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Investigating brain mechanisms and new treatment modalities for persistent postural-perceptual dizziness (PPPD)

Status Approved

First Submitted Date

2020/05/27
Registered Date

2020/05/28
Last Updated Date

2020/05/28

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CRIS Required

WHO ICTRP (International Clinical Trial Registry Platform) Required

1. Background

Background - CRIS Registration Number, Unique Protocol ID, Public/Brief Title, Scientific Title, Acronym, MFDS Regulated Study, IND/IDE Protocol, Registered at Other Registry, Name of Registry/Registration Number
CRIS Registration Number	KCT0005068
Unique Protocol ID	OC18ENSI0102
Public/Brief Title	Investigating brain mechanisms and new treatment modalities for persistent postural-perceptual dizziness (PPPD)
Scientific Title	Investigating brain mechanisms and new treatment modalities for persistent postural-perceptual dizziness (PPPD)
Acronym
MFDS Regulated Study	No
IND/IDE Protocol	No
Registered at Other Registry	No
Healthcare Benefit Approval Status	Not applicable

2. Institutional Review Board / Ethics Committee

Institutional Review Board Information
Board Approval Status	Submitted approval
Board Approval Number	OC18ENSI0102
Approval Date	2018-12-24
Institutional Review Board Name	Institutional Review Board of the Incheon St. Mary's Hospital, Catholic University
Institutional Review Board Address	56, Dongsu-ro, Bupyeong-gu, Incheon
Institutional Review Board Telephone	032-280-5371
Data Monitoring Committee	No

3. Contact Details

Contact Details Information - Contact Person for Principal Investigator / Scientific Queries, Contact Person for Public Queries, Contact Person for Updating Information의 Name, Title, Email, Telephone, Cellular Phone, Affiliation, Address
Contact Person for Principal Investigator / Scientific Queries
Name	Seonghee Na
Title	Assistant Professor
Telephone	+82-32-280-5254
Affiliation	The Catholic University of Korea, Incheon St. Mary's Hospital
Address	56, Dongsu-ro, Bupyeong-gu, Incheon
Contact Person for Public Queries
Name	Jooyeon Im
Title	Research Fellow
Telephone	+82-32-280-5254
Affiliation	The Catholic University of Korea, Incheon St. Mary's Hospital
Address	56, Dongsu-ro, Bupyeong-gu, Incheon
Contact Person for Updating Information
Name	Jooyeon Im
Title	Research Fellow
Telephone	+82-32-280-5254
Affiliation	The Catholic University of Korea, Incheon St. Mary's Hospital
Address	56, Dongsu-ro, Bupyeong-gu, Incheon

4. Status

Status Information - Study Site, Overall Recruitment Status, Date of First Enrollment, Status of First Enrollment, Target Number of Participant, Primary Completion Date, Recruitment Status by Participating Study Site, Name of Study Site, Recruitment Status, Date of First Enrollment, Status of First Enrollemnt
Recruitment Status by Participating Study Site 1
Study Site	Single
Overall Recruitment Status	Recruiting
Date of First Enrollment	2019-02-15 Actual
Target Number of Participant	60
Primary Completion Date
Study Completion Date
Name of Study	The Catholic University of Korea, Incheon St. Mary's Hospital
Recruitment Status	Recruiting
Date of First Enrollment	2019-02-15 ,

5. Source of Monetary / Material Support

Source of Monetary / Material Support Information - Organization Name, Organization Type, Project ID
1. Source of Monetary/Material Support
Organization Name	National Research Foundation
Organization Type	Others
Project ID

6. Sponsor Organization

Sponsor Organization Information - Organization Name, Organization Type
1. Sponsor Organization
Organization Name	The Catholic University of Korea, Incheon St. Mary's Hospital
Organization Type	Medical Institute

7. Study Summary

Study Summary Information
Lay Summary	Persistent physical-perceptual dizziness (PPPD) is a chronic functional vestibular disorder characterized by dizziness, unsteadiness, and/or non-spinning vertigo. The aim of this study is to uncover the pathophysiological brain mechanism of PPPD and develop new treatments. The first phase of the study seeks to identify the pathophysiological brain mechanisms of PPPD by applying multi-modal neuroimaging techniques. Brain imaging techniques such as magnetic resonance imaging (MRI) and single-photon emission tomography (SPECT) are used to identify structural, functional, and biochemical abnormalities related to the disease. In this study, noninvasive neurostimulation technique transcranial direct current stimulation, or tDCS, was selected as a new treatment model for PPPD. In the second phase of the study, based on the results of the first phase of the study, tDCS treatment parameters (stimulation target, intensity, time, frequency, etc.) suitable for PPPD will be developed. In the third phase of the study, the treatment protocol developed in phase 2 is applied to PPPD patients to evaluate the therapeutic effectiveness and safety of tDCS. In addition to clinical evaluation, functional changes in the brain will be analyzed using SPECT.

Study Summary Information

Lay Summary

Persistent physical-perceptual dizziness (PPPD) is a chronic functional vestibular disorder characterized by dizziness, unsteadiness, and/or non-spinning vertigo. The aim of this study is to uncover the pathophysiological brain mechanism of PPPD and develop new treatments.

The first phase of the study seeks to identify the pathophysiological brain mechanisms of PPPD by applying multi-modal neuroimaging techniques. Brain imaging techniques such as magnetic resonance imaging (MRI) and single-photon emission tomography (SPECT) are used to identify structural, functional, and biochemical abnormalities related to the disease.

In this study, noninvasive neurostimulation technique transcranial direct current stimulation, or tDCS, was selected as a new treatment model for PPPD. In the second phase of the study, based on the results of the first phase of the study, tDCS treatment parameters (stimulation target, intensity, time, frequency, etc.) suitable for PPPD will be developed.

In the third phase of the study, the treatment protocol developed in phase 2 is applied to PPPD patients to evaluate the therapeutic effectiveness and safety of tDCS. In addition to clinical evaluation, functional changes in the brain will be analyzed using SPECT.

8. Study Design

Study Design Information - Study Type, Study Purpose, Phase, Intervention Model, Blinding/Masking, Blinded Subject, Allocation, Intervention Type, Intervention Description, Number of Arms, Arm Label, Target Number of Participant, Arm Type, Arm Description
Study Type	Interventional Study
Study Purpose	Basic Science
Phase	Not applicable
Intervention Model	Parallel
Blinding/Masking	Double
Blinded Subject	Subject, Investigator
Allocation	RCT
Intervention Type	Medical Device
Intervention Description	(1) Active tDCS group: 2mA tdcs 20 minutes daily, 5 times per week, 3 weeks, total of 15 times on the prefrontal cortex. (2) Sham tDCS group: sham tdcs 20 minutes daily, 5 times per week, 3 weeks, total of 15 times on the prefrontal cortex. (3) No intervention group: baseline visit only, no tdcs is applied.
Number of Arms	3
Arm 1	Arm Label Active tDCS
	Target Number of Participant 20
	Arm Type Experimental
	Arm Description Active tDCS group: 2mA tdcs 20 minutes daily, 5 times per week, 3 weeks, total of 15 times on the prefrontal cortex.
Arm 2	Arm Label Sham tDCS
	Target Number of Participant 20
	Arm Type Sham comparator
	Arm Description Sham tdcs 20 minutes daily, 5 times per week, 3 weeks, total of 15 times on the prefrontal cortex.
Arm 3	Arm Label Control
	Target Number of Participant 20
	Arm Type No intervention
	Arm Description Baseline visit only, no tdcs is applied.

9. Subject Eligibility

Subject Eligibility Information
Condition(s)/Problem(s)	* (H60-H95)Diseases of the ear and mastoid process (H81.8)Other disorders of vestibular function Persistent Postural-Perceptual Dizziness (PPPD)
Rare Disease	No
Inclusion Criteria	Gender Both
	Age 18Year~69Year
	Description 1. PPPD group - Men and women between the ages of 18 and 69 - Meeting the diagnostic criteria for persistent postural-perceptual dizziness (PPPD) of the Barany Society for diagnosis of dizziness 2. Control group - Men and women between the ages of 18 and 69
Exclusion Criteria	- Have major medical, neurological (excluding PPPD), or psychiatric disorders - If pregnant, breast-feeding, or have a pregnancy plan - Not suitable for MRI and SPECT imaging (in-body metal and medical devices, claustrophobia, etc.) - If there is a problem attaching tDCS electrodes due to deformity, inflammatory response, or other dermatological problems of the scalp (PPPD group only) - Loss of consciousness for more than an hour due to other causes other than general anesthesia - Has been hospitalized with a head injury
Healthy Volunteers	Yes

10. Outcome Measure(s)

Outcome Measure(s) Information - Type of Primary Outcome, Primary Outcome, Outcome, Timepoint, Secondary Outcome, Outcome, Timepoint
Primary Outcome(s) 1
Type of Primary Outcome	/Safety/Efficacy
Outcome	Severity of dizziness symptoms
Timepoint	Baseline, Week 3, Month 1, Month 3
Secondary Outcome(s) 1
Outcome	Adverse events
Timepoint	Evaluation after every brain stimulation session
Secondary Outcome(s) 2
Outcome	Single-photon emission computed tomography Imaging
Timepoint	Baseline, Week 3

11. Study Results and Publication

Study Results and Publication Information - Result Registered, Final Enrollment Number, Number of Publication, Publications, Results Upload, Date of Posting Results, Protocol URL or File Upload, Brief Summary
Result Registered	No

12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)

Sharing of Study Data Information - Sharing Statement, Time of Sharing, Way of Sharing
Sharing Statement	No

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