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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04134195
Other study ID # NV18-04-00256-single
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 19, 2020
Est. completion date December 30, 2020

Study information

Verified date September 2020
Source Masaryk University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Recently, 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 and use it in different healthy and diseased populations. In the current research, investigator aim to examine the short-term effects of multiple tDCS protocols in healthy adults population on visual attention and identify the neural underpinnings of tDCS-induced behavioral aftereffects using a combined tDCS/ MRI network-based approach.


Description:

Investigator will investigate the shor-term effects of active tDCS as compared to a placebo stimulation on visual attention in the healthy seniors. A cross-over, randomized, placebo-controlled design will be used. Single tDCS sessions will be performed in 4 sessions over distinct brain areas with ongoing visual attention training. During the stimulation, investigator will use the visual matching task. MRI protocol consisting of T1 and resting state fMRI sequences will be acquired before and after every stimulation session in order to search for active vs. placebo tDCS-induced changes in brain activation and resting state functional connectivity and to identify neural correlates of behavioral changes.


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date December 30, 2020
Est. primary completion date March 30, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria: - right handed, healthy volunteers in two groups - healthy adults under 40 years, healthy seniors over 50 years 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 cognitive impairment

Study Design


Intervention

Device:
Transcranial direct current stimulation
2mA stimulation for 20 minutes

Locations

Country Name City State
Czechia Ceitec, Masaryk University Brno

Sponsors (2)

Lead Sponsor Collaborator
Masaryk University St. Anne's University Hospital Brno, Czech Republic

Country where clinical trial is conducted

Czechia, 

Outcome

Type Measure Description Time frame Safety issue
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
Primary Magnetic resonance imaging Investigator will record high resolution structural T1-weighted (MPRAGE) images, functional T2* weighted multiband EPI sequences. The total time spent in the scanner will be approximately 40 in every session. Change from baseline immediately after completion of stimulation protocol
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