Peripheral Vestibular DysfunctionNCT05613634
Effect of Repetitive Transcranial Magnetic Stimulation in Patients With Peripheral Vestibular Dysfunction
A study testing Repetitive transcranial magnetic stimulation and Cawthorne Cooksey exercises in people with Peripheral Vestibular Dysfunction, run by October 6 University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 60 years
- Conditions the study is for
- Peripheral Vestibular Dysfunction
- What is being tested?
- Repetitive transcranial magnetic stimulation and Cawthorne Cooksey exercises
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteEgypt
- Study dates
- 10 May 2022to 10 Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- benign paroxysmal positional vertigo
- bilateral peripheral vestibular weakness
- central vestibular disorders
- acute vestibular weakness
- vertigo of vascular origin (Vertebrobasilar insufficiency) or cervical origin
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Peripheral Vestibular Dysfunction
- Being tested
- Repetitive transcranial magnetic stimulation, Cawthorne Cooksey exercises
- Keywords
- Vestibular dysfunction, repetitive transcranial magnetic stimulation, vestibular physical therapy exercises, vertigo, Activities of daily living.
- Medical subject headings
- Vertigo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Repetitive transcranial magnetic stimulationDevice
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 exercisesOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Study group | Experimental | The study group received rTMS in addition to the vestibular physical therapy exercises Receives: 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 Receives: Other: Cawthorne Cooksey exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 35 minutes
Secondary outcomes (1)
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
Measured: 20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2022
- Study start10 May 2022
- Primary completion10 Aug 2022
- Study completion10 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Vestibular DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- October 6 University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hosam Magdy Metwally, October 6 University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05613634
- Sponsor's protocol ID
- 152947
- Status last verified
- Nov 2022
- First submitted
- 6 Nov 2022
- Last updated
- 14 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Repetitive Transcranial Magnetic Stimulation on Vestibular Function and Self-rated Functional Recovery in Patients With Peripheral Vestibular Dysfunction
- ClinicalTrials.gov ID
- NCT05613634
- Acronym / sponsor ID
- 152947
- Conditions
- Peripheral Vestibular Dysfunction
- Keywords
- Vestibular dysfunction, repetitive transcranial magnetic stimulation, vestibular physical therapy exercises, vertigo, Activities of daily living.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- October 6 UniversityUniversity, hospital or other
- Study start
- 10 May 2022 (actual)
- Primary completion
- 10 Aug 2022 (actual)
- Study completion
- 10 Oct 2022 (actual)
- First posted
- 14 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study group | Experimental | Device: Repetitive transcranial magnetic stimulation, Other: Cawthorne Cooksey exercisesThe study group received rTMS in addition to the vestibular physical therapy exercises |
| Control group | Experimental | Other: Cawthorne Cooksey exercisesPatients in control group received the vestibular physical therapy exercises, three sessions a week for four weeks |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (5 listed)
- benign paroxysmal positional vertigo
- bilateral peripheral vestibular weakness
- central vestibular disorders
- acute vestibular weakness
- vertigo of vascular origin (Vertebrobasilar insufficiency) or cervical origin
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Repetitive transcranial magnetic stimulationA 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. | Device | Study group |
| Cawthorne Cooksey exercisesCawthorne 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. | Other | Control group, Study group |
Primary outcome
Video-nystagmography (VNG)
Time frame: 35 minutes
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
1 secondary outcome
Dizziness handicap inventory (DHI)
Time frame: 20 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2022.
- Individual participant dataSharing planned: Undecided
Related trials for Peripheral Vestibular Dysfunction
Recruiting
Spatial Orientation, Navigation, and Neuropsychologic Function in Patients With Vestibular Implant
Vestibular Dysfunction, Bilateral Vestibular Loss
Not yet recruiting
Ai Chi-Based Rehabilitation for Peripheral Unilateral Vestibular Dysfunction
Unilateral Peripheral Vestibular Hypofunction, Vestibular Disorders
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Repetitive transcranial magnetic stimulation and Cawthorne Cooksey exercises in people with Peripheral Vestibular Dysfunction, run by October 6 University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Video-nystagmography (VNG) (time frame: 35 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2022.