Effect of High-Definition Transcranial Direct Current Stimulation (HD-tDCS) on Attentional Control: an fMRI Study on Healthy Participants

In a randomized, triple-blind, sham-controlled clinical trial, we will assess the effect of a single session frontal cortex High-Definition transcranial Direct Current Stimulation (HD-tDCS) on brain activity and functional connectivity underlying the behavioral change in attentional control in healthy participants. Participants will be recruited after meeting the inclusion criteria and will be randomly assigned to active or sham stimulation groups. All participants will undergo resting-state functional Magnetic Resonance Imaging (rsfMRI) scan and perform an Attention Network Test (ANT) in a functional Magnetic Resonance Imaging (fMRI) scanner before and after receiving a single session of active or sham HD-tDCS.

Study Overview

• Status: Recruiting
• Conditions: Healthy Volunteers
• Intervention / Treatment: Device: Active High-Definition Transcranial Direct Current Stimulation (HD-tDCS); Device: Sham High-Definition Transcranial Direct Current Stimulation (HD-tDCS)

• Study Type: Interventional
• Enrollment (Anticipated): 24
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Faculty of Psychology; Phone Number: +982188259378; Email: psyedu@ut.ac.ir

Study Locations

• Iran, Islamic Republic of
  • Tehran, Iran, Islamic Republic of, 1445983861
    • Recruiting
    • Faculty of Psychology
    • Contact: Faculty of Psychology; Phone Number: +982188259378; Email: psyedu@ut.ac.ir

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 35 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Right-handed healthy adults
• Age range 20-39 years
• Normal or corrected-to-normal vision
• Willing and capable of following study protocol requirements given in the informed consent

Exclusion Criteria:

• Psychiatric conditions (e.g., depression and generalized anxiety disorder, etc.)
• Medical illness or neurological disorder (e.g., cardiovascular illness, anemia, respiratory illness, neurological illness, seizure, etc.)
• Current abuse of drugs or alcohol
• Any conditions that prevent undergoing an fMRI scan or tDCS stimulation according to the fMRI and tDCS safety checklists

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Active HD-tDCS; Participants in the active arm will receive 20 min of real High-Definition transcranial direct current stimulation. Additional ramp-up and ramp-down phases at the beginning and the end of stimulation will last for 30 s.	Device: Active High-Definition Transcranial Direct Current Stimulation (HD-tDCS); Portable multi-channel tES stimulation (Starstim 8, Neuroelectric, Barcelona, Spain) will be used.
Experimental: Sham HD-tDCS; During the sham session, the montage will be identical, however, the current amplitude will ramp up for 30 seconds, and for the remaining stimulation time, the current flow will terminate and will be kept to zero. Ramp-down phase at the end of stimulation will last for 30 s.	Device: Sham High-Definition Transcranial Direct Current Stimulation (HD-tDCS); Portable multi-channel tES stimulation (Starstim 8, Neuroelectric, Barcelona, Spain) will be used.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in Attention Network Test (ANT) performance before and after the intervention (active versus sham HD-tDCS)	Immediate before and immediate after intervention
Change in resting state functional connectivity before and after the intervention (active versus sham HD-tDCS)	Immediate before and immediate after intervention
Change in task-based functional connectivity during Attention Network Test (ANT) before and after the intervention (active versus sham HD-tDCS)	Immediate before and immediate after intervention
Change in the blood-oxygen-level-dependent (BOLD) signal during Attention Network Test (ANT) before and after the intervention (active versus sham HD-tDCS)	Immediate before and immediate after intervention

Secondary Outcome Measures

Outcome Measure	Time Frame
Side effect checklist for transcranial Direct Current Stimulation (Reported as Yes or No)	One day after simulation session

Collaborators and Investigators

• Sponsor: University of Tehran

Study record dates

Study Major Dates

• Study Start (Actual): November 2, 2022
• Primary Completion (Anticipated): March 1, 2023
• Study Completion (Anticipated): March 1, 2023

Study Registration Dates

• First Submitted: October 31, 2022
• First Submitted That Met QC Criteria: November 4, 2022
• First Posted (Actual): November 14, 2022

Study Record Updates

• Last Update Posted (Actual): November 18, 2022
• Last Update Submitted That Met QC Criteria: November 14, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: functional Magnetic Resonance Imaging; HD-tDCS; Attention Network Test; High-Definition Transcranial Direct Current Stimulation; Attentional control
• Other Study ID Numbers: 511098020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No