Effect of Repetitive Transcranial Magnetic Stimulation in Patients With Peripheral Vestibular Dysfunction

NCT05613634 | Completed

• 1 other identifier: 152947
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

Background: Vestibular dysfunctions are common disorders in the adult population that can develop at any life decade. Most of the patients with vestibular dysfunction suffer from balance disorders and vertigo that may have a negative impact on daily living activities and social participation. Objectives: To investigate the effect of repetitive transcranial magnetic stimulation added to vestibular physical therapy exercises on functional recovery in patients with vestibular dysfunction. Hypothesis: There is no effect of repetitive transcranial magnetic stimulation added to vestibular physical therapy exercises on functional recovery in patients with vestibular dysfunction.

Conditions

Peripheral Vestibular Dysfunction

Keywords

Vestibular dysfunction, repetitive transcranial magnetic stimulation, vestibular physical therapy exercises, vertigo, Activities of daily living.

Outcome Measures

Primary Outcomes (1)

• Video-nystagmography (VNG)

  The VNG was used to assess unilateral vestibular canal weakness. It was used with caloric testing to analyze eye movements using video imaging technology, in which hi-tech video goggles with infrared cameras were used

  35 minutes

Secondary Outcomes (1)

• Dizziness handicap inventory (DHI)

  20 minutes

Study Arms (2)

Study group

EXPERIMENTAL

The study group received rTMS in addition to the vestibular physical therapy exercises

Device: Repetitive transcranial magnetic stimulation; Other: Cawthorne Cooksey exercises

Control group

EXPERIMENTAL

Patients in control group received the vestibular physical therapy exercises, three sessions a week for four weeks

Other: Cawthorne Cooksey exercises

Interventions

Repetitive transcranial magnetic stimulation DEVICE

A high frequency (10 Hz) rTMs on the dominant dorsolateral prefrontal cortex (DLPFC) was applied with the Magstim Rapid Magnetic Stimulator, Magstim Company. Patients were seated in a chair, arms and legs relaxed, head stable, and no movement was allowed during the procedure. Motor threshold (MT) was determined before each session and was defined as the percent intensity output of the stimulator that generated a 50µV motor evoked response in the abductor pollicis brevis (APB) muscle in five out of 10 trials. The DLPFC of dominant hemisphere was localized on the scalp 5.5 cm anterior to the hot spot for the contralateral APB muscle along the parasagittal plane. The average MT was 50 % (range, 45-55%) of the maximal output of the stimulator. The initial mapping procedure was completed with the coil oriented at 45° lateral diagonal orientation roughly perpendicular to the central sulcus and the center of the coil applied tangentially to the scalp.

Study group

Cawthorne Cooksey exercises OTHER

Cawthorne Cooksey exercises were carried in the following sequence: First, bed exercises; eye movements (up and down, side to side, focusing on a finger that is one feet distance); head movements (bending up and down, side to side first with eye opened then closed). Second, sitting exercises involved same eye and head movements, shoulder shrugging, turning head and trunk alternately to the right and left, bending head and trunk forward, and pick an object from the ground. Third, standing exercises involved same eye, head, and shoulder movements, changing position from sitting to standing with eye open then closed, throw a ball from hand to hand above eye level, throw a ball from hand to hand beneath knee, changing position from sitting to standing and turn around in between. Fourth, moving around exercises where the patient revolved around a person sitting in the center who throw him a ball and to whom it was returned.

Control group; Study group

Eligibility Criteria

• Age: 30 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• patients diagnosed by an audiologist with a chronic uncompensated unilateral peripheral vestibular weakness
• age ranged from 30 to 60 years, and duration of illness ranged from 4 to 32 months

You may not qualify if:

• benign paroxysmal positional vertigo
• bilateral peripheral vestibular weakness
• central vestibular disorders
• acute vestibular weakness
• vertigo of vascular origin (Vertebrobasilar insufficiency) or cervical origin

Sponsors & Collaborators

• October 6 University: lead

Study Sites (1)

October 6 University

Giza, 12573, Egypt

Location

MeSH Terms

Conditions

Vertigo

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Hosam.Magdy.PT@o6u.edu.eg

Study Record Dates

• First Submitted: November 6, 2022
• First Posted: November 14, 2022
• Study Start: May 10, 2022
• Primary Completion: August 10, 2022
• Study Completion: October 10, 2022
• Last Updated: November 14, 2022

Record last verified: 2022-11

Locations

EG (1)