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

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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Recruitment Status : Withdrawn (Not funded)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

Tracking Information
First Submitted Date  ICMJE June 25, 2013
First Posted Date  ICMJE June 27, 2013
Last Update Posted Date May 14, 2021
Study Start Date  ICMJE May 2013
Estimated Primary Completion Date October 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 25, 2013)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 13, 2014)
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: June 25, 2013)
  • 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)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Influence of tDCS on Cortical Plasticity in Patients With Mild Cognitive Impairment (MCI)
Official Title  ICMJE Influence of Transcranial Direct Current Stimulation on Cortical Plasticity in Patients With Mild Cognitive Impairment (MCI)
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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Patients With Mild Cognitive Impairment
Intervention  ICMJE
  • Device: transcranial direct current stimulation
  • Device: sham stimulation
Study Arms  ICMJE
  • Experimental: transcranial direct current stimulation
    Intervention: Device: transcranial direct current stimulation
  • Placebo Comparator: sham stimulation
    Intervention: Device: sham stimulation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: May 12, 2021)
0
Original Estimated Enrollment  ICMJE
 (submitted: June 25, 2013)
15
Estimated Study Completion Date  ICMJE December 2017
Estimated Primary Completion Date October 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01888029
Other Study ID Numbers  ICMJE Plasticity in MCI
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Agnes Flöel, Charite University, Berlin, Germany
Study Sponsor  ICMJE Charite University, Berlin, Germany
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Charite University, Berlin, Germany
Verification Date May 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP