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

Effect of Repetitive Transcranial Magnetic Stimulation on Vestibular Function and Self-rated Functional Recovery in Patients With Peripheral Vestibular Dysfunction

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.

Study Overview

• Status: Completed
• Conditions: Peripheral Vestibular Dysfunction
• Intervention / Treatment: Device: Repetitive transcranial magnetic stimulation; Other: Cawthorne Cooksey exercises

• Study Type: Interventional
• Enrollment (Actual): 35
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Giza, Egypt, 12573
    • October 6 University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 26 years to 56 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Study group; The study group received rTMS in addition to the vestibular physical therapy exercises	Device: Repetitive transcranial magnetic stimulation; 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.; Other: Cawthorne Cooksey exercises; 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.
Experimental: Control group; Patients in control group received the vestibular physical therapy exercises, three sessions a week for four weeks	Other: Cawthorne Cooksey exercises; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dizziness handicap inventory (DHI)	is used in clinical work and in research to assess the impact of dizziness on QoL. The self-report questionnaire was designed to quantify the handicapping effect of dizziness imposed by vestibular system disease. The Arabic version of the DHI has good validity and reliability for assessing patients' self-perception of the handicap and its impact on their QoL	20 minutes

Collaborators and Investigators

• Sponsor: October 6 University

Study record dates

Study Major Dates

• Study Start (Actual): May 10, 2022
• Primary Completion (Actual): August 10, 2022
• Study Completion (Actual): October 10, 2022

Study Registration Dates

• First Submitted: November 6, 2022
• First Submitted That Met QC Criteria: November 6, 2022
• First Posted (Actual): November 14, 2022

Study Record Updates

• Last Update Posted (Actual): November 14, 2022
• Last Update Submitted That Met QC Criteria: November 6, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: Vestibular dysfunction, repetitive transcranial magnetic stimulation, vestibular physical therapy exercises, vertigo, Activities of daily living.
• Other Study ID Numbers: 152947

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No