We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Influence of tDCS on Cortical Plasticity in Patients With Mild Cognitive Impairment (MCI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01888029
Recruitment Status : Withdrawn (Not funded)
First Posted : June 27, 2013
Last Update Posted : May 14, 2021
Sponsor:
Information provided by (Responsible Party):
Agnes Flöel, Charite University, Berlin, Germany

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief 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).

Condition or disease Intervention/treatment Phase
Patients With Mild Cognitive Impairment Device: transcranial direct current stimulation Device: sham stimulation Not Applicable

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Influence of Transcranial Direct Current Stimulation on Cortical Plasticity in Patients With Mild Cognitive Impairment (MCI)
Study Start Date : May 2013
Estimated Primary Completion Date : October 2017
Estimated Study Completion Date : December 2017
Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: transcranial direct current stimulation Device: transcranial direct current stimulation
Placebo Comparator: sham stimulation Device: sham stimulation


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. Comparison of tDCS-induced changes in learning success [ Time Frame: 1 week ]
    tDCS-induced changes in learning success (performance in a motor learning paradigm in patients with MCI after tDCS vs. sham stimulation)

  3. MR elastography [ Time Frame: 1 week ]
    Comparison of viscoelastic parameters in cerebral MR elastography in patients with MCI

  4. 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


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   50 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01888029


Locations
Layout table for location information
Germany
Klinik und Poliklinik für Neurologie, Charité Universitätsmedizin Berlin
Berlin, Germany, 10117
Sponsors and Collaborators
Charite University, Berlin, Germany
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Agnes Flöel, Prof. Dr., Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT01888029    
Other Study ID Numbers: Plasticity in MCI
First Posted: June 27, 2013    Key Record Dates
Last Update Posted: May 14, 2021
Last Verified: May 2021
Keywords provided by Agnes Flöel, Charite University, Berlin, Germany:
mild cognitive impairment
Transcranial Direct Current Stimulation
Cortical Plasticity
Additional relevant MeSH terms:
Layout table for MeSH terms
Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Mental Disorders