NCT05613790

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
24

participants targeted

Target at P25-P50 for not_applicable healthy-volunteers

Timeline
Completed

Started Nov 2022

Shorter than P25 for not_applicable healthy-volunteers

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 31, 2022

Completed
2 days until next milestone

Study Start

First participant enrolled

November 2, 2022

Completed
12 days until next milestone

First Posted

Study publicly available on registry

November 14, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2023

Completed
Last Updated

November 18, 2022

Status Verified

November 1, 2022

Enrollment Period

4 months

First QC Date

October 31, 2022

Last Update Submit

November 14, 2022

Conditions

Healthy Volunteers

Keywords

High-Definition Transcranial Direct Current StimulationHD-tDCSfunctional Magnetic Resonance ImagingAttentional controlAttention Network Test

Outcome Measures

Primary Outcomes (4)

  • 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 (1)

  • Side effect checklist for transcranial Direct Current Stimulation (Reported as Yes or No)

    One day after simulation session

Study Arms (2)

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.

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.

Device: Sham High-Definition Transcranial Direct Current Stimulation (HD-tDCS)

Interventions

Active High-Definition Transcranial Direct Current Stimulation (HD-tDCS)DEVICE

Portable multi-channel tES stimulation (Starstim 8, Neuroelectric, Barcelona, Spain) will be used.

Active HD-tDCS
Sham High-Definition Transcranial Direct Current Stimulation (HD-tDCS)DEVICE

Portable multi-channel tES stimulation (Starstim 8, Neuroelectric, Barcelona, Spain) will be used.

Sham HD-tDCS

Eligibility Criteria

Age20 Years - 39 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Psychology

Tehran, 1445983861, Iran

RECRUITING

Central Study Contacts

Faculty of Psychology

CONTACT

+982188259378psyedu@ut.ac.ir

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Masking Details
Triple-blind study
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants are allocated to one of two conditions: Active or Sham.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 31, 2022

First Posted

November 14, 2022

Study Start

November 2, 2022

Primary Completion

March 1, 2023

Study Completion

March 1, 2023

Last Updated

November 18, 2022

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will not share

Locations

IR(1)