The Effect of Pinhole Glasses on Vestibular Electrical Stimulation

NCT05516017 | Unknown

• 1 other identifier: Istanbul Unversity, Istanbul
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Vertigo, Peripheral

Keywords

vestibular electrical stimulation, pinhole glasses

Outcome Measures

Primary Outcomes (2)

• Change in Dizziness Handicap Inventory (DHI)

  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

  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 Outcomes (3)

• Change in Berg Balance Scale

  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)

  Evaluation will be done at baseline (before treatment), at the 1st month and at the 3rd month of the treatment

• Change in Tandem Walking

  Evaluation will be done at baseline (before treatment), at the 1st month and at the 3rd month of the treatment

Study Arms (2)

Vestibular Electrical Stimulation and exercises with pinhole glasses

EXPERIMENTAL

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

VES and exercises without pinhole glasses

ACTIVE COMPARATOR

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

Interventions

Vestibular Electrical Stimulator and Pinhole Glasses DEVICE

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.

Vestibular Electrical Stimulation and exercises with pinhole glasses

Vestibular Electrical Stimulator DEVICE

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.

VES and exercises without pinhole glasses

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istanbul University: lead

Related Publications (2)

• Karan A, Alptekin HK, Capan N, Diracoglu D, Saral I, Aydin 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.

  PMID: 31453443 RESULT

• Rizzo-Sierra CV, Gonzalez-Castano 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.

  PMID: 24637984 RESULT

MeSH Terms

Conditions

Vertigo

Condition Hierarchy (Ancestors)

Vestibular Diseases; Labyrinth Diseases; Ear Diseases; Otorhinolaryngologic Diseases; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Ayşe Karan, Prof Dr.

  Istanbul University

  STUDY DIRECTOR

Central Study Contacts

Hüseyin Gezgin, Md.

CONTACT

05456769538; huseyingezgin314@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 24, 2022
• First Posted: August 25, 2022
• Study Start: October 15, 2022
• Primary Completion: July 15, 2023
• Study Completion: August 15, 2023
• Last Updated: October 4, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share