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

NCT05613790 — Not applicable, Unknown, 24 participants, University of Tehran

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Registry	NCT05613790
Status	Unknown
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: triple, treatment
Enrollment	24 (Estimated)
Sponsor	University of Tehran (Other)
Conditions	Healthy Volunteers
Interventions	Active High-Definition Transcranial Direct Current Stimulation (HD-tDCS), Sham High-Definition Transcranial Direct Current Stimulation (HD-tDCS) (Device)
Dates	start 2022-11-02, primary completion 2023-03-01 (estimated), completion 2023-03-01 (estimated), first posted 2022-11-14, last updated 2022-11-18
Locations	1 site in Iran

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
Active HD-tDCS	Experimental	Device: 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	Experimental	Device: 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.

Active High-Definition Transcranial Direct Current Stimulation (HD-tDCS) (Device): Portable multi-channel tES stimulation (Starstim 8, Neuroelectric, Barcelona, Spain) will be used.
Sham High-Definition Transcranial Direct Current Stimulation (HD-tDCS) (Device): Portable multi-channel tES stimulation (Starstim 8, Neuroelectric, Barcelona, Spain) will be used.

+Outcome measures

Primary outcomes

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 outcomes

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

+Eligibility

Sex: All, ages: 20 Years to 39 Years, accepts healthy volunteers

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

+Locations (1)

Facility	City	Country	Status
Faculty of Psychology	Tehran	Iran	Recruiting