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

NCT ID: NCT05613634

Last Updated: 2022-11-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-10
• Study Completion Date: 2022-10-10

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Study group

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

Group Type: EXPERIMENTAL

Repetitive transcranial magnetic stimulation

Intervention Type: 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.

Cawthorne Cooksey exercises

Intervention Type: 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

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

Group Type: EXPERIMENTAL

Cawthorne Cooksey exercises

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

October 6 University

OTHER

Sponsor Role: lead

Responsible Party

Hosam Magdy Metwally

Hosam.Magdy.PT@o6u.edu.eg

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

October 6 University

Giza, , Egypt

Countries

Egypt

Other Identifiers

152947

Identifier Type: -

Identifier Source: org_study_id