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

Primary Purpose

Healthy Aging, Cognitive Change, Cognitive Decline

Status
Completed
Phase
Not Applicable
Locations
Czechia
Study Type
Interventional
Intervention
Transcranial direct current stimulation
Sponsored by
Masaryk University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Healthy Aging focused on measuring Transcranial direct current stimulation, Healthy seniors, Healthy adults

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Ceitec, Masaryk University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Real transcranial direct current stimulation

Sham transcranial direct current stimulation

Arm Description

Healthy adults and healthy seniors will undergo application of real transcranial direct current stimulation over two distinct brain areas.

Healthy adults and healthy seniors will undergo application of sham transcranial direct current stimulation over two distinct brain areas.

Outcomes

Primary Outcome Measures

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).
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.

Secondary Outcome Measures

Full Information

First Posted
October 18, 2019
Last Updated
February 23, 2021
Sponsor
Masaryk University
Collaborators
St. Anne's University Hospital Brno, Czech Republic
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1. Study Identification

Unique Protocol Identification Number
NCT04134195
Brief Title
The Effect of Transcranial Direct Current Stimulation on Visual Attention - Single Sessions
Official Title
The Effect of Transcranial Direct Current Stimulation on Visual Attention - a Combined MRI and Non-invasive Brain Stimulation Single Session Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
February 19, 2020 (Actual)
Primary Completion Date
March 30, 2020 (Actual)
Study Completion Date
December 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Masaryk University
Collaborators
St. Anne's University Hospital Brno, Czech Republic

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy Aging, Cognitive Change, Cognitive Decline
Keywords
Transcranial direct current stimulation, Healthy seniors, Healthy adults

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Real transcranial direct current stimulation
Arm Type
Experimental
Arm Description
Healthy adults and healthy seniors will undergo application of real transcranial direct current stimulation over two distinct brain areas.
Arm Title
Sham transcranial direct current stimulation
Arm Type
Experimental
Arm Description
Healthy adults and healthy seniors will undergo application of sham transcranial direct current stimulation over two distinct brain areas.
Intervention Type
Device
Intervention Name(s)
Transcranial direct current stimulation
Intervention Description
2mA stimulation for 20 minutes
Primary Outcome Measure Information:
Title
Visual-attention task accuracy
Description
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).
Time Frame
Change from baseline immediately after completion of stimulation protocol
Title
Magnetic resonance imaging
Description
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.
Time Frame
Change from baseline immediately after completion of stimulation protocol

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ľubomira Nováková
Organizational Affiliation
Ceitec, Masaryk University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ceitec, Masaryk University
City
Brno
ZIP/Postal Code
61300
Country
Czechia

12. IPD Sharing Statement

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

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