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WithdrawnNCT01888029Updated May 14, 2021

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

An interventional study of transcranial direct current stimulation and sham stimulation in Patients With Mild Cognitive Impairment, sponsored by Charite University, Berlin, Germany. Withdrawn at 1 site in Germany. Open to participants aged 50 Years to 80 Years. Per ClinicalTrials.gov, last updated 2021-05-14.

Sponsored by Charite University, Berlin, Germany · Not applicable, Interventional, and Treatment

Why this study was withdrawn
Not funded
Phase
Not applicable
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
50 Years to 80 Years
Sex
All
01

Study 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).

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Conditions studied

  • Patients With Mild Cognitive Impairment

Keywords

  • mild cognitive impairment
  • Transcranial Direct Current Stimulation
  • Cortical Plasticity
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In context

Cognitive Dysfunction

3,843 studies on the registry are indexed under Cognitive Dysfunction; 1,099 are open to participants now.

Browse Cognitive Dysfunction studies →

Lead sponsor

Charite University, Berlin, Germany is the lead sponsor of 836 studies on the registry; 129 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
50 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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)
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    transcranial direct current stimulation

    Device: transcranial direct current stimulation

  • Placebo comparator
    sham stimulation

    Device: sham stimulation

Interventions

  • Devicetranscranial direct current stimulation
  • Devicesham stimulation
06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 1 week

Secondary outcomes

  1. 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

    Time frame: 1 week

  2. 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)

    Time frame: 1 week

  3. MR elastography

    Comparison of viscoelastic parameters in cerebral MR elastography in patients with MCI

    Time frame: 1 week

  4. 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

    Time frame: once

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Study locations

1 site
  • Klinik und Poliklinik für Neurologie, Charité Universitätsmedizin Berlin
    Berlin, 10117, Germany
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 14, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01888029
Lead sponsor
Charite University, Berlin, Germany
Responsible party
Agnes Flöel (Prof. Dr., Charite University, Berlin, Germany) — Principal investigator
First posted
Jun 27, 2013
Start date
May 2013
Primary completion
Oct 2017 (estimated)
Completion
Dec 2017 (estimated)
Last update
May 14, 2021

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is withdrawn, as verified in May 2021. You cannot join it, but the record below documents what was studied.

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