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rTMS Plus Vestibular Rehabilitation as an Adjunct Treatment for Fall Risk and Postural Instability for Chronic Vestibular Dizziness Patients/ Chronic Labyrinthitis

Sponsor
Beni-Suef University (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT05871385
Collaborator
Cairo University (Other)
50
Enrollment
1
Location
2
Arms
2.3
Anticipated Duration (Months)
22.1
Patients Per Site Per Month

Study Details

Study Description

Brief 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. 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

Condition or Disease Intervention/Treatment Phase
  • Device: rTMS group
  • Device: placebo rTMS group
 N/A

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

Study Type:
Interventional
Actual Enrollment :
50 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
rTMS Plus Vestibular Rehabilitation as an Adjunct Treatment for Fall Risk and Postural Instability for Chronic Vestibular Dizziness Patients, Double Blinded RCT
Actual Study Start Date :
Apr 23, 2023
Anticipated Primary Completion Date :
Jun 1, 2023
Anticipated Study Completion Date :
Jul 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Group A (r TMS group)

Twenty five 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.

Device: rTMS group
Twenty five 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
Other Names:
  • repetitive transcranial magnetic stimulation

    		•
    Placebo Comparator: Control (Group B) (placebo rTMS)

    Twenty five randomly assigned patients with peripheral vestibular disorders will undergo placebo rTMS plus designed vestibular rehabilitation exercises.

    Device: placebo rTMS group
    Twenty five randomly assigned patients with peripheral vestibular disorders will undergo placebo rTMS plus designed vestibular rehabilitation exercises.
    Other Names:
  • placebo rTMS

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Postural stability [change from baseline to 6 weeks after intervention]

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

    Secondary Outcome Measures

    1. Berg balance scale [change from baseline to 6 weeks after intervention]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    40 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. Diagnosis with peripheral vestibular disorders from audiologist or neurologist.

    2. The patient's age will be ranged from forty to sixty five 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:

    1. Central vestibular disorders ( Ms, ataxia, migraine headache, posterior inferior cerebellar artery syndrome "PICA").

    2. Vertigo that arises from changes in head position not related to gravity; as vertigo of cervical origin or vascular origin ( Vertebro- basilar insufficiency "VBI").

    3. Previous surgery of the ear.

    4. Bilateral peripheral vestibular weakness, central vestibular weakness, mixed vestibular weakness, or acute vestibular weakness.

    5. Unstable health issues (cardiac dysfunction, end stage renal failure, unstable diabetes, uncontrolled hypertension >190/110…).

    6. Pacemaker or other implanted electrically sensitive device.

    7. Significant orthopedic or chronic pain syndrome (e.g any condition that wouldn't permit to completion of any of the tests).

    8. Major cognitive dysfunction. neurodegenerative disease or major psychiatric condition ( Alzheimer's disease , depression….).

    9. Chronic use of medications that could influence motor or sensory excitability (e.g AEDs, antipsychotic).

    10. Alcohol abuse.

    11. Epilepsy.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 faculty of medicine , Cairo University Cairo Egypt

    Sponsors and Collaborators

    • Beni-Suef University
    • Cairo University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Ahmed Samir Abdelkhalik Youssef, lecturer at faculty of physical therapy, Beni-Suef University
    ClinicalTrials.gov Identifier:
    NCT05871385
    Other Study ID Numbers:
    • P.T.REC/012/002202
    First Posted:
    May 23, 2023
    Last Update Posted:
    May 23, 2023
    Last Verified:
    May 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Vestibular Diseases
    Dizziness

    Study Results

    No Results Posted as of May 23, 2023