Influence of Transcranial Direct-current Stimulation on Cortical Plasticity in Patients With Dementia of the Alzheimer Type
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Locations
- 2
- Primary Endpoint
- the anodal transcranial direct current stimulation over the primary motor cortex (M1) in patients with dementia of Alzheimer type (DAT)
Study Overview
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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 50 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
the anodal transcranial direct current stimulation over the primary motor cortex (M1) in patients with dementia of Alzheimer type (DAT)
Time Frame: 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 Outcomes
- 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)
Investigators
Agnes Flöel
Prof. Dr.
Charite University, Berlin, Germany