Non-Invasive Brain Stimulation

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04318522
• Other study ID #: 2017.331
• Status: Recruiting
• Phase: N/A
• Start date: June 28, 2019
• Est. completion date: December 2020

Study information

• Verified date: March 2020
• Source: Chinese University of Hong Kong
• Contact: Raymond Tong, PhD
• Phone: +852 3943 8454
• Email: kytong[@]cuhk.edu.hk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 2020
• Est. primary completion date: July 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Stroke

Intervention

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.

Locations

Country	Name	City	State
Hong Kong	Department of Biomedical Engineering, The Chinese University of Hong Kong	Shatin

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reaction Time (RT)	Reaction time of the subject during a cognitive task would be a measure to assess changes in performance due to stimulation	1 hour
Primary	Concentration Rate	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
Primary	Event related potential latency and amplitude	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
Primary	Functional Magnetic Resonance Imaging (fMRI)	Changes in fMRI connectivity	1 hour