Mild Cognitive Impairment Clinical Trial
Official title:
The Effect of Transcranial Direct Current Stimulation on Visual Attention in Mild Cognitive Impairment - a Combined MRI and Non-invasive Brain Stimulation Study
Verified date | September 2021 |
Source | Masaryk University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Progressively causes the breakdown of cognitive functions and impairs quality of life for patients and their caregivers. In addition to memory impairment, visual attention is also compromised, even at the stage of mild cognitive impairment due to AD (MCI-AD). No treatment has been found for MCI-AD; therefore, attention has been drawn to non-invasive brain stimulation techniques, such as transcranial direct current stimulation (tDCS), in order to enhance cognitive functions by modifying brain plasticity. In the current research, investigator aim to examine the long-term effects of the optimal multiple-session tDCS protocol in MCI-AD on visual attention including the transfer to an ecologically valid virtual environment and identify the neural underpinnings of tDCS-induced behavioral aftereffects using a combined tDCS/ MRI network-based approach.
Status | Completed |
Enrollment | 35 |
Est. completion date | December 30, 2022 |
Est. primary completion date | October 30, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 60 Years to 85 Years |
Eligibility | Inclusion Criteria: - amnestic single or multi-domain mild cognitive impairment patients in accordance with diagnostic criteria (Albert et al., 2011) Exclusion Criteria: - psychiatric disorders, including major depression, major vascular lesions, and other brain pathologies detected by MRI that might present with cognitive decline - a cardio pacemaker or any MRI-incompatible metal in the body - epilepsy - any diagnosed psychiatric disorder - alcohol/drug abuse - lack of cooperation - presence of dementia. |
Country | Name | City | State |
---|---|---|---|
Czechia | Ceitec, Masaryk University | Brno |
Lead Sponsor | Collaborator |
---|---|
Masaryk University | St. Anne's University Hospital Brno, Czech Republic |
Czechia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Memory task in virtual reality performance - the accuracy | Change from baseline immediately after completion of stimulation protocol and one month after completion of stimulation protocol | ||
Other | Memory task in virtual reality performance - The time to accomplish different difficulty levels | Change from baseline immediately after completion of stimulation protocol and one month after completion of stimulation protocol | ||
Other | Memory task in virtual reality performance - The trajectories needed for completion of different difficulty levels | Change from baseline immediately after completion of stimulation protocol and one month after completion of stimulation protocol | ||
Other | Visual working memory task accuracy | Task will be presented on a computer and subject will respond by YES-NO buttons. Only if there are no differences in task accuracy, we will measure task reaction times (e.g. due to the roof effect). | Change from baseline immediately after completion of stimulation protocol and one month after completion of stimulation protocol | |
Primary | Visual-attention task accuracy | Task will be presented on a computer and subject will respond by YES-NO buttons. Only if there are no differences in task accuracy, we will measure task reaction times (e.g. due to the roof effect). | Change from baseline immediately after completion of stimulation protocol and one month after completion of stimulation protocol | |
Secondary | Psychological assessment - z-score computed from multiple psychological domains | Z-scores based on neuropsychological assessment (lasting up to 40 min) evaluating (global cognitive functions, memory, attention, psychomotor functions, executive functions, visuospatial functions, language, depressive symptoms, and activities of daily living) Only if there are no changes in z-score, we will asses change on a level of individual tests. | Change from baseline immediately after one month from completion of stimulation protocol | |
Secondary | Magnetic resonance imaging | Investigator will record high resolution structural T1-weighted (MPRAGE) images, functional T2* weighted multiband EPI sequences, and DTI measurement. The total time spent in the scanner will be approximately 60 min | Change from baseline immediately after completion of stimulation protocol and one month after completion of stimulation protocol |
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