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

Not Applicable

Recruiting

• Conditions: Healthy Volunteers
• Interventions: Device: Active High-Definition Transcranial Direct Current Stimulation (HD-tDCS); Device: Sham High-Definition Transcranial Direct Current Stimulation (HD-tDCS)

• Registration Number: NCT05613790
• Lead Sponsor: University of Tehran

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-10-31
• Status Verified: 2022-11
• Study Start: 2022-11-02
• Study First Submitted QC: 2022-11-04
• Study First Posted: 2022-11-14
• Last Update Submitted: 2022-11-14
• Last Update Posted: 2022-11-18
• Primary Completion: 2023-03
• Study Completion: 2023-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 24

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active HD-tDCS	Active High-Definition Transcranial Direct Current Stimulation (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.
Sham HD-tDCS	Sham High-Definition Transcranial Direct Current Stimulation (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.

Primary Outcome Measures

Name	Time	Method
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 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
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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Faculty of Psychology; 🇮🇷 Tehran, Iran, Islamic Republic of