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

• ClinicalTrials.gov Identifier: NCT01888029
• Recruitment Status: Withdrawn
• First Posted: June 27, 2013
• Last Update Posted: May 14, 2021
• Sponsor: Charite University, Berlin, Germany
• Information provided by (Responsible Party): Agnes Flöel, Charite University, Berlin, Germany

Tracking Information

• First Submitted Date: June 25, 2013
• First Posted Date: June 27, 2013
• Last Update Posted Date: May 14, 2021
• Study Start Date: May 2013
• Estimated Primary Completion Date: October 2017 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current

Current Secondary Outcome Measures (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 (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: Influence of tDCS on Cortical Plasticity in Patients With Mild Cognitive Impairment (MCI)
• Official Title: 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment
• Condition: Patients With Mild Cognitive Impairment

Intervention

• Device: transcranial direct current stimulation
• Device: sham stimulation

Study Arms

• Experimental: transcranial direct current stimulation
  Intervention: Device: transcranial direct current stimulation
• Placebo Comparator: sham stimulation
  Intervention: Device: sham stimulation

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Withdrawn
• Actual Enrollment (submitted: May 12, 2021): 0
• Original Estimated Enrollment (submitted: June 25, 2013): 15
• Estimated Study Completion Date: December 2017
• Estimated Primary Completion Date: October 2017 (Final data collection date for primary outcome measure)

Eligibility 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)

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 50 Years to 80 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Germany

Administrative Information

• NCT Number: NCT01888029
• Other Study ID Numbers: Plasticity in MCI
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Agnes Flöel, Charite University, Berlin, Germany
• Study Sponsor: Charite University, Berlin, Germany
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Charite University, Berlin, Germany
• Verification Date: May 2021