Patients With Mild Cognitive Impairment Clinical Trial
Official title:
Influence of Transcranial Direct Current Stimulation on Cortical Plasticity in Patients With Mild Cognitive Impairment (MCI)
| 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 mild cognitive impairment (MCI) 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| Status | Withdrawn |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 according to the diagnostic criteria of a MCI (amnesic or even multiple domains) - No therapeutic treatment with AChE inhibitors - No motor impairments relevant to everyday life - Age 50 to 80 years 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) - Newly taking (<3 months) centrally active drugs, 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 mild cognitive impairment (MCI) | to investigate whether the anodal transcranial direct current stimulation over the primary motor cortex (M1) in patients with mild cognitive impairment (MCI) increases cortical plasticity (measured via motor evoked potentials) compared to sham stimulation | 1 week | |
| Secondary | Comparison of tDCS-induced changes on central cholinergic activity | to investigate weather the anodal transcranial direct current stimulation affect central cholinergic activity (measured via a TMS protocol) in MCI patients compared to sham stimulation | 1 week | |
| Secondary | Comparison of tDCS-induced changes in learning success | tDCS-induced changes in learning success (performance in a motor learning paradigm in patients with MCI after tDCS vs. sham stimulation) | 1 week | |
| Secondary | MR elastography | Comparison of viscoelastic parameters in cerebral MR elastography in patients with MCI | 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 |