Ignite Creation Date:
2025-12-24 @ 10:09 PM
Ignite Modification Date:
2026-01-01 @ 9:48 AM
Study NCT ID:
NCT04010435
Status:
RECRUITING
Last Update Posted:
2024-02-14
First Post:
2019-07-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Influence of Central Versus Peripheral Vestibular Stimulation in Patients With Peripheral Vestibular Disorders
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D050781', 'term': 'Transcranial Magnetic Stimulation'}], 'ancestors': [{'id': 'D055909', 'term': 'Magnetic Field Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2024-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-02-12', 'studyFirstSubmitDate': '2019-07-03', 'studyFirstSubmitQcDate': '2019-07-03', 'lastUpdatePostDateStruct': {'date': '2024-02-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-07-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Vestibular canal weakness', 'timeFrame': '1 mounth', 'description': 'Videonystagmography- Scores ranging zero min score and 100 max score'}, {'measure': 'Dizziness handicapped inventory', 'timeFrame': '1 month', 'description': 'identify difficulties that you may be experiencing because of your dizziness- 25 items with max score 100 and min score zero'}], 'secondaryOutcomes': [{'measure': 'Postural stability', 'timeFrame': '1 month', 'description': 'Computerized dynamic Posturography- Scores ranging zero min score and 100 max score'}, {'measure': 'Balance', 'timeFrame': '1 month', 'description': 'Berg balance scale - 14 items each item scored from zero (min score)-4 (Max score) with total min score zero and max score 56'}, {'measure': 'Vestibular disorders activities of daily living', 'timeFrame': '1 month', 'description': '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)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Peripheral Vestibular Disorders']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Definite diagnosis with unilateral peripheral vestibular disorders from audiologist or neurologist.\n2. The patient\'s age will be ranged from thirty to sixty years old.\n3. Patients will experience at least two symptoms of common symptoms of peripheral vestibular disorders.\n4. Symptoms of vertigo and nystagmus lasting from seconds to one minute.\n5. Vertigo that arises from changes in head position related to gravity.\n6. Patients who experienced symptoms for more than three months (chronic patients)\n7. Patients were selected to be ambulant.\n8. Patients suffer from balance disturbance with low risk falling (41-56) and moderate risk falling ranges (21-40) according to berg balance scale.\n9. 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.\n\nExclusion Criteria:\n\n1. Benign positional vertigo.\n2. Central vestibular disorders ( Ms, ataxia, migraine headache, posterior inferior cerebellar artery syndrome "PICA").\n3. Vertigo that arises from changes in head position not related to gravity; as vertigo of cervical origin or vascular origin ( Vertebro- basilar insufficiency "VBI").\n4. Previous surgery of the ear.\n5. Bilateral peripheral vestibular weakness, central vestibular weakness, mixed vestibular weakness, or acute vestibular weakness.\n6. Unstable health issues (cardiac dysfunction, end stage renal failure, unstable diabetes, uncontrolled hypertension \\>190/110…).\n7. Pacemaker or other implanted electrically sensitive device.\n8. Significant orthopedic or chronic pain syndrome (e.g any condition that wouldn\'t permit to completion of any of the tests).\n9. Major cognitive dysfunction. neurodegenerative disease or major psychiatric condition ( Alzheimer\'s disease , depression….).\n10. Chronic use of medications that could influence motor or sensory excitability (e.g AEDs, antipsychotic).\n11. Alcohol abuse.\n12. Epilepsy.'}, 'identificationModule': {'nctId': 'NCT04010435', 'briefTitle': 'Influence of Central Versus Peripheral Vestibular Stimulation in Patients With Peripheral Vestibular Disorders', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Influence of Central Versus Peripheral Vestibular Stimulation on Recovery Outcomes in Patients With Peripheral Vestibular Disorders', 'orgStudyIdInfo': {'id': 'P.T.REC/012/002202'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group A (r TMS group)', 'description': '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.', 'interventionNames': ['Device: repetitive transcranial magnetic stimulation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group B (Galvanic stimulation)', 'description': 'Twenty randomly assigned patients with unilateral peripheral vestibular disorders will undergo galvanic vestibular stimulation; in addition to designed vestibular rehabilitation exercises.', 'interventionNames': ['Device: Galvanic stimulation']}, {'type': 'NO_INTERVENTION', 'label': 'Control (Group C)', 'description': 'Twenty randomly assigned patients with unilateral peripheral vestibular disorders will undergo designed vestibular rehabilitation exercises.'}], 'interventions': [{'name': 'repetitive transcranial magnetic stimulation', 'type': 'DEVICE', 'description': 'high frequency (10 HZ) rTMS pulses are applied to the dorsolateral prefrontal cortex of the dominant hemisphere.', 'armGroupLabels': ['Group A (r TMS group)']}, {'name': 'Galvanic stimulation', 'type': 'DEVICE', 'description': 'galvanic stimulation of the vestibular apparatus', 'armGroupLabels': ['Group B (Galvanic stimulation)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '12613', 'city': 'Cairo', 'state': 'Giza Governorate', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Reham A.M. Ahmed, phd', 'role': 'CONTACT', 'email': 'rihamelsayed_pt@hotmail.com', 'phone': '00201285059796'}], 'facility': 'Cairo university'}], 'centralContacts': [{'name': 'Reham A.M. Ahmed, Phd', 'role': 'CONTACT', 'email': 'rihamelsayed_pt@hotmail.com', 'phone': '00201285059796'}, {'name': 'Hesham M. S. Nafia, M.Sc', 'role': 'CONTACT', 'email': 'drhesham101@gmail.com', 'phone': '00201017713483'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Lecturer', 'investigatorFullName': 'Reham Ali Mohamed Ali Ahmed', 'investigatorAffiliation': 'Cairo University'}}}}