Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Effects of Gene Polymorphism After Transcranial Cranial Direct Current Stimulation on the Corticobulbar Excitability

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03712150
Recruitment Status : Recruiting
First Posted : October 19, 2018
Last Update Posted : January 4, 2019
Sponsor:
Information provided by (Responsible Party):
Sun Im, The Catholic University of Korea

Brief Summary:
This study aims to examine the effects of transcranial direct current stimulation at corticobulbar excitability in individuals with different gene polymorphism.

Condition or disease Intervention/treatment
Healthy Device: tdcs

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

Layout table for study information
Study Type : Observational
Estimated Enrollment : 42 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Role of Genetic Polymorphism in Neuroplasticity Involved in Dysphagia Recovery- Part 2
Actual Study Start Date : November 10, 2018
Estimated Primary Completion Date : February 28, 2020
Estimated Study Completion Date : June 1, 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Healthy

Healthy adults

- Participants will receive single session of tdcs after application

Device: tdcs
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




Primary Outcome Measures :
  1. Brain corticobulbar excitability [ Time Frame: Immediately after single conditioning the brain ]
    Change of Brain corticobulbar excitability by motor evoked potentials


Secondary Outcome Measures :
  1. Tongue pressure measurement- [ Time Frame: Immediate after single conditioning the brain ]
    Change of tongue pressure measurement by Intra oral pressure assessment

  2. Electrophysiological responses of swallowing - [ Time Frame: Immediate after single conditioning the brain ]
    Change of Electrophysiological responses of swallowing - With the use of a laryngeal transducer, will measure the mylohyoid amplitude


Biospecimen Retention:   Samples With DNA
DNA of gene polymorphism from the Polymorphisms in brain-derived neurotrophic factor


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   19 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Healthy young volunteers
Criteria

Inclusion Criteria:

  • Age 19-40 years
  • Informed consent

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03712150


Contacts
Layout table for location contacts
Contact: Sun Im, MD PhD 032-340- ext 2170 lafolia@catholic.ac.kr
Contact: Geun Young Park, MD PhD 032-340- ext 7004

Locations
Layout table for location information
Korea, Republic of
Department of Rehabilitation Medicine Recruiting
Bucheon, Bucheonshi, Korea, Republic of
Department of Rehabilitation Medicine Bucheon St Mary's Hospital, Catholic University of Korea, College of Medicine Recruiting
Bucheon, Kyounggido, Korea, Republic of
Contact: Sun Im, MD, PhD    82-32-340-7392    lafolia@catholic.ac.kr   
Sub-Investigator: Geun-Young Park, MD, PhD         
Sponsors and Collaborators
The Catholic University of Korea
Investigators
Layout table for investigator information
Principal Investigator: Sun Im, MD PhD The Catholic University of Korea

Layout table for additonal information
Responsible Party: Sun Im, Sun Im, Assistant Professor, The Catholic University of Korea, The Catholic University of Korea
ClinicalTrials.gov Identifier: NCT03712150     History of Changes
Other Study ID Numbers: HC18TNSV0061
First Posted: October 19, 2018    Key Record Dates
Last Update Posted: January 4, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No