Mild Cognitive ImpairmentMICENCT02940457
Cognitive Ability Training for Seniors With Mild Cognitive Impairment
A study testing Verum tDCS in people with Mild Cognitive Impairment, run by Wuerzburg University Hospital at 1 site in Germany.
Trial summary
This study investigates the beneficial effects of prefrontal brain stimulation (with transcranial direct current stimulation [tDCS]) during working memory training in seniors with mild cognitive impairments.The placebo-controlled double blinded study includes 50 elderly patients which will be randomized into verum or… Read more about this study
- Who is it for?
- Ages 50 to 75 years
- Conditions the study is for
- Mild Cognitive Impairment
- What is being tested?
- Verum tDCS
- 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
- 1 Nov 2017to Dec 2020
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- suspected MCI
- total CERAD score <= 85.1
- MMSE >=24
- native german speaker
- between 50-75 years old
- right handed
Who cannot join
- impairment of daily living activities
- psychiatric, neurological diseases
- uncorrected hearing or vision deficits
- actual psychopharmaca intake
- metal parts in the head
- medical electronical implants
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Verbesserung Kognitiver Fähigkeiten Bei Personen Mit Verdacht Auf Eine Leichte Kognitive Beeinträchtigung
This study investigates the beneficial effects of prefrontal brain stimulation (with transcranial direct current stimulation [tDCS]) during working memory training in seniors with mild cognitive impairments.The placebo-controlled double blinded study includes 50 elderly patients which will be randomized into verum or sham tDCS.
Read the detailed description
In this project, we want to test whether the effectiveness of neuropsychological exercise therapy can be increased in elderly persons suspected of having an MCI by means of parallel tDCS treatment.
All test participants train over 6 sessions within 2 weeks two different working memory tasks with increasing difficulty. In the randomized, double-blind, prospective therapy study, participants are assigned to either a Verum-tDCS or a placebo-tDCS group. The Verum-tDCS group receives active stimulation in parallel to the exercise therapy, while the placebo group does not receive tDCS stimulation. To check the effects of the therapy, we measure performance and neuronal activation in different executive tasks using near-infrared spectroscopy (NIRS). Furthermore, we will check whether the training increases the volume of the grey matter (Draganski et al., 2004, Malchow et al., 2016) and the expression of BDNF can be increased (Schuch et al., 2015).
- Conditions
- Mild Cognitive Impairment
- Being tested
- Verum tDCS, Sham tDCS
- Keywords
- tDCS, MCI, Working Memory, fNIRS
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Verum tDCSDevice
Neuropsychological (working memory) training for 30 minutes, 6 sessions tDCS during training with 2 mA
Sham tDCSDevice
Neuropsychological (working memory) training for 30 minutes, 6 sessions tDCS during training with 0 mA
| Study group | Role | What they receive |
|---|---|---|
| Verum tDCS | Experimental | prefrontal anodal stimulation Receives: Device: Verum tDCS |
| Sham tDCS | Experimental | sham stimulation, same electrode positions Receives: Device: Sham tDCS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brain activation measured with NIRS
The Investigators are measuring brain activation during executive functions
Measured: 4 weeks
Reaction times, errors and number of generated words in neuropsychological tasks
The Investigators are measuring cognitive performance for different executive functions
Measured: 4 weeks
Secondary outcomes (2)
T1 weighted magnetic resonance Imaging (MRI) of the brain
Structural changes in grey matter of the brain calculated by voxel based morphometry (VBM)
Measured: 4 weeks
Blood sampling
Increased BDNF secretion in serum
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 posted21 Oct 2016 (estimated)
- Study start1 Nov 2017
- Primary completionDec 2020 (estimated)
- Study completionDec 2020 (estimated)
Why it stopped: The employe for the study quit and a new grant proposal was not financed
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
- 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wuerzburg University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Martin Herrmann, Principal investigator, Wuerzburg University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02940457
- Sponsor's protocol ID
- Wuerzburg165/16
- Acronym
- MICE
- Status last verified
- Apr 2019
- First submitted
- 11 Oct 2016
- Last updated
- 26 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Verbesserung Kognitiver Fähigkeiten Bei Personen Mit Verdacht Auf Eine Leichte Kognitive Beeinträchtigung
- ClinicalTrials.gov ID
- NCT02940457
- Acronym / sponsor ID
- MICE / Wuerzburg165/16
- Conditions
- Mild Cognitive Impairment
- Keywords
- tDCS, MCI, Working Memory, fNIRS
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The employe for the study quit and a new grant proposal was not financed
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Wuerzburg University HospitalUniversity, hospital or other
- Study start
- 1 Nov 2017 (actual)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 21 Oct 2016 (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.
This study investigates the beneficial effects of prefrontal brain stimulation (with transcranial direct current stimulation [tDCS]) during working memory training in seniors with mild cognitive impairments.The placebo-controlled double blinded study includes 50 elderly patients which will be randomized into verum or sham tDCS.
Detailed description
In this project, we want to test whether the effectiveness of neuropsychological exercise therapy can be increased in elderly persons suspected of having an MCI by means of parallel tDCS treatment.
All test participants train over 6 sessions within 2 weeks two different working memory tasks with increasing difficulty. In the randomized, double-blind, prospective therapy study, participants are assigned to either a Verum-tDCS or a placebo-tDCS group. The Verum-tDCS group receives active stimulation in parallel to the exercise therapy, while the placebo group does not receive tDCS stimulation. To check the effects of the therapy, we measure performance and neuronal activation in different executive tasks using near-infrared spectroscopy (NIRS). Furthermore, we will check whether the training increases the volume of the grey matter (Draganski et al., 2004, Malchow et al., 2016) and the expression of BDNF can be increased (Schuch et al., 2015).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Verum tDCS | Experimental | Device: Verum tDCSprefrontal anodal stimulation |
| Sham tDCS | Experimental | Device: Sham tDCSsham stimulation, same electrode positions |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- suspected MCI
- total CERAD score <= 85.1
- MMSE >=24
- native german speaker
- between 50-75 years old
Key exclusion criteria (6 listed)
- impairment of daily living activities
- psychiatric, neurological diseases
- uncorrected hearing or vision deficits
- actual psychopharmaca intake
- metal parts in the head
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 |
|---|---|---|
| Verum tDCSNeuropsychological (working memory) training for 30 minutes, 6 sessions tDCS during training with 2 mA | Device | Verum tDCS |
| Sham tDCSNeuropsychological (working memory) training for 30 minutes, 6 sessions tDCS during training with 0 mA | Device | Sham tDCS |
Primary outcome
Brain activation measured with NIRS
Time frame: 4 weeks
The Investigators are measuring brain activation during executive functions
Reaction times, errors and number of generated words in neuropsychological tasks
Time frame: 4 weeks
The Investigators are measuring cognitive performance for different executive functions
2 secondary outcomes
T1 weighted magnetic resonance Imaging (MRI) of the brain
Time frame: 4 weeks
Blood sampling
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 26 May 2020.
- Individual participant dataSharing planned: No
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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.
Martin Herrmann principal investigator
Wuerzburg University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Verum tDCS in people with Mild Cognitive Impairment, run by Wuerzburg University Hospital 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 6 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 26 May 2020. 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. 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?
Brain activation measured with NIRS (time frame: 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 May 2020.