Dementia of Type Alzheimer Clinical Trial
Official title:
Influence of Transcranial Direct-current Stimulation on Cortical Plasticity in Patients With Dementia of the Alzheimer Type
| Verified date | May 2021 |
| Source | Charite University, Berlin, Germany |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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).
| Status | Withdrawn |
| Enrollment | 0 |
| Est. completion date | December 2017 |
| Est. primary completion date | October 2017 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 50 Years to 80 Years |
| Eligibility | 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) |
| Country | Name | City | State |
|---|---|---|---|
| Germany | Klinik und Poliklinik für Neurologie, Charité Universitätsmedizin Berlin | Berlin |
| Lead Sponsor | Collaborator |
|---|---|
| Charite University, Berlin, Germany |
Germany,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | 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 | 1 week | |
| Secondary | 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) | 1 week | |
| Secondary | MR elastography | Comparison of viscoelastic parameters in cerebral MR elastography in patients with DAT | 1 week | |
| Secondary | 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 | once |