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RecruitingNCT04010435Updated Feb 14, 2024

Influence of Central Versus Peripheral Vestibular Stimulation in Patients With Peripheral Vestibular Disorders

An interventional study of repetitive transcranial magnetic stimulation and Galvanic stimulation in Peripheral Vestibular Disorders, sponsored by Cairo University. Recruiting at 1 site in Egypt. Open to participants aged 30 Years to 60 Years. Per ClinicalTrials.gov, last updated 2024-02-14.

Sponsored by Cairo University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Dec 2024, 1 year 10 months ago, but the record still lists the study as recruiting.
  • Registered 5 months after the study started (first participant enrolled Feb 2019, registered Jul 2019).
  • Started Feb 2019; still recruiting 7 years 9 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
30 Years to 60 Years
Sex
All
01

Study summary

Vestibular disorders are disabling conditions that can have a major effect on functioning especially on daily activities and social participation. Latest epidemiological studies estimate that as many as 35% of adults aged 40 years or older had experienced some form of vestibular dysfunction. 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. The purpose of this study is to compare between rTMs stimulation and galvanic vestibular stimulation in patients with unilateral peripheral vestibular disorders.

Read the detailed description

A pilot study has been recruited to calculate sample size and determine rTMs protocol that will be utilized during the study were two protocols has been compared and according to pilot study results collaborated with literature review a established protocol has been utilized. The subjects of both genders with age 30 to 60 will be allocated randomly into three equal groups A, B and C. Group A Outcomes measure will include : VNG (videonystagmography), Dizziness handicapped inventory, Berg balance scale, Vestibular disorders activities of daily living scale(VADL). Assessment will be done before and after treatment sessions.

02

Conditions studied

  • Peripheral Vestibular Disorders

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03

In context

Vestibular Diseases

170 studies on the registry are indexed under Vestibular Diseases; 41 are open to participants now.

This study's planned enrollment of 60 is above the median of 46 across 127 interventional studies indexed under Vestibular Diseases.

Browse Vestibular Diseases studies →

Lead sponsor

Cairo University is the lead sponsor of 4,941 studies on the registry; 1,458 are open to participants now.

Of its 37 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
30 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Definite diagnosis with unilateral peripheral vestibular disorders from audiologist or neurologist.
  2. The patient's age will be ranged from thirty to sixty years old.
  3. Patients will experience at least two symptoms of common symptoms of peripheral vestibular disorders.
  4. Symptoms of vertigo and nystagmus lasting from seconds to one minute.
  5. Vertigo that arises from changes in head position related to gravity.
  6. Patients who experienced symptoms for more than three months (chronic patients)
  7. Patients were selected to be ambulant.
  8. Patients suffer from balance disturbance with low risk falling (41-56) and moderate risk falling ranges (21-40) according to berg balance scale.
  9. 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.

Exclusion criteria

Exclusion Criteria:

  1. Benign positional vertigo.
  2. Central vestibular disorders ( Ms, ataxia, migraine headache, posterior inferior cerebellar artery syndrome "PICA").
  3. Vertigo that arises from changes in head position not related to gravity; as vertigo of cervical origin or vascular origin ( Vertebro- basilar insufficiency "VBI").
  4. Previous surgery of the ear.
  5. Bilateral peripheral vestibular weakness, central vestibular weakness, mixed vestibular weakness, or acute vestibular weakness.
  6. Unstable health issues (cardiac dysfunction, end stage renal failure, unstable diabetes, uncontrolled hypertension >190/110...).
  7. Pacemaker or other implanted electrically sensitive device.
  8. Significant orthopedic or chronic pain syndrome (e.g any condition that wouldn't permit to completion of any of the tests).
  9. Major cognitive dysfunction. neurodegenerative disease or major psychiatric condition ( Alzheimer's disease , depression....).
  10. Chronic use of medications that could influence motor or sensory excitability (e.g AEDs, antipsychotic).
  11. Alcohol abuse.
  12. Epilepsy.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Outcomes assessor)
Enrollment
60 participants (estimated)

Study arms

  • Active comparator
    Group A (r TMS group)

    Twenty randomly assigned patients with unilateral 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

  • Active comparator
    Group B (Galvanic stimulation)

    Twenty randomly assigned patients with unilateral peripheral vestibular disorders will undergo galvanic vestibular stimulation; in addition to designed vestibular rehabilitation exercises.

    Device: Galvanic stimulation

  • No intervention
    Control (Group C)

    Twenty randomly assigned patients with unilateral peripheral vestibular disorders will undergo designed vestibular rehabilitation exercises.

Interventions

  • Devicerepetitive transcranial magnetic stimulation

    high frequency (10 HZ) rTMS pulses are applied to the dorsolateral prefrontal cortex of the dominant hemisphere.

  • DeviceGalvanic stimulation

    galvanic stimulation of the vestibular apparatus

06

What researchers measure

Primary outcomes

  1. Vestibular canal weakness

    Videonystagmography- Scores ranging zero min score and 100 max score

    Time frame: 1 mounth

  2. Dizziness handicapped inventory

    identify difficulties that you may be experiencing because of your dizziness- 25 items with max score 100 and min score zero

    Time frame: 1 month

Secondary outcomes

  1. Postural stability

    Computerized dynamic Posturography- Scores ranging zero min score and 100 max score

    Time frame: 1 month

  2. Balance

    Berg balance scale - 14 items each item scored from zero (min score)-4 (Max score) with total min score zero and max score 56

    Time frame: 1 month

  3. Vestibular disorders activities of daily living

    The Vestibular Disorders Activities of Daily Living (VADL) scale assesses the impact of vestibular impairment on everyday activities. The 28 items are grouped into three dimensions: functional (self-care and intimate activities), ambulation (walking and stair climbing), and instrumental (home management and leisure activities).Each item is rated with zero (min score) to 10 (max score)

    Time frame: 1 month

07

Study locations

1 of 1 sites recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Feb 2019 (actual). Primary completion is estimated for Dec 2024, 70 months after the start.

Of 79 non-industry interventional studies with no phase under Vestibular Diseases, half reached primary completion within 16 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 37. This study's planned 70 months is above that.

Counting every sponsor, half of 84 studies reached it within 15 months; a quarter within 8 and three quarters within 34.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 3, 2019
First posted
Jul 8, 2019
StartActual
Feb 1, 2019
Primary completionEst.
Dec 30, 2024
CompletionEst.
Dec 30, 2024
Last update
Feb 14, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 14, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04010435
Lead sponsor
Cairo University
Responsible party
Reham Ali Mohamed Ali Ahmed (Assistant Lecturer, Cairo University) — Principal investigator
First posted
Jul 8, 2019
Start date
Feb 1, 2019
Primary completion
Dec 30, 2024 (estimated)
Completion
Dec 30, 2024 (estimated)
Last update
Feb 14, 2024

Study contacts

Reham A.M. Ahmed, Phd
Contact
rihamelsayed_pt@hotmail.com
00201285059796
Hesham M. S. Nafia, M.Sc
Contact
drhesham101@gmail.com
00201017713483

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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