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

• Sponsor: University of Tehran (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05613790
• Collaborator: (none)
• Enrollment: 24
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 3.9
• Patients Per Site Per Month: 6.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy Volunteers	Device: Active High-Definition Transcranial Direct Current Stimulation (HD-tDCS); Device: Sham High-Definition Transcranial Direct Current Stimulation (HD-tDCS)	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 24 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Participants are allocated to one of two conditions: Active or Sham.Participants are allocated to one of two conditions: Active or Sham.
• Masking: Triple (Participant, Care Provider, Outcomes Assessor)
• Masking Description: Triple-blind study
• Primary Purpose: Treatment
• Official Title: Effect of High-Definition Transcranial Direct Current Stimulation (HD-tDCS) on Attentional Control: an fMRI Study on Healthy Participants
• Actual Study Start Date: Nov 2, 2022
• Anticipated Primary Completion Date: Mar 1, 2023
• Anticipated Study Completion Date: Mar 1, 2023

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Change in Attention Network Test (ANT) performance before and after the intervention (active versus sham HD-tDCS) [Immediate before and immediate after intervention]

2. Change in resting state functional connectivity before and after the intervention (active versus sham HD-tDCS) [Immediate before and immediate after intervention]

3. 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]

4. 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

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 39 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Faculty of Psychology	Tehran		Iran, Islamic Republic of	1445983861

Sponsors and Collaborators

• University of Tehran

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Afra Souki, Principal Investigator, University of Tehran
• ClinicalTrials.gov Identifier: NCT05613790
• Other Study ID Numbers: 511098020
• First Posted: Nov 14, 2022
• Last Update Posted: Nov 18, 2022
• Last Verified: Nov 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Afra Souki, Principal Investigator, University of Tehran: High-Definition Transcranial Direct Current Stimulation; HD-tDCS; functional Magnetic Resonance Imaging; Attentional control; Attention Network Test

Study Results

No Results Posted as of Nov 18, 2022