Healthy VolunteersNCT05613790
Effect of High-Definition Transcranial Direct Current Stimulation (HD-tDCS) on Attentional Control: an fMRI Study on Healthy Participants
A study testing Active High-Definition Transcranial Direct Current Stimulation (HD-tDCS) in people with Healthy Volunteers, run by University of Tehran at 1 site in Iran.
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. Read more about this study
- Who is it for?
- Ages 20 to 39 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Active High-Definition Transcranial Direct Current Stimulation (HD-tDCS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteIran
- Study dates
- 2 Nov 2022to Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 39 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Iran1 site, 1 recruiting
- Recruiting
Faculty of Psychology
Tehran, 1445983861
Faculty of Psychology, +982188259378, psyedu@ut.ac.ir
About this study
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.
- Conditions
- Healthy Volunteers
- Being tested
- Active High-Definition Transcranial Direct Current Stimulation (HD-tDCS), Sham High-Definition Transcranial Direct Current Stimulation (HD-tDCS)
- Keywords
- High-Definition Transcranial Direct Current Stimulation, HD-tDCS, functional Magnetic Resonance Imaging, Attentional control, Attention Network Test
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Active HD-tDCS | Experimental | 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. Receives: Device: Active High-Definition Transcranial Direct Current Stimulation (HD-tDCS) |
| Sham HD-tDCS | Experimental | 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. Receives: Device: Sham High-Definition Transcranial Direct Current Stimulation (HD-tDCS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Attention Network Test (ANT) performance before and after the intervention (active versus sham HD-tDCS)
Measured: Immediate before and immediate after intervention
Change in resting state functional connectivity before and after the intervention (active versus sham HD-tDCS)
Measured: 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)
Measured: 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)
Measured: Immediate before and immediate after intervention
Secondary outcomes (1)
Side effect checklist for transcranial Direct Current Stimulation (Reported as Yes or No)
Measured: One day after simulation session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2022
- Study start2 Nov 2022
- Primary completionMar 2023 (estimated)
- Study completionMar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are allocated to one of two conditions: Active or Sham.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Tehran
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Afra Souki, University of Tehran
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05613790
- Sponsor's protocol ID
- 511098020
- Status last verified
- Nov 2022
- First submitted
- 31 Oct 2022
- Last updated
- 18 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of High-Definition Transcranial Direct Current Stimulation (HD-tDCS) on Attentional Control: an fMRI Study on Healthy Participants
- ClinicalTrials.gov ID
- NCT05613790
- Acronym / sponsor ID
- 511098020
- Conditions
- Healthy Volunteers
- Keywords
- High-Definition Transcranial Direct Current Stimulation, HD-tDCS, functional Magnetic Resonance Imaging, Attentional control, Attention Network Test
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- University of TehranUniversity, hospital or other
- Study start
- 2 Nov 2022 (actual)
- Primary completion
- Mar 2023 (estimated)
- Study completion
- Mar 2023 (estimated)
- First posted
- 14 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants are allocated to one of two conditions: Active or Sham.
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 20 to 39 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active High-Definition Transcranial Direct Current Stimulation (HD-tDCS)Portable multi-channel tES stimulation (Starstim 8, Neuroelectric, Barcelona, Spain) will be used. | Device | Active HD-tDCS |
| Sham High-Definition Transcranial Direct Current Stimulation (HD-tDCS)Portable multi-channel tES stimulation (Starstim 8, Neuroelectric, Barcelona, Spain) will be used. | Device | Sham HD-tDCS |
Primary outcome
Change in Attention Network Test (ANT) performance before and after the intervention (active versus sham HD-tDCS)
Time frame: Immediate before and immediate after intervention
Change in resting state functional connectivity before and after the intervention (active versus sham HD-tDCS)
Time frame: 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)
Time frame: 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)
Time frame: Immediate before and immediate after intervention
1 secondary outcome
Side effect checklist for transcranial Direct Current Stimulation (Reported as Yes or No)
Time frame: One day after simulation session
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2022.
- Individual participant dataSharing planned: No
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Healthy Participants
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active High-Definition Transcranial Direct Current Stimulation (HD-tDCS) in people with Healthy Volunteers, run by University of Tehran at 1 site in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Faculty of Psychology (+982188259378, psyedu@ut.ac.ir), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Attention Network Test (ANT) performance before and after the intervention (active versus sham HD-tDCS) (time frame: Immediate before and immediate after intervention). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2022.