- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04134195
The Effect of Transcranial Direct Current Stimulation on Visual Attention - Single Sessions
February 23, 2021 updated by: Masaryk University
The Effect of Transcranial Direct Current Stimulation on Visual Attention - a Combined MRI and Non-invasive Brain Stimulation Single Session Study
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
50
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Brno, Czechia, 61300
- Ceitec, Masaryk University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: SUPPORTIVE_CARE
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / 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.
|
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.
|
2mA stimulation for 20 minutes
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
|
Change from baseline immediately after completion of stimulation protocol
|
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.
|
Change from baseline immediately after completion of stimulation protocol
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Ľubomira Nováková, Ceitec, Masaryk University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
February 19, 2020
Primary Completion (ACTUAL)
March 30, 2020
Study Completion (ACTUAL)
December 30, 2020
Study Registration Dates
First Submitted
October 18, 2019
First Submitted That Met QC Criteria
October 18, 2019
First Posted (ACTUAL)
October 22, 2019
Study Record Updates
Last Update Posted (ACTUAL)
February 24, 2021
Last Update Submitted That Met QC Criteria
February 23, 2021
Last Verified
September 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NV18-04-00256-single
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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