- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05516017
The Effect of Pinhole Glasses on Vestibular Electrical Stimulation
The Effect of Pinhole Glasses on Vestibular Electrical Stimulation Used in the Treatment of Chronic Unilateral Vestibular Hypofunction: A Randomized Controlled Study
Balance is the ability to control and maintain the body's center of gravity within the support area. One of the important causes of imbalance is right or left sided unilateral vestibular hypofunction. Chronic vestibular hypofunction describes the loss of unilateral peripheral vestibular function lasting more than 3 months. VES is an important method for replacing the sensory afferents lost in the sudden onset of unilateral vestibular hypofunction and for the correct processing of information in the balance center. Regarding the mechanism of action of Vestibular Electrical Stimulation (VES), it is suggested that it generally affects the auditory system at various levels.
Study aimed which was planned as a prospective, randomized, single-blind and single-center study, was conducted between 1 September 2022 and 1 July 2023, to Istanbul University, Istanbul Faculty of Medicine, Department of Physical Medicine and Rehabilitation, Vertigo Rehabilitation Outpatient Clinic with chronic vestibular hypofunction and the inclusion criteria. It was planned to include at least 100 matching patients. Participants who meet the inclusion criteria will be randomized into two groups by computer program after they are numbered according to the order of application. VES and exercise therapy will be applied by wearing pinhole glasses to 50 participants selected to Group 1 (G1-Experimental group). VES and exercise therapy without wearing pinhole glasses in 50 participants selected in Group 2 (G2-Control group) will be applied. Before and after the treatment, the severity of dizziness due to vestibular hypofunction, their emotional state, functionality and physical state and balance status will be evaluated. Dizziness severity will be evaluated with a visual analog scale, and emotional status, functionality and physical condition will be evaluated with the Dizziness Disability Inventory (DHI). Balance status will be determined by Tandem Gait Test, Timed Up and Go Test and Berg Balance Test. Evaluations will be made before treatment, at 1 month of treatment, and at 3 months of treatment (1 month after the end of treatment) by another study blind to treatment.
With the data provided as a result of the research, it has contributed to both our country and the world literature, besides vestibular electrical stimulation, which can be used in the treatment of vestibular hypofunction, we will draw attention to the effectiveness of the use of pinhole glasses.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Hüseyin Gezgin, Md.
- Phone Number: 05456769538
- Email: huseyingezgin314@gmail.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Unilateral vestibular hypofunction
- Those who complain of dizziness for more than three months
- Meniere's disease
- Age-related vestibular hypofunction
- Sequelae of vestibular neuritis
- Patients diagnosed with vertigo after surgical trauma
Exclusion Criteria:
- Central cause of vertigo (necessary during the examination Neurology and ENT To be evaluated by the department)
- History of orthostatic hypotension, psychosomatic disorder, heart disease, cerebrovascular disease, migraine, tumoral disease
- Advanced cervical spondylosis on direct radiographs (excluded from the outpatient clinic) the future)
- History of major surgical intervention in the head and neck region
- Detection of anemia in complete blood count
- Having more than 6 degrees of myopia
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Vestibular Electrical Stimulation and exercises with pinhole glasses
For VES, which we will apply in our study, the anode will be placed on the mastoid protrusion on the sick ear and a cathode electrode is placed on the healthy ear.The skin to be treated will be cleaned and dried The electrodes are fixed to the head with the help of an elastic band. VES application per session will be applied for 30 minutes, 2 days a week, for 8 weeks. Patients will be asked to perform a bed exercise program once a day for 20-30 minutes each session, 5 days a week, for 8 weeks, including the above exercises, which they will perform in bed after the first day.These exercises are; fixation of the head and turning the eyes to the right and left, the movement of fixing the eyes and turning the head to the left and right, turning the head and eyes in one direction and focusing, hip flexor and knee extensor strengthening. Patients in the experimental group will also wear pinhole glasses while applying VES. |
It is applied with a vestibular electrical stimulation device for 20 msec with 2 Hz, 1-4 mA, 1 mA increments. Very high frequencies can cause auditory perceptions such as 0.5 - 20 kHz, should be avoided. The pinhole glasses are made of 2 pieces of opaque black plastic material with a total of 113 holes on each side. The opaque black plastic is 1.7 mm thick, 4.5 cm wide, and 5.5 cm long. The holes in the opaque black material are arranged horizontally in 11 rows from top to bottom. The diameter of each hole is 1.1 mm, the horizontal distance of the holes from each other is 4.5 mm, and the vertical distance is 3.5 mm. |
Active Comparator: VES and exercises without pinhole glasses
For VES, which we will apply in our study, the anode will be placed on the mastoid protrusion on the sick side and the cathode will be placed on the healthy ear. The skin to be treated will be cleaned and dried. The electrodes are fixed to the head with the help of an elastic band. VES application per session will be applied for 30 minutes, 2 days a week, for 8 weeks.Patients will be asked to perform a bed exercise program once a day for 20-30 minutes each session, 5 days a week, for 8 weeks, including the above exercises, which they will perform in bed after the first day.These exercises are; fixation of the head and turning the eyes to the right and left, the movement of fixing the eyes and turning the head to the left and right, turning the head and eyes in one direction and focusing, hip flexor and knee extensor strengthening. Patients in the active comparator will not wear pinhole glasses while VES is applied. |
It is applied with a vestibular electrical stimulation device for 20 msec with 2 Hz, 1-4 mA, 1 mA increments.
Very high frequencies can cause auditory perceptions such as 0.5 - 20 kHz, should be avoided.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Dizziness Handicap Inventory (DHI)
Time Frame: Evaluation will be done at baseline (before treatment), at the 1st month and at the 3rd month of the treatment
|
It is a scale that shows the degree of impact on quality of life, emotional status and functionality in patients with dizziness and balance disorders.
The form developed by Newman and Jacobson includes 25 items that evaluate the problems related to dizziness: 9 questions question functionality, 9 questions emotional state, and 7 questions physical state.
Questions are answered by ticking one of the options no, sometimes yes.
No answer counts as 0 points, sometimes 2 points and yes answers as 4 points.
|
Evaluation will be done at baseline (before treatment), at the 1st month and at the 3rd month of the treatment
|
Change in Dizziness Severity Evaluated by Visual Analog Scale
Time Frame: Evaluation will be done at baseline (before treatment), at the 1st month and at the 3rd month of the treatment
|
It is a subjective measurement made to determine the severity of the patient's dizziness by the patient.
For the measurement, the definition of the parameter to be evaluated - the severity of dizziness in our study - is written on the ends of the 10 cm long line and the patients are asked to mark their own condition.
|
Evaluation will be done at baseline (before treatment), at the 1st month and at the 3rd month of the treatment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Berg Balance Scale
Time Frame: Evaluation will be done at baseline (before treatment), at the 1st month and at the 3rd month of the treatment
|
It is a scale created mainly for the evaluation of balance and determining the risk of falling in the elderly.
It consists of 14 items scored between 0-4.
The highest possible score is 56.
A low score indicates greater risk of falling and loss of balance.
|
Evaluation will be done at baseline (before treatment), at the 1st month and at the 3rd month of the treatment
|
Change in Timed Up and Go Test (TUG)
Time Frame: Evaluation will be done at baseline (before treatment), at the 1st month and at the 3rd month of the treatment
|
The patient sits in a chair and a target is set 3 meters ahead.
The patient is asked to get up from the chair, walk to the target, come back and sit on the chair again.
The elapsed time is recorded.
If it lasts longer than 12 seconds, the patient has a risk of falling.
|
Evaluation will be done at baseline (before treatment), at the 1st month and at the 3rd month of the treatment
|
Change in Tandem Walking
Time Frame: Evaluation will be done at baseline (before treatment), at the 1st month and at the 3rd month of the treatment
|
The patient is asked to walk on a straight line drawn on the ground, with the toe of one foot touching the heel of the other foot.
How many steps he can take is recorded.
|
Evaluation will be done at baseline (before treatment), at the 1st month and at the 3rd month of the treatment
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Ayşe Karan, Prof Dr., Istanbul University
Publications and helpful links
General Publications
- Karan A, Alptekin HK, Çapan N, Dıraçoğlu D, Saral İ, Aydın S, Aksoy C. The efficacy of vestibular electrical stimulation on patients with unilateral vestibular pathologies. Turk J Phys Med Rehabil. 2017 Jun 3;63(2):149-154. doi: 10.5606/tftrd.2017.267. eCollection 2017 Jun.
- Rizzo-Sierra CV, Gonzalez-Castaño A, Leon-Sarmiento FE. Galvanic vestibular stimulation: a novel modulatory countermeasure for vestibular-associated movement disorders. Arq Neuropsiquiatr. 2014 Jan;72(1):72-7. doi: 10.1590/0004-282X20130182. Review.
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Istanbul Unversity, Istanbul
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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