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The Effect of Transcranial Direct Current Stimulation on Visual Attention - Single Sessions

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ClinicalTrials.gov Identifier: NCT04134195
Recruitment Status : Active, not recruiting
First Posted : October 22, 2019
Last Update Posted : February 20, 2020
Sponsor:
Collaborator:
St. Anne's University Hospital Brno, Czech Republic
Information provided by (Responsible Party):
Masaryk University

Brief 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.

Condition or disease Intervention/treatment Phase
Healthy Aging Cognitive Change Cognitive Decline Device: Transcranial direct current stimulation Not Applicable

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: The Effect of Transcranial Direct Current Stimulation on Visual Attention - a Combined MRI and Non-invasive Brain Stimulation Single Session Study
Actual Study Start Date : February 19, 2020
Estimated Primary Completion Date : March 30, 2020
Estimated Study Completion Date : March 30, 2020

Arm Intervention/treatment
Experimental: Real transcranial direct current stimulation
Healthy adults and healthy seniors will undergo application of real transcranial direct current stimulation over two distinct brain areas.
Device: Transcranial direct current stimulation
2mA stimulation for 20 minutes

Experimental: Sham transcranial direct current stimulation
Healthy adults and healthy seniors will undergo application of sham transcranial direct current stimulation over two distinct brain areas.
Device: Transcranial direct current stimulation
2mA stimulation for 20 minutes




Primary Outcome Measures :
  1. Visual-attention task accuracy [ Time Frame: Change from baseline immediately after completion of stimulation protocol ]
    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).

  2. Magnetic resonance imaging [ Time Frame: Change from baseline immediately after completion of stimulation protocol ]
    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.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04134195


Locations
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Czechia
Ceitec, Masaryk University
Brno, Czechia, 61300
Sponsors and Collaborators
Masaryk University
St. Anne's University Hospital Brno, Czech Republic
Investigators
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Principal Investigator: Ľubomira Nováková Ceitec, Masaryk University
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Responsible Party: Masaryk University
ClinicalTrials.gov Identifier: NCT04134195    
Other Study ID Numbers: NV18-04-00256-single
First Posted: October 22, 2019    Key Record Dates
Last Update Posted: February 20, 2020
Last Verified: February 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Masaryk University:
Transcranial direct current stimulation
Healthy seniors
Healthy adults
Additional relevant MeSH terms:
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Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Mental Disorders