NCT04134195

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 18, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 22, 2019

Completed
4 months until next milestone

Study Start

First participant enrolled

February 19, 2020

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2020

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2020

Completed
Last Updated

February 24, 2021

Status Verified

September 1, 2020

Enrollment Period

1 month

First QC Date

October 18, 2019

Last Update Submit

February 23, 2021

Conditions

Healthy AgingCognitive ChangeCognitive Decline

Keywords

Transcranial direct current stimulationHealthy seniorsHealthy adults

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Study Arms (2)

Real transcranial direct current stimulation

EXPERIMENTAL

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

Device: Transcranial direct current stimulation

Sham transcranial direct current stimulation

EXPERIMENTAL

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

Device: Transcranial direct current stimulation

Interventions

Transcranial direct current stimulationDEVICE

2mA stimulation for 20 minutes

Real transcranial direct current stimulationSham transcranial direct current stimulation

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • right handed, healthy volunteers in two groups - healthy adults under 40 years, healthy seniors over 50 years

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ceitec, Masaryk University

Brno, 61300, Czechia

Location

MeSH Terms

Conditions

Cognitive Dysfunction

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsConvulsive TherapyPsychiatric Somatic TherapiesBehavioral Disciplines and ActivitiesElectroshockPsychological Techniques

Study Officials

  • Ľubomira Nováková

    Ceitec, Masaryk University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 18, 2019

First Posted

October 22, 2019

Study Start

February 19, 2020

Primary Completion

March 30, 2020

Study Completion

December 30, 2020

Last Updated

February 24, 2021

Record last verified: 2020-09

Locations

CZ(1)