HealthyNCT03712150
Effects of Gene Polymorphism After Transcranial Cranial Direct Current Stimulation on the Corticobulbar Excitability
An observational study of Healthy, run by The Catholic University of Korea at 2 sites in South Korea.
Trial summary
This study aims to examine the effects of transcranial direct current stimulation at corticobulbar excitability in individuals with different gene polymorphism. Read more about this study
- Who is it for?
- Ages 19 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- tdcs
- Type of treatment
- Medical device
- How many people
- 20 participants
- Where
- 2 sitesSouth Korea
- Study dates
- 10 Nov 2018to 8 Aug 2019
- Phase
- Observational
- 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 19 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Healthy young volunteers
Who may be able to join
- Age 19-40 years
- Informed consent
Who cannot join
- History of epilepsy
- Presence of cardiac pacemaker
- previous brain surgery
- previous swallowing problems
- current use of medication which acts on the central nervous system
- presence of implanted metal intracranially
Trial locations and contacts
2 sites in 1 country.
South Korea2 sites
Department of Rehabilitation Medicine
Bucheon-si, Bucheonshi
Department of Rehabilitation Medicine Bucheon St Mary's Hospital, Catholic University of Korea, College of Medicine
Bucheon-si, Kyounggido
About this study
Official title: Role of Genetic Polymorphism in Neuroplasticity Involved in Dysphagia Recovery- Part 2
This study aims to examine the effects of transcranial direct current stimulation at corticobulbar excitability in individuals with different gene polymorphism.
Read the detailed description
The effects of TDCS on corticobulbar excitability of the brain after inhibitory pre-conditioning will be compared in patients with different BDNF phenotypes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tdcsDevice
application of optimised parameters of tDCS (anodal stimulation, 1.5 mA, 10 min) over the unconditioned hemisphere reverses the brain and behavioural consequences of inhibitory pre-conditioning
| Study group | Role | What they receive |
|---|---|---|
| Healthy | Healthy adults
- Participants will receive single session of tdcs after application Receives: Device: tdcs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brain corticobulbar excitability
Change of Brain corticobulbar excitability by motor evoked potentials
Measured: Immediately after single conditioning the brain
Secondary outcomes (2)
Tongue pressure measurement-
Change of tongue pressure measurement by Intra oral pressure assessment
Measured: Immediate after single conditioning the brain
Electrophysiological responses of swallowing -
Change of Electrophysiological responses of swallowing - With the use of a laryngeal transducer, will measure the mylohyoid amplitude
Measured: Immediate after single conditioning the brain
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2018
- Study start10 Nov 2018
- Primary completion8 Jun 2019
- Study completion8 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Catholic University of Korea
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sun Im, The Catholic University of Korea
- Investigators
- Sun Im, MD PhD, Principal investigator, The Catholic University of Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03712150
- Sponsor's protocol ID
- HC18TNSV0061
- Status last verified
- Nov 2019
- First submitted
- 10 Oct 2018
- Last updated
- 7 Nov 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Genetic Polymorphism in Neuroplasticity Involved in Dysphagia Recovery- Part 2
- ClinicalTrials.gov ID
- NCT03712150
- Acronym / sponsor ID
- HC18TNSV0061
- Conditions
- Healthy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- The Catholic University of KoreaUniversity, hospital or other
- Study start
- 10 Nov 2018 (actual)
- Primary completion
- 8 Jun 2019 (actual)
- Study completion
- 8 Aug 2019 (actual)
- First posted
- 19 Oct 2018 (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.
This study aims to examine the effects of transcranial direct current stimulation at corticobulbar excitability in individuals with different gene polymorphism.
Detailed description
The effects of TDCS on corticobulbar excitability of the brain after inhibitory pre-conditioning will be compared in patients with different BDNF phenotypes
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy | – | Device: tdcsHealthy adults - Participants will receive single session of tdcs after application |
Who may qualify
- Ages
- 19 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Healthy young volunteers
Key inclusion criteria (2 listed)
- Age 19-40 years
- Informed consent
Key exclusion criteria (6 listed)
- History of epilepsy
- Presence of cardiac pacemaker
- previous brain surgery
- previous swallowing problems
- current use of medication which acts on the central nervous system
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 |
|---|---|---|
| tdcsapplication of optimised parameters of tDCS (anodal stimulation, 1.5 mA, 10 min) over the unconditioned hemisphere reverses the brain and behavioural consequences of inhibitory pre-conditioning | Device | Healthy |
Primary outcome
Brain corticobulbar excitability
Time frame: Immediately after single conditioning the brain
Change of Brain corticobulbar excitability by motor evoked potentials
2 secondary outcomes
Tongue pressure measurement-
Time frame: Immediate after single conditioning the brain
Electrophysiological responses of swallowing -
Time frame: Immediate after single conditioning the brain
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2019.
- Individual participant dataSharing planned: No
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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.
Sun Im, MD PhD principal investigator
The Catholic University of Korea
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy, run by The Catholic University of Korea at 2 sites in South Korea.
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 6 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: finished, as of the sponsor's last update on 7 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in South Korea. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brain corticobulbar excitability (time frame: Immediately after single conditioning the brain). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Nov 2019.