Patients With Mild Cognitive ImpairmentNCT01888029
Influence of tDCS on Cortical Plasticity in Patients With Mild Cognitive Impairment (MCI)
A study testing transcranial direct current stimulation in people with Patients With Mild Cognitive Impairment, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial summary
The aim of this study is to investigate whether the anodal transcranial direct current stimulation (tDCS) over the primary motor cortex (M1) in patients with mild cognitive impairment (MCI) leads to an increase in cortical plasticity (change in motor evoked potentials (MEP) in mV). Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Patients With Mild Cognitive Impairment
- What is being tested?
- transcranial direct current 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
- May 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Right-handed according to the Oldfield Händigkeits inventory (lateralization index> 70) (1971)
- Cognitive impairment according to the diagnostic criteria of a MCI (amnesic or even multiple domains)
- No therapeutic treatment with AChE inhibitors
- No motor impairments relevant to everyday life
- Age 50 to 80 years
Who cannot join
- Severe neurological / psychiatric or pre-existing internist conditions because additional cognitive deficits are expected
- Epilepsy, epileptic seizure in medical history
- Cognitive deficit (MMSE <20)
- Depressive episode (Beck Depression Inventory (BDI)> 12)
- Newly taking (<3 months) centrally active drugs, particularly acetylcholinesterase inhibitors
- Pregnancy
- Pacemaker (contraindication for MRI)
- Other metal parts in the body (contraindication for MRI)
Trial locations and contacts
1 site in 1 country.
Germany1 site
Klinik und Poliklinik für Neurologie, Charité Universitätsmedizin Berlin
Berlin, 10117
About this study
Official title: Influence of Transcranial Direct Current Stimulation on Cortical Plasticity in Patients With Mild Cognitive Impairment (MCI)
The aim of this study is to investigate whether the anodal transcranial direct current stimulation (tDCS) over the primary motor cortex (M1) in patients with mild cognitive impairment (MCI) leads to an increase in cortical plasticity (change in motor evoked potentials (MEP) in mV).
- Conditions
- Patients With Mild Cognitive Impairment
- Being tested
- transcranial direct current stimulation, sham stimulation
- Keywords
- mild cognitive impairment, Transcranial Direct Current Stimulation, Cortical Plasticity
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sham stimulationDevice
| Study group | Role | What they receive |
|---|---|---|
| transcranial direct current stimulation | Experimental | Not described Receives: Device: transcranial direct current stimulation |
| sham stimulation | Placebo comparator | Not described Receives: Device: sham stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
the anodal transcranial direct current stimulation over the primary motor cortex (M1) in patients with mild cognitive impairment (MCI)
to investigate whether the anodal transcranial direct current stimulation over the primary motor cortex (M1) in patients with mild cognitive impairment (MCI) increases cortical plasticity (measured via motor evoked potentials) compared to sham stimulation
Measured: 1 week
Secondary outcomes (4)
Comparison of tDCS-induced changes on central cholinergic activity
to investigate weather the anodal transcranial direct current stimulation affect central cholinergic activity (measured via a TMS protocol) in MCI patients compared to sham stimulation
Measured: 1 week
Comparison of tDCS-induced changes in learning success
tDCS-induced changes in learning success (performance in a motor learning paradigm in patients with MCI after tDCS vs. sham stimulation)
Measured: 1 week
MR elastography
Comparison of viscoelastic parameters in cerebral MR elastography in patients with MCI
Measured: 1 week
genetic polymorphism, ApoE4
optional assessment of genetic Apo4 epsilon status for assessment of differences in cortical plasticity and elasticity between Apo4 epsilon positive and negative participants
Measured: once
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2013 (estimated)
- Study startMay 2013
- Primary completionOct 2017 (estimated)
- Study completionDec 2017 (estimated)
Why it stopped: Not funded
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients With Mild Cognitive ImpairmentStudies 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01888029
- Sponsor's protocol ID
- Plasticity in MCI
- Status last verified
- May 2021
- First submitted
- 25 Jun 2013
- Last updated
- 14 May 2021
- Results posted
- No
- Data monitoring committee
- No
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
- Influence of Transcranial Direct Current Stimulation on Cortical Plasticity in Patients With Mild Cognitive Impairment (MCI)
- ClinicalTrials.gov ID
- NCT01888029
- Acronym / sponsor ID
- Plasticity in MCI
- Conditions
- Patients With Mild Cognitive Impairment
- Keywords
- mild cognitive impairment, Transcranial Direct Current Stimulation, Cortical Plasticity
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Not funded
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- Oct 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 27 Jun 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 aim of this study is to investigate whether the anodal transcranial direct current stimulation (tDCS) over the primary motor cortex (M1) in patients with mild cognitive impairment (MCI) leads to an increase in cortical plasticity (change in motor evoked potentials (MEP) in mV).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| transcranial direct current stimulation | Experimental | Device: transcranial direct current stimulation |
| sham stimulation | Placebo comparator | Device: sham stimulation |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Right-handed according to the Oldfield Händigkeits inventory (lateralization index> 70) (1971)
- Cognitive impairment according to the diagnostic criteria of a MCI (amnesic or even multiple domains)
- No therapeutic treatment with AChE inhibitors
- No motor impairments relevant to everyday life
- Age 50 to 80 years
Key exclusion criteria (8 listed)
- Severe neurological / psychiatric or pre-existing internist conditions because additional cognitive deficits are expected
- Epilepsy, epileptic seizure in medical history
- Cognitive deficit (MMSE <20)
- Depressive episode (Beck Depression Inventory (BDI)> 12)
- Newly taking (<3 months) centrally active drugs, particularly acetylcholinesterase inhibitors
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 |
|---|---|---|
| transcranial direct current stimulation | Device | transcranial direct current stimulation |
| sham stimulation | Device | sham stimulation |
Primary outcome
the anodal transcranial direct current stimulation over the primary motor cortex (M1) in patients with mild cognitive impairment (MCI)
Time frame: 1 week
to investigate whether the anodal transcranial direct current stimulation over the primary motor cortex (M1) in patients with mild cognitive impairment (MCI) increases cortical plasticity (measured via motor evoked potentials) compared to sham stimulation
4 secondary outcomes
Comparison of tDCS-induced changes on central cholinergic activity
Time frame: 1 week
Comparison of tDCS-induced changes in learning success
Time frame: 1 week
MR elastography
Time frame: 1 week
genetic polymorphism, ApoE4
Time frame: once
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 14 May 2021.
Related trials for Patients With Mild Cognitive Impairment
Enrolling by invitationPhase 2
Tau PET Outcomes With Anti-amyloid Immunotherapies
Cognitive Impairment, Mild, Dementia, Mild
RecruitingPhase 1
A First-In-Human Study of LY3954068 in Participants With Early Symptomatic Alzheimer's Disease
Alzheimer Disease
RecruitingObservational study
Loneliness as Risk Factor for Dementia
Mild Cognitive Impairment (MCI), Dementia (Diagnosis)
Not yet recruitingPhase 2
Effects of Tadalafil on Cognition and Cerebral Hemodynamics in Elderly Patients With Mild Cognitive Impairment
Mild Cognitive Impairment (MCI)
Recruiting
CMN LIFU for Enhanced Glymphatic Clearance in Amyloid-Positive MCI
Alzheimer's Disease (AD), Mild Cognitive Impairment (MCI)
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing transcranial direct current stimulation in people with Patients With Mild Cognitive Impairment, 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 5 inclusion and 8 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 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 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?
the anodal transcranial direct current stimulation over the primary motor cortex (M1) in patients with mild cognitive impairment (MCI) (time frame: 1 week). 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 14 May 2021.