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

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: 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

• Study Type: Observational
• Enrollment (Actual): 20

Contacts and Locations

Study Locations

• Korea, Republic of
  • Bucheonshi
    • Bucheon, Bucheonshi, Korea, Republic of
      • Department of Rehabilitation Medicine
  • Kyounggido
    • Bucheon, Kyounggido, Korea, Republic of
      • Department of Rehabilitation Medicine Bucheon St Mary's Hospital, Catholic University of Korea, College of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Healthy young volunteers

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Brain corticobulbar excitability	Change of Brain corticobulbar excitability by motor evoked potentials	Immediately after single conditioning the brain

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tongue pressure measurement-	Change of tongue pressure measurement by Intra oral pressure assessment	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	Immediate after single conditioning the brain

Collaborators and Investigators

• Sponsor: The Catholic University of Korea
• Investigators: Principal Investigator: Sun Im, MD PhD, The Catholic University of Korea

Study record dates

Study Major Dates

• Study Start (Actual): November 10, 2018
• Primary Completion (Actual): June 8, 2019
• Study Completion (Actual): August 8, 2019

Study Registration Dates

• First Submitted: October 10, 2018
• First Submitted That Met QC Criteria: October 17, 2018
• First Posted (Actual): October 19, 2018

Study Record Updates

• Last Update Posted (Actual): November 7, 2019
• Last Update Submitted That Met QC Criteria: November 5, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: HC18TNSV0061

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No