Influence of tDCS on Cortical Plasticity in Patients With Dementia of the Alzheimer Type

Not Applicable

Withdrawn

• Conditions: Dementia of Type Alzheimer
• Interventions: Device: transcranial direct current stimulation; Device: sham stimulation

• Registration Number: NCT01887899
• 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 dementia of the Alzheimer type (DAT) 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• Status: WITHDRAWN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, which corresponds to a mild to moderate DAT
• No treatment with AChE inhibitors, or existing stable treatment with AChE inhibitors for over 3 months
• No motor impairments relevant to everyday life
• Age 50 to 80 years
• Existing Insurance certificate
• Existing informed consent

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)
• intake of centrally active drugs <3 months, particularly acetylcholinesterase inhibitors
• Pregnancy
• Pacemaker (contraindication for MRI)
• Other metal parts in the body (contraindication for MRI)

Exclusion Criteria

Not provided

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 dementia of Alzheimer type (DAT)	1 week	to investigate whether the anodal transcranial direct current stimulation over the primary motor cortex (M1) in patients with dementia of Alzheimer type (DAT) increases cortical plasticity (measured via motor evoked potentials) compared to a sham stimulation

Secondary Outcome Measures

Name	Time	Method
tDCS effects on central cholinergic activity in patients with DAT	1 week	to investigate whether the anodal transcranial direct current stimulation affect central cholinergic activity (measured via a TMS-protocol) in patients with dementia of Alzheimer type (DAT) compared to a sham stimulation
tDCS effects on learning	1 week	tDCS-induced changes in learning success (performance in a motor learning paradigm in patients with DAT after tDCS vs. sham stimulation)
MR elastography	1 week	Comparison of viscoelastic parameters in cerebral MR elastography in patients with DAT
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