Mild Cognitive Impairment (MCI)NCT02110043
Modulation of Visual-Spatial Learning in Patients With Mild Cognitive Impairment (MCI) by tDCS
A study testing tDCS and training in people with Mild Cognitive Impairment (MCI), run by Charite University, Berlin, Germany at 1 site in Germany.
Trial summary
The aim of this study is to investigate whether a combination of intensive training of visual-spatial abilities (LOCATO task) with anodal transcranial direct current stimulation (tDCS) leads to an improvement in learning and memory in patients with mild cognitive impairment (MCI) and to examine the underlying neuronal… Read more about this study
- Who is it for?
- Ages 50 to 90 years
- Conditions the study is for
- Mild Cognitive Impairment (MCI)
- What is being tested?
- tDCS and training
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 21 participants
- Where
- 1 siteGermany
- Study dates
- Mar 2014to Oct 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
- right handedness
- amnestic and amnestic plus MCI with:
- subjective memory impairment;
- objective memory difficulties, at least 1 SD below gender, age and education adjusted standard values;
- relatively normal performance in other cognitive domains;
- no constraints in activities of daily livings
- age: 50-90 years
Who cannot join
- severe internal or psychiatric disease
- epilepsy
- other severe neurological diseases, e.g. previous major stroke or brain tumor
- DMS-IV manifest dementia
- contraindication for MRT (claustrophobia, metallic implants, tattoos)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Modulation of Visual-Spatial Learning in Patients With Mild Cognitive Impairment (MCI) by Transcranial Direct Current Stimulation - Proof of Principle and Mechanisms
The aim of this study is to investigate whether a combination of intensive training of visual-spatial abilities (LOCATO task) with anodal transcranial direct current stimulation (tDCS) leads to an improvement in learning and memory in patients with mild cognitive impairment (MCI) and to examine the underlying neuronal mechanism.
- Conditions
- Mild Cognitive Impairment (MCI)
- Being tested
- tDCS, training
- Keywords
- mild cognitive impairment (MCI), tDCS, LOCATO task, visual-spatial learning
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tDCSDevice
transcranial direct current stimulation (tDCS)
trainingBehavioural
intensive training of visual-spatial abilities (in LOCATO task)
| Study group | Role | What they receive |
|---|---|---|
| training + tDCS | Experimental | Combination of intensive training of visual-spatial abilities (LOCATO task) with anodal transcranial direct current stimulation (tDCS) Receives: Device: tDCS; Behavioral: training |
| training + sham stimulation | Sham comparator | Combination of intensive training of visual-spatial abilities (LOCATO task) with sham stimulation Receives: Device: tDCS; Behavioral: training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Performance in LOCATO task (Visual-spatial learning and memory) after a combination of intensive visual-spatial training and tDCS
Investigation whether the combination of intensive visual-spatial training (LOCATO task) and tDCS leads to improvement of visual-spatial learning and memory measured by performance in LOCATO task after end of a 3 day period of training compared to sham stimulation.
Measured: immediately after end of a 3-day period of training in tDCS condition vs sham condition
Secondary outcomes (7)
long term effects
long term effects measured by performance in LOCATO task in tDCS condition after end of cognitve training and after 1 month compared to control conditions
Measured: after 1 month vs baseline
functional changes: Connectivity
Connectivity (measured by resting-state fMRT and correlation analysis) at baseline compared to end of 3 day period of training
Measured: end of 3-day cognitive training vs baseline
cortical excitability
cortical excitability measured by transcranial magnetic stimulation (TMS)
Measured: at baseline
Quality of Life
quality of life as measured by standardized questionaire at baseline compared to quality of life measured 1 month after intervention (training and stimulation vs. training and sham-stimualtion)
Measured: after 1 month vs baseline
memory
memory performance tested at baseline compared to memory performance after the end of a 3-day cognitive training period and after 1 month (posttraining) in training and stimulation vs. training and sham stimulation
Measured: immediately after end of 3-day of cognitive training, after 1 month vs. baseline
affective state
affective state measured at baseline compared to affective state measured after the end of a 3-day cognitve training period and after 1 month (posttraining) in training and stimulation vs. training and sham stimulation
Measured: immediately after the end of 3-day cognitive training, after 1 month vs. baseline
genotyping of learning related polymorphisms
To assess predictors of positive reaction to brain stimulation, genotyping of several learning related polymorphisms will be performed (i.e., APOE, BDNF Val66Met, COMT Val158Met).
Measured: once
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2014 (estimated)
- Study startMar 2014
- Primary completionAug 2017
- Study completionOct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mild Cognitive Impairment (MCI)Studies 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
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 21 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, Prof. Dr., Principal investigator, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02110043
- Sponsor's protocol ID
- LOCATO-MCI-tDCS
- Status last verified
- May 2021
- First submitted
- 13 Feb 2014
- Last updated
- 21 May 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
Kulzow N, Kerti L, Witte VA, Kopp U, Breitenstein C, Floel A. An object location memory paradigm for older adults with and without mild cognitive impairment. J Neurosci Methods. 2014 Nov 30;237:16-25. doi: 10.1016/j.jneumeth.2014.08.020. Epub 2014 Aug 28.
PubMed 25176026
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modulation of Visual-Spatial Learning in Patients With Mild Cognitive Impairment (MCI) by Transcranial Direct Current Stimulation - Proof of Principle and Mechanisms
- ClinicalTrials.gov ID
- NCT02110043
- Acronym / sponsor ID
- LOCATO-MCI-tDCS
- Conditions
- Mild Cognitive Impairment (MCI)
- Keywords
- mild cognitive impairment (MCI), tDCS, LOCATO task, visual-spatial learning
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- Aug 2017 (actual)
- Study completion
- Oct 2017 (actual)
- First posted
- 10 Apr 2014 (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 aim of this study is to investigate whether a combination of intensive training of visual-spatial abilities (LOCATO task) with anodal transcranial direct current stimulation (tDCS) leads to an improvement in learning and memory in patients with mild cognitive impairment (MCI) and to examine the underlying neuronal mechanism.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| training + tDCS | Experimental | Device: tDCS, Behavioral: trainingCombination of intensive training of visual-spatial abilities (LOCATO task) with anodal transcranial direct current stimulation (tDCS) |
| training + sham stimulation | Sham comparator | Device: tDCS, Behavioral: trainingCombination of intensive training of visual-spatial abilities (LOCATO task) with sham stimulation |
Who may qualify
- Ages
- 50 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- right handedness
- amnestic and amnestic plus MCI with:
Key exclusion criteria (5 listed)
- severe internal or psychiatric disease
- epilepsy
- other severe neurological diseases, e.g. previous major stroke or brain tumor
- DMS-IV manifest dementia
- contraindication for MRT (claustrophobia, metallic implants, tattoos)
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 |
|---|---|---|
| tDCStranscranial direct current stimulation (tDCS) | Device | training + sham stimulation, training + tDCS |
| trainingintensive training of visual-spatial abilities (in LOCATO task) | Behavioural | training + sham stimulation, training + tDCS |
Primary outcome
Performance in LOCATO task (Visual-spatial learning and memory) after a combination of intensive visual-spatial training and tDCS
Time frame: immediately after end of a 3-day period of training in tDCS condition vs sham condition
Investigation whether the combination of intensive visual-spatial training (LOCATO task) and tDCS leads to improvement of visual-spatial learning and memory measured by performance in LOCATO task after end of a 3 day period of training compared to sham stimulation.
7 secondary outcomes
long term effects
Time frame: after 1 month vs baseline
functional changes: Connectivity
Time frame: end of 3-day cognitive training vs baseline
cortical excitability
Time frame: at baseline
Quality of Life
Time frame: after 1 month vs baseline
memory
Time frame: immediately after end of 3-day of cognitive training, after 1 month vs. baseline
affective state
Time frame: immediately after the end of 3-day cognitive training, after 1 month vs. baseline
genotyping of learning related polymorphisms
Time frame: once
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 21 May 2021.
- Background: PubMed 25176026Kulzow N, Kerti L, Witte VA, Kopp U, Breitenstein C, Floel A. An object location memory paradigm for older adults with and without mild cognitive impairment. J Neurosci Methods. 2014 Nov 30;237:16-25. doi: 10.1016/j.jneumeth.2014.08.020. Epub 2014 Aug 28.
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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, Prof. Dr. principal investigator
Charite University, Berlin, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing tDCS and training in people with Mild Cognitive Impairment (MCI), 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 7 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 21 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?
Performance in LOCATO task (Visual-spatial learning and memory) after a combination of intensive visual-spatial training and tDCS (time frame: immediately after end of a 3-day period of training in tDCS condition vs sham condition). 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 NCT02110043, which also lists 1 linked publication.
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 21 May 2021.