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The Effect of Pinhole Glasses on Vestibular Electrical Stimulation

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: NCT05516017
Recruitment Status : Not yet recruiting
First Posted : August 25, 2022
Last Update Posted : October 4, 2022
Sponsor:
Information provided by (Responsible Party):
Huseyin Gezgin, Istanbul University

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Vertigo, Peripheral Device: Vestibular Electrical Stimulator and Pinhole Glasses Device: Vestibular Electrical Stimulator Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of Pinhole Glasses on Vestibular Electrical Stimulation Used in the Treatment of Chronic Unilateral Vestibular Hypofunction: A Randomized Controlled Study
Estimated Study Start Date : October 15, 2022
Estimated Primary Completion Date : July 15, 2023
Estimated Study Completion Date : August 15, 2023

Resource links provided by the National Library of Medicine


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.

Device: Vestibular Electrical Stimulator and Pinhole Glasses

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.

Device: Vestibular Electrical Stimulator
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.




Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT05516017


Contacts
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Contact: Hüseyin Gezgin, Md. 05456769538 huseyingezgin314@gmail.com

Sponsors and Collaborators
Istanbul University
Investigators
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Study Director: Ayşe Karan, Prof Dr. Istanbul University
Publications of Results:
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Responsible Party: Huseyin Gezgin, Principal Investigator, Istanbul University
ClinicalTrials.gov Identifier: NCT05516017    
Other Study ID Numbers: Istanbul Unversity, Istanbul
First Posted: August 25, 2022    Key Record Dates
Last Update Posted: October 4, 2022
Last Verified: October 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Huseyin Gezgin, Istanbul University:
vestibular electrical stimulation, pinhole glasses
Additional relevant MeSH terms:
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Vertigo
Vestibular Diseases
Labyrinth Diseases
Ear Diseases
Otorhinolaryngologic Diseases
Neurologic Manifestations
Nervous System Diseases