Non-Invasive Brain Stimulation

March 21, 2020 updated by: Raymond KY Tong, Chinese University of Hong Kong

Effect of Conventional Transcranial Direct Current Stimulation (c-tDCS) and High-definition Transcranial Direct Current Stimulation (HD-tDCS) on the Prefrontal Cortex

The study focusses on utilizing neuroimaging modalities, including Electroencephalography (EEG) and Functional Magnetic Resonance Imaging (fMRI) to study the impact of non-invasive brain stimulation on the prefrontal cortex during a cognitive task.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

In this study, a total of 40 subjects will be randomly assigned to 2 groups i.e. experimental and sham. Conventional transcranial direct current stimulation (c-tDCS) and high-definition transcranial direct current stimulation (HD-tDCS) will be used to stimulate the prefrontal cortex of the brain. EEG and fMRI will be collected before, during and after stimulation to understand the impact of stimulation on brain dynamics. The investigators hypothesize that the stimulation of the prefrontal cortex will improve performance during cognitive tasks along with changes in the neural processing detected by neuroimaging modalities.

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hong Kong
      • Shatin, Hong Kong
        • Recruiting
        • Department of Biomedical Engineering, The Chinese University of Hong Kong

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Right Handedness,
  • Age > 18

Exclusion Criteria:

  • History of any other neurological disease,
  • Any psychological or psychiatric disease,
  • Significant visual or auditory impairments,
  • tDCS contraindications including implanted metallic or electronic devices, seizures or convulsions, and pregnancy.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Stimulation Group
Device: Transcranial Direct Current Stimulator
Transcranial Direct Current Stimulation (tDCS) is a non-invasive brain stimulation device that can excite or inhibit the brain activity depending on the stimulation protocol. It has mainly two variants including conventional c-tDCS and High-Definition HD-tDCS.
SHAM_COMPARATOR: Control Group
Device: Transcranial Direct Current Stimulator
Transcranial Direct Current Stimulation (tDCS) is a non-invasive brain stimulation device that can excite or inhibit the brain activity depending on the stimulation protocol. It has mainly two variants including conventional c-tDCS and High-Definition HD-tDCS.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reaction Time (RT)
Time Frame: 1 hour
Reaction time of the subject during a cognitive task would be a measure to assess changes in performance due to stimulation
1 hour
Concentration Rate
Time Frame: 1 hour
The percentage of accurate responses during the cognitive task within the stipulated time will be calculated to see an impact on concentration after stimulation
1 hour
Event related potential latency and amplitude
Time Frame: 1 hour
Changes in latency and amplitude of event related potentials including P300 & N200 would be used as neural marker to understand cognitive processing in the brain.
1 hour
Functional Magnetic Resonance Imaging (fMRI)
Time Frame: 1 hour
Changes in fMRI connectivity
1 hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chinese University of Hong Kong

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

June 28, 2019

Primary Completion (ANTICIPATED)

July 1, 2020

Study Completion (ANTICIPATED)

December 1, 2020

Study Registration Dates

First Submitted

March 17, 2020

First Submitted That Met QC Criteria

March 21, 2020

First Posted (ACTUAL)

March 24, 2020

Study Record Updates

Last Update Posted (ACTUAL)

March 24, 2020

Last Update Submitted That Met QC Criteria

March 21, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • 2017.331

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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