- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01888029
Influence of tDCS on Cortical Plasticity in Patients With Mild Cognitive Impairment (MCI)
May 12, 2021 updated by: Agnes Flöel, Charite University, Berlin, Germany
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).
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
Study Type
Interventional
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Berlin, Germany, 10117
- Klinik und Poliklinik für Neurologie, Charité Universitätsmedizin Berlin
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
50 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: transcranial direct current stimulation
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Placebo Comparator: sham stimulation
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
1 week
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
genetic polymorphism, ApoE4
Time Frame: once
|
optional assessment of genetic Apo4 epsilon status for assessment of differences in cortical plasticity and elasticity between Apo4 epsilon positive and negative participants
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once
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Comparison of tDCS-induced changes on central cholinergic activity
Time Frame: 1 week
|
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
|
1 week
|
Comparison of tDCS-induced changes in learning success
Time Frame: 1 week
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tDCS-induced changes in learning success (performance in a motor learning paradigm in patients with MCI after tDCS vs. sham stimulation)
|
1 week
|
MR elastography
Time Frame: 1 week
|
Comparison of viscoelastic parameters in cerebral MR elastography in patients with MCI
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1 week
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2013
Primary Completion (Anticipated)
October 1, 2017
Study Completion (Anticipated)
December 1, 2017
Study Registration Dates
First Submitted
June 25, 2013
First Submitted That Met QC Criteria
June 25, 2013
First Posted (Estimate)
June 27, 2013
Study Record Updates
Last Update Posted (Actual)
May 14, 2021
Last Update Submitted That Met QC Criteria
May 12, 2021
Last Verified
May 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Plasticity in MCI
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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