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

Sponsor

Masaryk University (Other)

Overall Status

Completed

CT.gov ID

NCT04134195

Collaborator

St. Anne's University Hospital Brno, Czech Republic (Other)

Enrollment

Location

Arms

10.3

Actual Duration (Months)

4.8

Patients Per Site Per Month

Study Details

Study Description

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	N/A

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.

Study Design

Study Type:

Interventional

Actual 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 :

Feb 19, 2020

Actual Primary Completion Date :

Mar 30, 2020

Actual Study Completion Date :

Dec 30, 2020

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Visual-attention task accuracy [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).
Magnetic resonance imaging [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ceitec, Masaryk University	Brno		Czechia	61300

Sponsors and Collaborators

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

Investigators

Principal Investigator: Ľubomira Nováková, Ceitec, Masaryk University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Masaryk University

ClinicalTrials.gov Identifier:

NCT04134195

Other Study ID Numbers:

NV18-04-00256-single

First Posted:

Oct 22, 2019

Last Update Posted:

Feb 24, 2021

Last Verified:

Sep 1, 2020

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Masaryk University

Transcranial direct current stimulation

Healthy seniors

Healthy adults

Additional relevant MeSH terms:

Cognitive Dysfunction

Study Results

No Results Posted as of Feb 24, 2021