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

Primary Purpose

Dementia of Type Alzheimer

Status
Withdrawn
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
transcranial direct current stimulation
sham stimulation
Sponsored by
Charite University, Berlin, Germany
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dementia of Type Alzheimer focused on measuring cortical plasticity, transcranial direct current stimulation

Eligibility Criteria

50 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Klinik und Poliklinik für Neurologie, Charité Universitätsmedizin Berlin

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

transcranial direct current stimulation

sham stimulation

Arm Description

Outcomes

Primary Outcome Measures

the anodal transcranial direct current stimulation over the primary motor cortex (M1) in patients with dementia of Alzheimer type (DAT)
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

tDCS effects on central cholinergic activity in patients with DAT
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
tDCS-induced changes in learning success (performance in a motor learning paradigm in patients with DAT after tDCS vs. sham stimulation)
MR elastography
Comparison of viscoelastic parameters in cerebral MR elastography in patients with DAT
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

Full Information

First Posted
June 25, 2013
Last Updated
May 12, 2021
Sponsor
Charite University, Berlin, Germany
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1. Study Identification

Unique Protocol Identification Number
NCT01887899
Brief Title
Influence of tDCS on Cortical Plasticity in Patients With Dementia of the Alzheimer Type
Official Title
Influence of Transcranial Direct-current Stimulation on Cortical Plasticity in Patients With Dementia of the Alzheimer Type
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Withdrawn
Why Stopped
Not funded
Study Start Date
May 2013 (undefined)
Primary Completion Date
October 2017 (Anticipated)
Study Completion Date
December 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Charite University, Berlin, Germany

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dementia of Type Alzheimer
Keywords
cortical plasticity, transcranial direct current stimulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
transcranial direct current stimulation
Arm Type
Experimental
Arm Title
sham stimulation
Arm Type
Placebo Comparator
Intervention Type
Device
Intervention Name(s)
transcranial direct current stimulation
Intervention Type
Device
Intervention Name(s)
sham stimulation
Primary Outcome Measure Information:
Title
the anodal transcranial direct current stimulation over the primary motor cortex (M1) in patients with dementia of Alzheimer type (DAT)
Description
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
Time Frame
1 week
Secondary Outcome Measure Information:
Title
tDCS effects on central cholinergic activity in patients with DAT
Description
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
Time Frame
1 week
Title
tDCS effects on learning
Description
tDCS-induced changes in learning success (performance in a motor learning paradigm in patients with DAT after tDCS vs. sham stimulation)
Time Frame
1 week
Title
MR elastography
Description
Comparison of viscoelastic parameters in cerebral MR elastography in patients with DAT
Time Frame
1 week
Title
genetic polymorphism, ApoE4
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Facility Information:
Facility Name
Klinik und Poliklinik für Neurologie, Charité Universitätsmedizin Berlin
City
Berlin
ZIP/Postal Code
10117
Country
Germany

12. IPD Sharing Statement

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

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