Peripheral Vestibular DisordersrTMSNCT05871385
rTMS Plus Vestibular Rehabilitation as an Adjunct Treatment for Fall Risk and Postural Instability for Chronic Vestibular Dizziness Patients/ Chronic Labyrinthitis
A study testing rTMS group in people with Peripheral Vestibular Disorders, run by Beni-Suef University at 2 sites in Egypt.
Trial summary
Falling is one of the most common consequences of vestibular dizziness. Most of patients with vestibular dysfunction suffer from balance disorders, postural instability and vertigo that may lead to life threating complications as fractures and brain injuries. Read more about this study
- Who is it for?
- Ages 45 to 70 years
- Conditions the study is for
- Peripheral Vestibular Disorders
- What is being tested?
- rTMS group
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- 2 sitesEgypt
- Study dates
- 23 Apr 2023to 27 Dec 2023
- 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 45 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis with peripheral vestibular disorders from audiologist or neurologist.
- The patient's age will be ranged from forty five to seventy years old.
- Patients will experience at least two symptoms of common symptoms of peripheral vestibular disorders.
- Symptoms of vertigo and nystagmus lasting from seconds to one minute.
- Vertigo that arises from changes in head position related to gravity.
- Patients who experienced symptoms for more than three months (chronic patients)
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- Patients were selected to be ambulant.
- Patients suffer from balance disturbance with low risk falling (41-56) and moderate risk falling ranges (21-40) according to berg balance scale.
- All patients were medically stable, controlled with medical drugs for at least three months and failed to medical treatment with no other physical, mental or cognitive disorders.
Who cannot join
- Central vestibular disorders ( Ms, ataxia, migraine headache, posterior inferior cerebellar artery syndrome "PICA").
- Vertigo that arises from changes in head position not related to gravity; as vertigo of cervical origin or vascular origin ( Vertebro- basilar insufficiency "VBI").
- Previous surgery of the ear.
- Bilateral peripheral vestibular weakness, central vestibular weakness, mixed vestibular weakness, or acute vestibular weakness.
- Unstable health issues (cardiac dysfunction, end stage renal failure, unstable diabetes, uncontrolled hypertension >190/110…).
- Pacemaker or other implanted electrically sensitive device.
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- Significant orthopedic or chronic pain syndrome (e.g any condition that wouldn't permit to completion of any of the tests).
- Major cognitive dysfunction. neurodegenerative disease or major psychiatric condition ( Alzheimer's disease , depression….).
- Chronic use of medications that could influence motor or sensory excitability (e.g AEDs, antipsychotic).
- Alcohol abuse.
- Epilepsy.
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites
Cairo University Hospitals
Cairo
faculty of medicine , Cairo University
Cairo
About this study
Official title: rTMS Plus Vestibular Rehabilitation as an Adjunct Treatment for Fall Risk and Postural Instability for Chronic Vestibular Dizziness Patients, Double Blinded RCT
Falling is one of the most common consequences of vestibular dizziness. Most of patients with vestibular dysfunction suffer from balance disorders, postural instability and vertigo that may lead to life threating complications as fractures and brain injuries. Non invasive brain stimulation techniques such as repetitive transcranial magnetic stimulation (rTMS) have been investigated as therapeutic interventions for various neurological disorders like motor deficits and balance disorders after various neurological deficits. To investigate the effect of repetitive transcranial magnetic stimulation (rTMS) added to supervised vestibular rehabilitation program on balance and postural stability in patients with vestibular dizziness
Read the detailed description
The subjects of both genders with age 40 to 65 will be allocated randomly into two equal groups A and B. Group A Outcomes measure will include : Berg balance scale, computerized dynamic posturography (CDP) . Assessment will be done before and after treatment sessions.
- Conditions
- Peripheral Vestibular Disorders
- Being tested
- rTMS group, placebo rTMS group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rTMS groupDevice
Also called repetitive transcranial magnetic stimulation
Twenty eight randomly assigned patients with peripheral vestibular disorders will undergo 10 Hz rTMS to the dorsolateral prefrontal cortex of their dominant hemisphere; in addition to designed vestibular rehabilitation exercises
placebo rTMS groupDevice
Also called placebo rTMS
Twenty eight randomly assigned patients with peripheral vestibular disorders will undergo placebo rTMS plus designed vestibular rehabilitation exercises.
| Study group | Role | What they receive |
|---|---|---|
| Group A (r TMS group) | Experimental | Twenty eight randomly assigned patients with peripheral vestibular disorders will undergo 10 Hz rTMS to the dorsolateral prefrontal cortex of their dominant hemisphere; in addition to designed vestibular rehabilitation exercises.
Device: repetitive transcranial magnetic stimulation high frequency (10 HZ) rTMS pulses are applied to the dorsolateral prefrontal cortex of the dominant hemisphere. Receives: Device: rTMS group |
| Control (Group B) (placebo rTMS) | Placebo comparator | Twenty eight randomly assigned patients with peripheral vestibular disorders will undergo placebo rTMS plus designed vestibular rehabilitation exercises. Receives: Device: placebo rTMS group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postural stability
Computerized dynamic Posturography- Scores ranging zero min score and 100 max score
Measured: change from baseline to 8 weeks after intervention
Visual Vertigo Analogue Scale
Indicate the amount of dizziness you experience in different situations
Measured: change from baseline to 8 weeks after intervention
Secondary outcomes (1)
Berg balance scale
Balance
- 14 items each item scored from zero (min score)-4 (Max score) with total min score zero and max score 56
Measured: change from baseline to 8 weeks after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2023
- Study start23 Apr 2023
- Primary completion27 Dec 2023
- Study completion27 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Vestibular DisordersStudies of the same condition, open and under way.
- More trials run by Beni-Suef UniversityThe sponsor's other registered studies.
- 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beni-Suef University
- Sponsor type
- University, hospital or other
- Collaborators
- Cairo University
- Responsible party
- Principal investigator, Ahmed Samir Abdelkhalik Youssef, Beni-Suef University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05871385
- Sponsor's protocol ID
- P.T.REC/012/002202
- Acronym
- rTMS
- Status last verified
- Jan 2025
- First submitted
- 22 Apr 2023
- Last updated
- 6 Jan 2025
- 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 6 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- rTMS Plus Vestibular Rehabilitation as an Adjunct Treatment for Fall Risk and Postural Instability for Chronic Vestibular Dizziness Patients, Double Blinded RCT
- ClinicalTrials.gov ID
- NCT05871385
- Acronym / sponsor ID
- rTMS / P.T.REC/012/002202
- Conditions
- Peripheral Vestibular Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Beni-Suef UniversityUniversity, hospital or other
- Collaborators
- Cairo University
- Study start
- 23 Apr 2023 (actual)
- Primary completion
- 27 Dec 2023 (actual)
- Study completion
- 27 Dec 2023 (actual)
- First posted
- 23 May 2023 (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.
Falling is one of the most common consequences of vestibular dizziness. Most of patients with vestibular dysfunction suffer from balance disorders, postural instability and vertigo that may lead to life threating complications as fractures and brain injuries. Non invasive brain stimulation techniques such as repetitive transcranial magnetic stimulation (rTMS) have been investigated as therapeutic interventions for various neurological disorders like motor deficits and balance disorders after various neurological deficits. To investigate the effect of repetitive transcranial magnetic stimulation (rTMS) added to supervised vestibular rehabilitation program on balance and postural stability in patients with vestibular dizziness
Detailed description
The subjects of both genders with age 40 to 65 will be allocated randomly into two equal groups A and B. Group A Outcomes measure will include : Berg balance scale, computerized dynamic posturography (CDP) . Assessment will be done before and after treatment sessions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A (r TMS group) | Experimental | Device: rTMS groupTwenty eight randomly assigned patients with peripheral vestibular disorders will undergo 10 Hz rTMS to the dorsolateral prefrontal cortex of their dominant hemisphere; in addition to designed vestibular rehabilitation exercises. Device: repetitive transcranial magnetic stimulation high frequency (10 HZ) rTMS pulses are applied to the dorsolateral prefrontal cortex of the dominant hemisphere. |
| Control (Group B) (placebo rTMS) | Placebo comparator | Device: placebo rTMS groupTwenty eight randomly assigned patients with peripheral vestibular disorders will undergo placebo rTMS plus designed vestibular rehabilitation exercises. |
Who may qualify
- Ages
- 45 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Diagnosis with peripheral vestibular disorders from audiologist or neurologist.
- The patient's age will be ranged from forty five to seventy years old.
- Patients will experience at least two symptoms of common symptoms of peripheral vestibular disorders.
- Symptoms of vertigo and nystagmus lasting from seconds to one minute.
- Vertigo that arises from changes in head position related to gravity.
Key exclusion criteria (11 listed)
- Central vestibular disorders ( Ms, ataxia, migraine headache, posterior inferior cerebellar artery syndrome "PICA").
- Vertigo that arises from changes in head position not related to gravity; as vertigo of cervical origin or vascular origin ( Vertebro- basilar insufficiency "VBI").
- Previous surgery of the ear.
- Bilateral peripheral vestibular weakness, central vestibular weakness, mixed vestibular weakness, or acute vestibular weakness.
- Unstable health issues (cardiac dysfunction, end stage renal failure, unstable diabetes, uncontrolled hypertension >190/110…).
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 |
|---|---|---|
| rTMS groupAlso: repetitive transcranial magnetic stimulationTwenty eight randomly assigned patients with peripheral vestibular disorders will undergo 10 Hz rTMS to the dorsolateral prefrontal cortex of their dominant hemisphere; in addition to designed vestibular rehabilitation exercises | Device | Group A (r TMS group) |
| placebo rTMS groupAlso: placebo rTMSTwenty eight randomly assigned patients with peripheral vestibular disorders will undergo placebo rTMS plus designed vestibular rehabilitation exercises. | Device | Control (Group B) (placebo rTMS) |
Primary outcome
Postural stability
Time frame: change from baseline to 8 weeks after intervention
Computerized dynamic Posturography- Scores ranging zero min score and 100 max score
Visual Vertigo Analogue Scale
Time frame: change from baseline to 8 weeks after intervention
Indicate the amount of dizziness you experience in different situations
1 secondary outcome
Berg balance scale
Time frame: change from baseline to 8 weeks after intervention
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 6 Jan 2025.
- Individual participant dataSharing planned: Undecided
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing rTMS group in people with Peripheral Vestibular Disorders, run by Beni-Suef University at 2 sites 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 9 inclusion and 11 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 6 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. Some participants in this study may receive a placebo. 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?
Postural stability (time frame: change from baseline to 8 weeks after intervention). The study lists 2 primary outcomes in all. 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 6 Jan 2025.