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

Not Applicable

Withdrawn

• Conditions: Patients With Mild Cognitive Impairment
• Interventions: Device: transcranial direct current stimulation; Device: sham stimulation

• Registration Number: NCT01888029
• Lead Sponsor: Charite University, Berlin, Germany

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 available

Study Timeline

• Study Start: 2013-05
• Study First Submitted: 2013-06-25
• Study First Submitted QC: 2013-06-25
• Study First Posted: 2013-06-27
• Primary Completion: 2017-10
• Study Completion: 2017-12
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-12
• Last Update Posted: 2021-05-14

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
transcranial direct current stimulation	transcranial direct current stimulation	-
sham stimulation	sham stimulation	-

Primary Outcome Measures

Name	Time	Method
the anodal transcranial direct current stimulation over the primary motor cortex (M1) in patients with mild cognitive impairment (MCI)	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

Name	Time	Method
Comparison of tDCS-induced changes on central cholinergic activity	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	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	1 week	Comparison of viscoelastic parameters in cerebral MR elastography in patients with MCI
genetic polymorphism, ApoE4	once	optional assessment of genetic Apo4 epsilon status for assessment of differences in cortical plasticity and elasticity between Apo4 epsilon positive and negative participants

Trial Locations

Locations (1)

Klinik und Poliklinik für Neurologie, Charité Universitätsmedizin Berlin; 🇩🇪 Berlin, Germany