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

Healthy Volunteers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05613790
• Other study ID #: 511098020
• Status: Recruiting
• Phase: N/A
• Start date: November 2, 2022
• Est. completion date: March 2023

Study information

• Verified date: November 2022
• Source: University of Tehran
• Contact: Faculty of Psychology
• Phone: +982188259378
• Email: psyedu[@]ut.ac.ir
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 24
• Est. completion date: March 2023
• Est. primary completion date: March 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 39 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

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

Locations

Country	Name	City	State
Iran, Islamic Republic of	Faculty of Psychology	Tehran

Sponsors (1)

Lead Sponsor	Collaborator
University of Tehran

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Attention Network Test (ANT) performance before and after the intervention (active versus sham HD-tDCS)		Immediate before and immediate after intervention
Primary	Change in resting state functional connectivity before and after the intervention (active versus sham HD-tDCS)		Immediate before and immediate after intervention
Primary	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
Primary	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	Side effect checklist for transcranial Direct Current Stimulation (Reported as Yes or No)		One day after simulation session