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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Agnes Flöel, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT01888029
First received: June 25, 2013
Last updated: December 21, 2016
Last verified: December 2016
  Purpose
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 Intervention
Patients With Mild Cognitive Impairment Device: transcranial direct current stimulation Device: sham stimulation

Study Type: Interventional
Study Design: 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)

Further study details as provided by Agnes Flöel, Charite University, Berlin, Germany:

Primary Outcome Measures:
  • 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:
  • 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

  • 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)

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

  • 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


Estimated Enrollment: 15
Study Start Date: May 2013
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: October 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: transcranial direct current stimulation Device: transcranial direct current stimulation
Placebo Comparator: sham stimulation Device: sham stimulation

  Eligibility

Ages Eligible for Study:   50 Years to 80 Years   (Adult, Senior)
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01888029

Locations
Germany
Klinik und Poliklinik für Neurologie, Charité Universitätsmedizin Berlin
Berlin, Germany, 10117
Sponsors and Collaborators
Charite University, Berlin, Germany
  More Information

Responsible Party: Agnes Flöel, Prof. Dr., Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT01888029     History of Changes
Other Study ID Numbers: Plasticity in MCI
Study First Received: June 25, 2013
Last Updated: December 21, 2016

Keywords provided by Agnes Flöel, Charite University, Berlin, Germany:
mild cognitive impairment
Transcranial Direct Current Stimulation
Cortical Plasticity

Additional relevant MeSH terms:
Cognition Disorders
Mild Cognitive Impairment
Neurocognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on September 21, 2017