NCT04318522

Brief 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.

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
40

participants targeted

Target at P25-P50 for not_applicable stroke

Timeline
Completed

Started Jun 2019

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

Study Start

First participant enrolled

June 28, 2019

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

March 17, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 24, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2020

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

March 24, 2020

Status Verified

March 1, 2020

Enrollment Period

1 year

First QC Date

March 17, 2020

Last Update Submit

March 21, 2020

Conditions

Stroke

Outcome Measures

Primary Outcomes (4)

  • 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

  • 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

  • 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

  • Functional Magnetic Resonance Imaging (fMRI)

    Changes in fMRI connectivity

    1 hour

Study Arms (2)

Stimulation Group

EXPERIMENTAL
Device: Transcranial Direct Current Stimulator

Control Group

SHAM COMPARATOR
Device: Transcranial Direct Current Stimulator

Interventions

Transcranial Direct Current StimulatorDEVICE

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.

Control GroupStimulation Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Right Handedness,
  • Age \> 18

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Biomedical Engineering, The Chinese University of Hong Kong

Shatin, Hong Kong

RECRUITING

Related Publications (2)

  • Khan A, Chen C, Eden CH, Yuan K, Tse CY, Lou W, Tong KY. Impact of anodal high-definition transcranial direct current stimulation of medial prefrontal cortex on stroop task performance and its electrophysiological correlates. A pilot study. Neurosci Res. 2022 Aug;181:46-54. doi: 10.1016/j.neures.2022.03.006. Epub 2022 Apr 1.

    PMID: 35378119DERIVED

  • Khan A, Wang X, Ti CHE, Tse CY, Tong KY. Anodal Transcranial Direct Current Stimulation of Anterior Cingulate Cortex Modulates Subcortical Brain Regions Resulting in Cognitive Enhancement. Front Hum Neurosci. 2020 Dec 16;14:584136. doi: 10.3389/fnhum.2020.584136. eCollection 2020.

    PMID: 33390917DERIVED

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Raymond Tong, PhD

    Department of Biomedical Engineering, CUHK

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Raymond Tong, PhD

CONTACT

+852 3943 8454kytong@cuhk.edu.hk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chairman and Professor

Study Record Dates

First Submitted

March 17, 2020

First Posted

March 24, 2020

Study Start

June 28, 2019

Primary Completion

July 1, 2020

Study Completion

December 1, 2020

Last Updated

March 24, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Locations

HK(1)