StrokeNCT04318522
Non-Invasive Brain Stimulation
A study testing Transcranial Direct Current Stimulator in people with Stroke, run by Chinese University of Hong Kong at 1 site in Hong Kong.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stroke
- What is being tested?
- Transcranial Direct Current Stimulator
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteHong Kong
- Study dates
- 28 Jun 2019to Dec 2020
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Right Handedness,
- Age > 18
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site, 1 recruiting
- Recruiting
Department of Biomedical Engineering, The Chinese University of Hong Kong
Shatin
Raymond Tong, PhD
About this study
Official title: 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.
Read the 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.
- Conditions
- Stroke
- Being tested
- Transcranial Direct Current Stimulator
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Stimulation Group | Experimental | Not described Receives: Device: Transcranial Direct Current Stimulator |
| Control Group | Sham comparator | Not described Receives: Device: Transcranial Direct Current Stimulator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reaction Time (RT)
Reaction time of the subject during a cognitive task would be a measure to assess changes in performance due to stimulation
Measured: 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
Measured: 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.
Measured: 1 hour
Functional Magnetic Resonance Imaging (fMRI)
Changes in fMRI connectivity
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2020
- Study start28 Jun 2019
- Primary completionJul 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Raymond KY Tong, Chinese University of Hong Kong
- Investigators
- Raymond Tong, PhD, Principal investigator, Department of Biomedical Engineering, CUHK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04318522
- Sponsor's protocol ID
- 2017.331
- Status last verified
- Mar 2020
- First submitted
- 17 Mar 2020
- Last updated
- 24 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35378119Khan 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.
PubMed 33390917
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Conventional Transcranial Direct Current Stimulation (c-tDCS) and High-definition Transcranial Direct Current Stimulation (HD-tDCS) on the Prefrontal Cortex
- ClinicalTrials.gov ID
- NCT04318522
- Acronym / sponsor ID
- 2017.331
- Conditions
- Stroke
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 28 Jun 2019 (actual)
- Primary completion
- Jul 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 24 Mar 2020 (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.
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.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stimulation Group | Experimental | Device: Transcranial Direct Current Stimulator |
| Control Group | Sham comparator | Device: Transcranial Direct Current Stimulator |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Right Handedness,
- Age > 18
Key exclusion criteria (4 listed)
- 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.
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 |
|---|---|---|
| Transcranial Direct Current StimulatorTranscranial 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. | Device | Control Group, Stimulation Group |
Primary outcome
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
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
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.
Functional Magnetic Resonance Imaging (fMRI)
Time frame: 1 hour
Changes in fMRI connectivity
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2020.
- Derived from this study: PubMed 35378119Khan 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.
- Derived from this study: PubMed 33390917Khan 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.
- Individual participant dataSharing planned: No
Related trials for Stroke
Recruiting
Connectomic Alterations Following Acute Ischemic Stroke in the MCA Territory
Ischemic Stroke
RecruitingObservational study
Clevidipine for the Antihypertensive Treatment of Acute Intracerebral Hemorrhage
Intracerebral Hemorrhage, Stroke
Active, not recruitingPhase 4
A Study Testing How Well the Drug Extract of Ginkgo Biloba Leaves Tablets Works for People With Memory or Thinking Problems After a Stroke When Added to Standard Treatment
Ischemic Stroke Hospitalized, Impairment, Cognitive
Not yet recruitingPhase 4
Anti-inflammatory and Anti-thrombotic Therapy With colcHicine and Low Dose Rivaroxaban for Major Adverse Cardiovascular Events Reduction in Ischemic Stroke
Ischemic Stroke
RecruitingObservational study
CoMind Early Feasibility Study
Intracranial Pressure, Intracranial Pressure Changes
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.
Raymond Tong, PhD principal investigator
Department of Biomedical Engineering, CUHK
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial Direct Current Stimulator in people with Stroke, run by Chinese University of Hong Kong at 1 site in Hong Kong.
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 2 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 24 Mar 2020. 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 Hong Kong. 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. Some participants in this study may receive a placebo. 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 Raymond Tong, PhD (+852 3943 8454, kytong@cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reaction Time (RT) (time frame: 1 hour). 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?
On the ClinicalTrials.gov record for NCT04318522, which also lists 2 linked publications.
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 24 Mar 2020.