Study Stopped
Not funded
Influence of tDCS on Cortical Plasticity in Patients With Dementia of the Alzheimer Type
Influence of Transcranial Direct-current Stimulation on Cortical Plasticity in Patients With Dementia of the Alzheimer Type
1 other identifier
interventional
N/A
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started May 2013
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2013
CompletedFirst Submitted
Initial submission to the registry
June 25, 2013
CompletedFirst Posted
Study publicly available on registry
June 27, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2017
CompletedMay 14, 2021
May 1, 2021
4.4 years
June 25, 2013
May 12, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
1 week
Secondary Outcomes (4)
tDCS effects on central cholinergic activity in patients with DAT
1 week
tDCS effects on learning
1 week
MR elastography
1 week
genetic polymorphism, ApoE4
once
Study Arms (2)
transcranial direct current stimulation
EXPERIMENTALsham stimulation
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Klinik und Poliklinik für Neurologie, Charité Universitätsmedizin Berlin
Berlin, 10117, Germany
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Prof. Dr.
Study Record Dates
First Submitted
June 25, 2013
First Posted
June 27, 2013
Study Start
May 1, 2013
Primary Completion
October 1, 2017
Study Completion
December 1, 2017
Last Updated
May 14, 2021
Record last verified: 2021-05