to investigate the combined effect of vestibular rehabilitation and transcranial direct current stimulation (tDCS) in comparison with vestibular rehabilitation alone on improving the balance symptoms in adults with peripheral vertigo
Design
This is a randomized clinical trial that adults with peripheral vertigo will be randomly assigned to intervention groups 1 and intervention 2.
Settings and conduct
Place: Imam Khomeini Hospital, Ahvaz Transcranial Direct Current Stimulation (tDCS) will be applied via two electrodes using 2mA intensity and 20-minutes duration. The anode and cathode electrodes were placed over the right (T4) and left (T3) auditory cortex sites. All patients undergo vestibular rehabilitation treatment (VRT) using the EPLEY approach.
Dizziness Handicap Inventory (DHI) questionnaire: This questionnaire is designed to assess the effect of balance problems on the emotional, functional and physical dimensions of the patient's life with imbalance. The score of the questionnaire is between zero and 100, with higher values indicating more disability. VRT and tDCS Stimulation will be applied on 5 weekdays during a TWO-week period (10 sessions) and DHI results will be compared at pre-intervention, 1-week post-intervention and 2-week post-intervention time-points.
Participants/Inclusion and exclusion criteria
Inclusion criteria: chronic peripheral vertigo; age: 20-40 yr
Exclusion criteria: history of cervical problem, psychiatric disorders, and epileptic seizures and brain trauma
Intervention groups
1- Group who only received vestibular rehabilitation in combination with tDCS therapy (VRT+tDCS)
2- Group who only received estibular rehabilitation therapy (VRT)
Main outcome variables
Balance problems (emotional, functional and physical dimensions)
General information
Reason for update
Acronym
tDCS & VRT
IRCT registration information
IRCT registration number:IRCT20200820048467N2
Registration date:2021-08-18, 1400/05/27
Registration timing:prospective
Last update:2021-08-18, 1400/05/27
Update count:0
Registration date
2021-08-18, 1400/05/27
Registrant information
Name
Arash Bayat
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3374 3506
Email address
arashbayat2004@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-08-23, 1400/06/01
Expected recruitment end date
2022-03-03, 1400/12/12
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of Transcranial direct current stimulation (tDCS) on balance function in adults with peripheral vertigo
Public title
effects of electrical stimulation on balance function in adults
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Chronic peripheral vertigo
Adult
Exclusion criteria:
History of brain/head trauma
History of neck problem
History of psychiatric disorders
History of epileptic seizures
Age
From 18 years old to 40 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Random assignment of patients to intervention and control groups by lot. For this purpose, we prepare two sheets and write "Intervention " on one and "CONTROL" on the other. Then, with each patient's visit, one of the sheets is randomly removed and the patient is assigned to intervention group or CONTROL group.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Ahvaz University of Medical Sciences
Street address
Golestan Street, Medical university
City
Ahvaz
Province
Khouzestan
Postal code
6193673111
Approval date
2021-05-22, 1400/03/01
Ethics committee reference number
IR.AJUMS.REC.1400.116
Health conditions studied
1
Description of health condition studied
Peripheral vertigo
ICD-10 code
H81.39
ICD-10 code description
Other peripheral vertigo
Primary outcomes
1
Description
Balance problems (emotional, functional and physical dimensions)
Timepoint
5 weekdays sessions during a TWO-week period (10 sessions)
Intervention group: Group who received tDCS in combination with vestibular rehabilitation therapy (VRT+tDCS). VRT and tDCS Stimulation therapy will be applied on 5 weekdays during a TWO-week period (10 sessions). The tDCS will be applied via two electrodes using 2mA intensity and 20-minutes duration. The anode and cathode electrodes were placed over the right (T4) and left (T3) auditory cortex sites. Furthermore, all patients undergo VRT using the EPLEY approach.
Category
Rehabilitation
2
Description
Control group: Group who received only vestibular rehabilitation therapy (VRT). VRT therapy will be applied on 5 weekdays during a TWO-week period (10 sessions) using EPLEY method.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital, Ahvaz
Full name of responsible person
Arash bayat
Street address
Department of ENT, Imam Khomeini Hospital, Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
61375-33133
Phone
+98 61 3374 3102
Email
arashbayat2004@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Dr. Mehdi Ahmadi Moghadam (Vice President for Research, Ahvaz University of Medical Sciences)
Street address
Research Deputy, Ahvaz Jundishapur University of Medical Sciences, Golestan Blv., Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
61375-33133
Phone
+98 61 3374 3102
Fax
Email
arashbayat2004@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Arash Bayat
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Audiology
Street address
Department of Audiology, Rehabilitation school, Ahvaz Jumdishapur University of Medical Sciences, Golstan Area, Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
61357-33133
Phone
+98 61 3374 3102
Email
arashbayat2004@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Arash Bayat
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Audiology
Street address
Rehabilitation School, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran; Postal code: 61357-33133
City
Ahvaz
Province
Khouzestan
Postal code
61375-33133
Phone
+98 61 3374 3506
Fax
Email
arashbayat2004@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Arash Bayat
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Audiology
Street address
Rehabilitation School, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran; Postal code: 61357-33133
City
Ahvaz
Province
Khouzestan
Postal code
61375-33133
Phone
+98 61 3374 3506
Fax
Email
arashbayat2004@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
All statistical files and questionnaires are accessible (names are coded)
When the data will become available and for how long
from ARTICLE publishing
To whom data/document is available
Researchers in the field of vestibular
Under which criteria data/document could be used
Research and treatment purposes
From where data/document is obtainable
Hearing research center, AJUMS
What processes are involved for a request to access data/document
1- Send your request to the University of Medical Sciences, AFTER APPROVAL 2- Hearing research center