 Hz stimulation | Experimental | slow transcranial oscillating stimulation (~0,75Hz) during periods of Slow Wave Sleep Receives: Device: Stimulation |
| SHAM stimulation | Sham comparator | SHAM 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.
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
- 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.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2013 (estimated)
- Study startApr 2013
- Primary completionDec 2017 (estimated)
- Study completionDec 2017 (estimated)
Why it stopped: Lack of appropriate participants
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Agnes Flöel, Charite University, Berlin, Germany
- Investigators
- Agnes Flöel, Professor, Study chair, Charite Universitätsmedizin Berlin - Neurologie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01782391
- Sponsor's protocol ID
- Nighttime sleep-tSOS-MCI
- Status last verified
- May 2021
- First submitted
- 5 Jun 2012
- Last updated
- 24 May 2021
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Boggio PS, Khoury LP, Martins DC, Martins OE, de Macedo EC, Fregni F. Temporal cortex direct current stimulation enhances performance on a visual recognition memory task in Alzheimer disease. J Neurol Neurosurg Psychiatry. 2009 Apr;80(4):444-7. doi: 10.1136/jnnp.2007.141853. Epub 2008 Oct 31.
PubMed 18977813Marshall 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 17086200Diekelmann 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 20046194Ferrucci 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 18525028Naismith 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
Study at a glance
From the registry record, last updated by the sponsor on 24 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 Nocturnal Slow Wave Sleep in Patients With Mild Cognitive Impairments(MCI)
- ClinicalTrials.gov ID
- NCT01782391
- Acronym / sponsor ID
- Nighttime sleep-tSOS-MCI
- Conditions
- Mild Cognitive Impairment, So Stated
- Keywords
- mild cognitive impairment, dementia, MCI, brain stimulation, tSOS, tDCS, sleep, memory
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Lack of appropriate participants
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- 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.
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 patients with amnestic mild cognitive impairments (MCI)- usually characterized by initial difficulties in hippocampus dependent memory functions - 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 MCI patients.
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: Stimulationslow transcranial oscillating stimulation (~0,75Hz) during periods of Slow Wave Sleep |
| SHAM stimulation | Sham comparator | Device: SHAMSHAM stimulation during periods of Slow Wave Sleep |
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 |
|---|---|---|
| StimulationAlso: oscillating direct current brain stimulation | Device | 0,75 Hz stimulation |
| SHAMno stimulation | Device | SHAM 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 was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2021.
- Background: PubMed 18977813Boggio PS, Khoury LP, Martins DC, Martins OE, de Macedo EC, Fregni F. Temporal cortex direct current stimulation enhances performance on a visual recognition memory task in Alzheimer disease. J Neurol Neurosurg Psychiatry. 2009 Apr;80(4):444-7. doi: 10.1136/jnnp.2007.141853. Epub 2008 Oct 31.
- 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.
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 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: withdrawn, 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 was withdrawn before enrolling participants, so there are no results.
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 NCT01782391, 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.