[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"vestibular-diseases\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:vestibular-diseases":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,7,0,[8,46,88,123,140,160,198],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100423276","virtual-reality-in-children-with-and-without-vestibular-deficits-100423276",false,"NCT04791748","Virtual Reality in Children With and Without Vestibular Deficits","Validation and Comparison of a Virtual Reality Protocol in Children Without Vestibular Pathology and Children With Chronic Vestibular déficits : Prospective Study ReViCHILD","ReViCHILD","Inclusion Criteria:\n\n* Minors aged 7 to 17 years (inclusive)\n* Volunteers adult\n* Information and consent of holders of parental authority of minors, minors and of adult subjects\n\nPatients :\n\n* Presence of unilateral or bilateral chronic vestibular pathology\n* Minor patients followed in consultation at Necker Hospital in the Pediatric ENT department\n* Adult patients followed at adult vestibulometry services (Lariboisière and Pitié Salpêtrière Hospitals)\n\nControls:\n\n* No history of otological surgery and absence of vestibular pathology\n* Patients followed in consultation at Necker Hospital, siblings or adult parents\n\nExclusion Criteria:\n\n* Presence of an ophthalmological pathology (including refractive errors)\n* Presence of neurological pathology including epilepsy or any pathology that can alter mobility and interfere with the performance of tasks","ALL","7 Years",{"count":20,"type":21},140,"ESTIMATED","INTERVENTIONAL",[24],"NA","Vestibular information is important in establishing a child's static and dynamic postural control. Any vestibular deficit can have major consequences on development, spatial cognition and quality of life.\n\nIn order to interact with the world around us, we must simultaneously integrate different sources of sensory informations (vision, hearing, perception of the body...). The brain integrates these different sensory components to form a unified and coherent perception: this is multisensory integration.\n\nMultisensory integration has been studied using virtual reality in adults, in the \"spatial orientation\" team of the Center for Integrative Neurosciences and Cognition. These experiments were carried out on healthy subjects and in weightless situations (international space station or parabolic flight). However, no protocol has been developed in children or in subjects with vestibular deficit. Virtual reality is interesting for developing such a protocol because it creates multisensory stimulation capable of promoting visual and proprioceptive compensation of the vestibular deficit.\n\nIt induces an immersion of the patient in a virtual spatial and temporal environment difficult to carry out with traditional vestibular rehabilitation techniques. Its main advantage is that it is a fun and safe interactive diagnostic and therapeutic tool, which is particularly suitable for children. Being able to modulate certain sensory information using virtual reality, in children without vestibular function deficit and in children with vestibular function deficit, will make it possible to better understand the role of the vestibule in the construction of the self in relation to space and environment. In addition to the scientific aspect, the diagnostic and therapeutic benefits are potentially numerous.\n\nThe objective of the study is to determine a reliable, well-tolerated and age-appropriate virtual reality protocol in children without vestibular deficit and in children with chronic vestibular deficit, making it possible to study the hand-eye coordination.",[27],"Vestibular Diseases",[29,30,31,32],"Chronic vestibular deficit in children","Virtual reality protocol","Multisensory integration","Hand-eye coordination","RECRUITING","2026-03-30",{"date":36,"type":37},"2026-04-03","ACTUAL",{"date":39,"type":37},"2021-04-12",{"date":41,"type":21},"2027-02",{"name":43,"class":44},"Assistance Publique - Hôpitaux de Paris","OTHER",1,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":17,"minAge":52,"maxAge":53,"enrollmentInfo":54,"targetDuration":4,"studyType":22,"phases":56,"briefSummary":57,"conditions":58,"keywords":67,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":45},"100554583","long-term-outcomes-after-vestibular-implantation-100554583","NCT06500975","Long Term Outcomes After Vestibular Implantation","Inclusion Criteria\n\n* Adults older than 22 years old who\n* have previously been enrolled in Johns Hopkins University Institutional Review Board protocol NA\\_00051349, IRB00335294 or IRB00346924 and\n* have previously been implanted with a vestibular implant under FDA IDE G150198","22 Years","90 Years",{"count":55,"type":21},32,[24],"Although cochlear implants can restore hearing to individuals who have lost cochlear hair cell function, there is no widely available, adequately effective treatment for individuals suffering chronic imbalance, postural instability and unsteady vision due to bilateral vestibular hypofunction. Prior research focused on ototoxic cases has demonstrated that electrical stimulation of the vestibular nerve via a chronically implanted multichannel vestibular implant can partially restore vestibular reflexes that normally maintain steady posture and vision; improve performance on objective measures of postural stability and gait; and improve patient-reported disability and health-related quality of life. This single-arm open-label study extends that research to evaluate outcomes for up to 8 individuals with non-ototoxic bilateral vestibular hypofunction, yielding a total of fifteen adults (age 22-90 years at time of enrollment) divided as equally as possible between ototoxic and non-ototoxic cases.",[59,60,61,62,63,27,64,65,66],"Bilateral Vestibular Hypofunction","Bilateral Vestibular Deficiency","Bilateral Vestibulopathy","Gentamicin Ototoxicity","Aminoglycoside Toxicity","Sensation Disorders","Labyrinth Diseases","Other Disorders of Vestibular Function",[68,69,70,71,72,73,74,75,76,77,78],"Vestibular","Implant","Prosthesis","Labyrinth","Ototoxicity","Gentamicin","Oscillopsia","Disequilibrium","Dizziness","Vestibulopathy","Inner Ear","2026-03-05",{"date":81,"type":37},"2026-03-09",{"date":83,"type":37},"2024-12-01",{"date":85,"type":21},"2029-12",{"name":87,"class":44},"Johns Hopkins University",{"id":89,"slug":90,"hasResults":11,"nctId":91,"briefTitle":92,"officialTitle":92,"acronym":4,"eligibilityCriteria":93,"healthyVolunteers":11,"sex":17,"minAge":94,"maxAge":53,"enrollmentInfo":95,"targetDuration":4,"studyType":22,"phases":97,"briefSummary":98,"conditions":99,"keywords":104,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":115,"lastUpdatePostDateStruct":116,"startDateStruct":118,"completionDateStruct":120,"leadSponsor":122,"locationsCount":45},"100491270","vestibular-implantation-in-older-adults-100491270","NCT05676944","Vestibular Implantation in Older Adults","Inclusion Criteria:\n\n1. Adults age 65-90 years diagnosed with ototoxic, idiopathic or non-ototoxic\u002Fnon-central bilateral vestibular hypofunction inadequately responsive to vestibular rehabilitation for greater than 1 year as determined by pre-inclusion history, vestibular testing and clinical examination conducted by a board-certified neurotologist, neurologist or other physician skilled in diagnosis of vestibular disorders\n2. Hearing status: (1) Hearing in the candidate ear for implantation is equivalent to or worse than that in the contralateral ear; and (2) hearing in the contralateral ear is good enough to allow functional communication in case hearing in the implanted ear is lost after implantation. Specifically, the contralateral ear must satisfy all of the following criteria:\n\n   1. 0.5\u002F1\u002F2\u002F4 kHz pure-tone-average threshold (PTA) hearing better than (i.e., less than) 70 dB HL; and\n   2. ear-specific sentence recognition score using the recorded AzBio Sentence Test presented at 60 dB SPL-A in quiet must be \\>60% when tested under either the unaided condition or, if 0.5\u002F1\u002F2\u002F4 kHz PTA\\>50 dB, the best-aided condition; and\n   3. ear-specific word recognition score using the recorded Consonant-Nucleus-Consonant (CNC) Word Recognition Test presented at 60 dBHL in quiet must be \\>60% when tested under either the unaided condition or, if 0.5\u002F1\u002F2\u002F4 kHz PTA\\>50 dB, the best-aided condition\n3. Caloric responses consistent with severe or profound bilateral loss of labyrinthine function, as indicated by one or more of the following: (a) summed speed of caloric responses to warm and cool supine caloric stimuli totaling \\\u003C10°\u002Fsec per ear for each of both ears; (b) summed speed of ice water caloric responses during supine and prone head orientation tests totaling \\\u003C10°\u002Fsec per ear for each of both ears; or (c) speed of ice water caloric responses during supine head orientation tests \\\u003C5°\u002Fsec per ear for each of both ears, with a lack of nystagmus reversal on quickly flipping from supine to prone\n4. Prior MRI imaging of the brain, internal auditory canals and cerebellopontine (CP) angle showing a patent labyrinth, present vestibular nerve, patent cochlea, present cochlear nerve, and absence of internal auditory canal\u002Fcerebellopontine angle tumors or other central causes of vestibulo-ocular reflex dysfunction or sensorineural hearing loss\n5. Prior CT imaging of the temporal bones showing a facial nerve canal with normal caliber and course, middle ear without evidence of chronic otitis media or tympani membrane perforation or cholesteatoma, a mastoid cavity with adequate aeration for surgical access to each semicircular canal, skull thickness ≥3 mm at the planned well site, and scalp soft tissue thickness ≤7 mm. This criterion may be satisfied without additional imaging if an existing head CT or MRI already demonstrates those findings\n6. Vaccinations as recommended per Johns Hopkins Cochlear Implant Center and United States Centers for Disease Control and Prevention protocols to reduce the risk of meningitis in subjects undergoing cochlear implantation, as described at this site: https:\u002F\u002Fwww.cdc.gov\u002Fvaccines\u002Fvpd\u002Fmening\u002Fpublic\u002Fdis-cochlear-faq-gen.html\n7. Motivated to travel to the study center, to undergo testing and examinations required for the investigational study, and to participate actively in a vestibular rehabilitation exercise regimen\n8. The participant must agree not to swim or to use or operate vehicles, heavy machinery, powered tools or other devices that could pose a threat to the participant, to others, or to property throughout the duration of participation in the study and until at least 1 month after final deactivation of the MVI Implant\n\nExclusion Criteria:\n\n1. Inability to understand the procedures and the potential risks involved as determined by study staff\n2. Inability to participate in study procedures due to blindness, ≤ ±10° neck range of motion, cervical spine instability, ear canal stenosis or malformation sufficient to prevent caloric testing\n3. Diagnosis of acoustic neuroma\u002Fvestibular schwannoma, chronic middle ear disease, cholesteatoma, or central nervous system causes of vestibulo-ocular reflex dysfunction, including chronic and continuing use of medications, drugs or alcohol at doses sufficiently great to interfere with vestibular compensation\n4. Vestibular dysfunction known to be caused by reasons other than labyrinthine injury due to ototoxicity, ischemia, trauma, infection, Meniere's disease, or genetic defects known to act on hair cells\n5. Lack of labyrinth patency or vestibular nerve as determined by MRI of the brain with attention to the internal acoustic meatus\n6. Any contraindication to the planned surgery, anesthesia, device activation and deactivation, or participation in study assessments, as determined by the surgeon, anesthesiologist, or designee, including known intolerance of any materials used in any component of the investigational devices that will come in contact with the subject\n7. History of myocardial infarction, coronary bypass surgery, or any percutaneous coronary intervention (PCI) within 6 months prior to screening\n8. Orthopedic, neurologic or other nonvestibular pathologic conditions of sufficient severity to confound posture and gait testing or other tests used in the study to assay vestibular function.\n9. Subjects with estimated glomerular filtration rate (GFR) \\\u003C 30 ml\u002Fmin (MDRD formula) at screening\n10. Subjects with heart failure NYHA class III or IV\n11. Subjects with Child-Pugh class C cirrhosis\n12. Inadequately treated or unstable depression, suicidality as indicated by any affirmative answer to the 6-question screener version of the Columbia Suicide Severity Rating Scale (C-SSRS), or any other psychiatric disease or substance abuse history likely to interfere with protocol compliance\n13. Contraindications to scleral coil eye movement testing, including monocular blindness and a history of fainting vagal reactions to prior eye manipulations would exclude subjects from eye coil testing\n14. Inability to tolerate baseline testing protocols\n15. Recent corneal injury\n16. A history of cervical spine disease preventing head rotation\n17. A history of fainting or vagal reactions prior to eye manipulations that would preclude 3D eye movement coil testing\n18. Pregnancy, positive urine or serum pregnancy test at any time during study participation,\n19. Ability to become pregnant combined with failure or refusal to consistently use a highly effective method of contraception from at least 1 month prior to implantation to not before 1 month after both device deactivation and conclusion of study participation. Highly effective contraception methods include:\n\n    Total abstinence. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post ovulation methods) and withdrawal are not acceptable methods of contraception for purposes of defining exclusion criteria for this study Female sterilization (surgical bilateral oophorectomy with or without hysterectomy) or tubal ligation at least six weeks before entering the study. A woman who has undergone oophorectomy without hysterectomy may participate in the study only after her reproductive status has been confirmed by subsequent hormone level assessment For female subjects of child-bearing potential, study participation is not excluded if the study candidate's male partner is the sole partner of the study candidate and has been vasectomized.\n\n    Combination of any two of the following:\n\n    Use of oral, injected or implanted hormonal methods of contraception or other forms of hormonal contraception that have comparable efficacy (failure rate \\\u003C1%), for example, hormone vaginal ring or transdermal hormone contraception Placement of an intrauterine device (IUD) or intrauterine system (IUS) Barrier methods of contraception: Condom or Occlusive cap (diaphragm or cervical\u002Fvault caps) with spermicidal foam\u002Fgel\u002Ffilm\u002Fcream\u002Fvaginal suppository In case of use of oral contraception, women should have been stabile on the same pill for a minimum of 3 months before taking study treatment.\n20. Women who are nursing\u002Flactating\n21. Any medical condition, judged by the investigator team, that is likely to interfere with a study candidate's participation in the study or likely to cause serious adverse events during the study.","65 Years",{"count":96,"type":21},15,[24],"Although cochlear implants can restore hearing to individuals who have lost cochlear hair cell function, there is no widely available, adequately effective treatment for individuals suffering chronic imbalance, postural instability and unsteady vision due to bilateral vestibular hypofunction. Prior research has demonstrated that electrical stimulation of the vestibular nerve via a chronically implanted multichannel vestibular implant can partially restore vestibular reflexes that normally maintain steady posture and vision; improve performance on objective measures of postural stability and gait; and improve patient-reported disability and health-related quality of life. This single-arm open-label study extends that research to evaluate outcomes for up to fifteen older adults (age 65-90 years at time of enrollment) with ototoxic or non-ototoxic bilateral vestibular hypofunction.",[100,101,62,65,27,64,59,61,102,103],"Other Disorders of Vestibular Function, Bilateral","Bilateral Vestibular Deficiency (BVD)","Presbyvestibulopathy","Aminoglycoside Ototoxicity",[68,105,106,107,108,109,110,111,112,113,114],"implant","prosthesis","labyrinth","ototoxicity","gentamicin","oscillopsia","disequilibrium","dizziness","vestibulopathy","inner ear","2026-01-09",{"date":117,"type":37},"2026-01-12",{"date":119,"type":37},"2023-04-11",{"date":121,"type":21},"2028-01-31",{"name":87,"class":44},{"id":124,"slug":125,"hasResults":11,"nctId":126,"briefTitle":127,"officialTitle":127,"acronym":4,"eligibilityCriteria":128,"healthyVolunteers":11,"sex":17,"minAge":52,"maxAge":53,"enrollmentInfo":129,"targetDuration":4,"studyType":22,"phases":131,"briefSummary":57,"conditions":132,"keywords":133,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":115,"lastUpdatePostDateStruct":134,"startDateStruct":135,"completionDateStruct":137,"leadSponsor":139,"locationsCount":45},"100491104","vestibular-implantation-to-treat-adult-onset-bilateral-vestibular-hypofunction-100491104","NCT05674786","Vestibular Implantation to Treat Adult-Onset Bilateral Vestibular Hypofunction","Inclusion Criteria:\n\n1. Adults age 22-90 years diagnosed with ototoxic, idiopathic or non-ototoxic\u002Fnon-central bilateral vestibular hypofunction inadequately responsive to vestibular rehabilitation for greater than 1 year as determined by pre-inclusion history, vestibular testing and clinical examination conducted by a board-certified neurotologist, neurologist or other physician skilled in diagnosis of vestibular disorders\n2. Hearing status: (1) Hearing in the candidate ear for implantation is equivalent to or worse than that in the contralateral ear; and (2) hearing in the contralateral ear is good enough to allow functional communication in case hearing in the implanted ear is lost after implantation. Specifically, the contralateral ear must satisfy all of the following criteria:\n\n   1. 0.5\u002F1\u002F2\u002F4 kHz pure-tone-average threshold (PTA) hearing better than (i.e., less than) 70 dB HL; and\n   2. ear-specific sentence recognition score using the recorded AzBio Sentence Test presented at 60 dB SPL-A in quiet must be \\>60% when tested under either the unaided condition or, if 0.5\u002F1\u002F2\u002F4 kHz PTA\\>50 dB, the best-aided condition; and\n   3. ear-specific word recognition score using the recorded Consonant-Nucleus-Consonant (CNC) Word Recognition Test presented at 60 dBHL in quiet must be \\>60% when tested under either the unaided condition or, if 0.5\u002F1\u002F2\u002F4 kHz PTA\\>50 dB, the best-aided condition\n3. Caloric responses consistent with severe or profound bilateral loss of labyrinthine function, as indicated by one or more of the following: (a) summed speed of caloric responses to warm and cool supine caloric stimuli totaling \\\u003C10°\u002Fsec per ear for each of both ears; (b) summed speed of ice water caloric responses during supine and prone head orientation tests totaling \\\u003C10°\u002Fsec per ear for each of both ears; or (c) speed of ice water caloric responses during supine head orientation tests \\\u003C5°\u002Fsec per ear for each of both ears, with a lack of nystagmus reversal on quickly flipping from supine to prone\n4. Prior MRI imaging of the brain, internal auditory canals and cerebellopontine (CP) angle showing a patent labyrinth, present vestibular nerve, patent cochlea, present cochlear nerve, and absence of internal auditory canal\u002Fcerebellopontine angle tumors or other central causes of vestibulo-ocular reflex dysfunction or sensorineural hearing loss\n5. Prior CT imaging of the temporal bones showing a facial nerve canal with normal caliber and course, middle ear without evidence of chronic otitis media or tympani membrane perforation or cholesteatoma, a mastoid cavity with adequate aeration for surgical access to each semicircular canal, skull thickness ≥3 mm at the planned well site, and scalp soft tissue thickness ≤7 mm. This criterion may be satisfied without additional imaging if an existing head CT or MRI already demonstrates those findings\n6. Vaccinations as recommended per Johns Hopkins Cochlear Implant Center and United States Centers for Disease Control and Prevention protocols to reduce the risk of meningitis in subjects undergoing cochlear implantation, as described at this site: https:\u002F\u002Fwww.cdc.gov\u002Fvaccines\u002Fvpd\u002Fmening\u002Fpublic\u002Fdis-cochlear-faq-gen.html\n7. Motivated to travel to the study center, to undergo testing and examinations required for the investigational study, and to participate actively in a vestibular rehabilitation exercise regimen\n8. The participant must agree not to swim or to use or operate vehicles, heavy machinery, powered tools or other devices that could pose a threat to the participant, to others, or to property throughout the duration of participation in the study and until at least 1 month after final deactivation of the MVI Implant\n\nExclusion Criteria:\n\n1. Inability to understand the procedures and the potential risks involved as determined by study staff\n2. Inability to participate in study procedures due to blindness, ≤ ±10° neck range of motion, cervical spine instability, ear canal stenosis or malformation sufficient to prevent caloric testing\n3. Diagnosis of acoustic neuroma\u002Fvestibular schwannoma, chronic middle ear disease, cholesteatoma, or central nervous system causes of vestibulo-ocular reflex dysfunction, including chronic and continuing use of medications, drugs or alcohol at doses sufficiently great to interfere with vestibular compensation\n4. Vestibular dysfunction known to be caused by reasons other than labyrinthine injury due to ototoxicity, ischemia, trauma, infection, Meniere's disease, or genetic defects known to act on hair cells\n5. Lack of labyrinth patency or vestibular nerve as determined by MRI of the brain with attention to the internal acoustic meatus\n6. Any contraindication to the planned surgery, anesthesia, device activation and deactivation, or participation in study assessments, as determined by the surgeon, anesthesiologist, or designee, including known intolerance of any materials used in any component of the investigational devices that will come in contact with the subject\n7. History of myocardial infarction, coronary bypass surgery, or any percutaneous coronary intervention (PCI) within 6 months prior to screening\n8. Orthopedic, neurologic or other nonvestibular pathologic conditions of sufficient severity to confound posture and gait testing or other tests used in the study to assay vestibular function.\n9. Subjects with estimated glomerular filtration rate (GFR) \\\u003C 30 ml\u002Fmin (MDRD formula) at screening\n10. Subjects with heart failure NYHA class III or IV\n11. Subjects with Child-Pugh class C cirrhosis\n12. Inadequately treated or unstable depression, suicidality as indicated by any affirmative answer to the 6-question screener version of the Columbia Suicide Severity Rating Scale (C-SSRS), or any other psychiatric disease or substance abuse history likely to interfere with protocol compliance\n13. Contraindications to scleral coil eye movement testing, including monocular blindness and a history of fainting vagal reactions to prior eye manipulations would exclude subjects from eye coil testing\n14. Inability to tolerate baseline testing protocols\n15. Recent corneal injury\n16. A history of cervical spine disease preventing head rotation\n17. A history of fainting or vagal reactions prior to eye manipulations that would preclude 3D eye movement coil testing\n18. Pregnancy, positive urine or serum pregnancy test at any time during study participation,\n19. Ability to become pregnant combined with failure or refusal to consistently use a highly effective method of contraception from at least 1 month prior to implantation to not before 1 month after both device deactivation and conclusion of study participation. Highly effective contraception methods include:\n\n    Total abstinence. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post ovulation methods) and withdrawal are not acceptable methods of contraception for purposes of defining exclusion criteria for this study Female sterilization (surgical bilateral oophorectomy with or without hysterectomy) or tubal ligation at least six weeks before entering the study. A woman who has undergone oophorectomy without hysterectomy may participate in the study only after her reproductive status has been confirmed by subsequent hormone level assessment For female subjects of child-bearing potential, study participation is not excluded if the study candidate's male partner is the sole partner of the study candidate and has been vasectomized.\n\n    Combination of any two of the following:\n\n    Use of oral, injected or implanted hormonal methods of contraception or other forms of hormonal contraception that have comparable efficacy (failure rate \\\u003C1%), for example, hormone vaginal ring or transdermal hormone contraception Placement of an intrauterine device (IUD) or intrauterine system (IUS) Barrier methods of contraception: Condom or Occlusive cap (diaphragm or cervical\u002Fvault caps) with spermicidal foam\u002Fgel\u002Ffilm\u002Fcream\u002Fvaginal suppository In case of use of oral contraception, women should have been stabile on the same pill for a minimum of 3 months before taking study treatment.\n20. Women who are nursing\u002Flactating\n21. Any medical condition, judged by the investigator team, that is likely to interfere with a study candidate's participation in the study or likely to cause serious adverse events during the study.",{"count":130,"type":21},8,[24],[100,101,62,65,27,64,59,61,103],[68,105,106,107,108,109,110,111,112,113,114],{"date":117,"type":37},{"date":136,"type":37},"2023-02-28",{"date":138,"type":21},"2027-03-31",{"name":87,"class":44},{"id":141,"slug":142,"hasResults":11,"nctId":143,"briefTitle":144,"officialTitle":144,"acronym":4,"eligibilityCriteria":145,"healthyVolunteers":11,"sex":17,"minAge":146,"maxAge":4,"enrollmentInfo":147,"targetDuration":4,"studyType":22,"phases":149,"briefSummary":150,"conditions":151,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":115,"lastUpdatePostDateStruct":154,"startDateStruct":155,"completionDateStruct":157,"leadSponsor":159,"locationsCount":45},"100347149","vestibular-therapy-in-alzheimers-disease-100347149","NCT03799991","Vestibular Therapy in Alzheimer's Disease","Inclusion Criteria:\n\n* Diagnosis of AD based on the National Institute on Aging-Alzheimer Association 2011 criteria that is mild-moderate (CDR=0.5-2).\n* Age ≥ 60 years.\n* Vestibular loss defined as bilaterally impaired vestibular responses (semicircular canal or otolith responses).\n* Able to participate in study procedures including vestibular physiologic testing, balance and gait assessment, neurocognitive testing, and VT or active control.\n* Able to give informed consent, as further detailed in the Human Subjects section. The investigators anticipate that individuals who are too impaired to provide informed consent would also not be able to effectively participate in VT or active control.\n* Presence of a caregiver, defined as an individual who spends at least 10 hours per week with the patient. The caregiver must be able to participate in study procedures, specifically the text-messaging system. Both the VT and active control involve 8 weeks of once weekly visits and daily home exercises, and the investigators believe a caregiver would increase the likelihood of successful completion of either therapy.\n\nExclusion Criteria:\n\n* Diagnosis of severe AD (CDR≥3).\n* Diagnosis of mild cognitive impairment or diagnosis of non-AD dementia, for example Parkinson's disease dementia, Dementia with Lewy Bodies, vascular dementia, fronto-temporal dementia, and primary progressive aphasia.\n* Deemed unable to participate in study procedures and VT or active control, (e.g. patients with significant medical comorbidities, excessive agitation, or use of mobility aids such as a cane or walker.)\n* Use of daily vestibular suppressant medications, specifically anti-histamines and benzodiazepines, as this can alter the response to VT.\n* Lack of availability to participate in 8 weeks of VT or active control.","60 Years",{"count":148,"type":21},100,[24],"Nearly 2 out of 3 patients with Alzheimer's disease (AD) experience problems with balance and mobility, which places such patients at increased risk of falling. The vestibular (inner ear balance) system plays an important role in balance stability, and vestibular therapy (VT) is well-known to improve balance function in healthy older adults. In this study, the investigators will conduct a first-in-kind randomized clinical trial to evaluate whether vestibular therapy improves reduces falls in patients with AD, in whom this treatment has never been studied.",[27,152,153],"Vestibular Disorder","Alzheimer Disease",{"date":117,"type":37},{"date":156,"type":37},"2022-08-22",{"date":158,"type":21},"2027-08-26",{"name":87,"class":44},{"id":161,"slug":162,"hasResults":11,"nctId":163,"briefTitle":164,"officialTitle":164,"acronym":165,"eligibilityCriteria":166,"healthyVolunteers":11,"sex":17,"minAge":167,"maxAge":168,"enrollmentInfo":169,"targetDuration":4,"studyType":22,"phases":171,"briefSummary":172,"conditions":173,"keywords":177,"overallStatus":187,"whyStopped":4,"lastUpdateSubmitDate":188,"lastUpdatePostDateStruct":189,"startDateStruct":191,"completionDateStruct":193,"leadSponsor":195,"locationsCount":197},"100557134","telerehabilitation-of-balance-clinical-and-economic-decision-support-system-100557134","NCT06534164","Telerehabilitation of Balance Clinical and Economic Decision Support System","TeleRehab DSS","ALL PARTICIPANT Inclusion Criteria:\n\n* Age 40-80 years\n* community dwelling able to walk 500-m independently or with a stick\n* Depression subscale on Hospital Anxiety and Depression Scale \\\u003C10\u002F21 (14-item questionnaire)\n* No significant visual impairment (as self-reported by participants)\n* Willing to comply with study procedures, proposed training and testing regime\n* With capacity to consent\n* No acute musculoskeletal or other injuries that would prevent participation in a structured exercise program\n* Is not currently, and has not in the past 8-weeks received any falls\u002Fbalance\u002Fvestibular and\u002For cognitive rehabilitation.\n* Does not any implanted medical devices or a cardiac pacemaker.\n* Does not have any other co-existing neurological conditions (ie. Multiple sclerosis, Parkinson's disease, neuropathy etc.)\n* Does not have any language or communication deficits impairing their ability to communicate and\u002For express their thoughts.\n* Has at least one functional hand for grip function and computer use.\n* Fulfilling all of the criteria from one of the below sub-groups\n\nSTROKE COHORT who will fulfil the additional criteria:\n\n* Individuals with diagnosis of focal ischaemic or haemorrhagic stroke, as confirmed by a clinical letter.\n* Onset \\>\u002F= 3 months prior to study.\n* Montreal Cognitive Assessment (MoCA) score n \\>\u002F=23\n* At risk of falls (i.e. Functional Gait Assessment FGA score \\\u003C\u002F=22\u002F30; FGA is a validated quick balance task assessment) AND\u002FOR having experienced a fall(s) in the last 12 months\n\nMCI COHORT who will fulfil the additional criteria:\n\n* Individuals with new or existing formal diagnosis of MCI, according to the International Classification of Disease 10 (ICD10) , as confirmed by a clinical letter.\n* At risk of falls (FGA \\\u003C\u002F= 22\u002F30) AND\u002FOR having experienced a fall(s) in the last 12 months.\n\nVESTIBULAR COHORT who will fulfill the additional criteria\n\n* Montreal Cognitive Assessment (MoCA) score n \\>\u002F=23\n* Individuals with a diagnosis of a vestibular disorder (peripheral and\u002For mixed peripheral and central):\n* Peripheral vestibular disorder in which the balance problem lies in the vestibular\u002Fbalance system within the inner ear.\n* Mixed vestibular disorder in which the balance problem lies in the vestibular\u002Fbalance system within the inner ear (peripheral) and involving the nerves or neuronal network in the brain\u002Fbrainstem responsible for balance (central).\n* Chronic dizziness and\u002For unsteadiness (\\>\u002F= 3 months duration) that started at the time or after the vestibular disorder diagnosis.\n* Dizziness handicap inventory (DHI \\>34) AND\u002FOR At risk of falls (FGA \\\u003C\u002F=22\u002F30)\n\nLONG COVID-19 COHORT who will fulfill the additional criteria:\n\n* Montreal Cognitive Assessment (MoCA) score n \\>\u002F=23\n* Individuals with laboratory confirmed diagnosis of Covid (\\>\u002F=6 months prior to study onset), as confirmed by a clinical letter.\n* Who have been diagnosed with long Covid, as confirmed by a clinical letter.\n* Who have chronic dizziness and\u002For unsteadiness which started after the Covid illness (self-report by the patient; duration \\\u003C\u002F=3 months).\n* Dizziness handicap inventory (DHI \\>34) AND\u002FOR At risk of falls (FGA \\\u003C\u002F=22\u002F30)\n\nExclusion Criteria:\n\n* Outside of the stated age bracket\n* Unable to walk independently (even with use of a walking stick)\n* MOCA score \\\u003C23\n* Score of 10 or higher on depression subscale of HADS\n* Unwilling to comply with study procedures, proposed training and testing regime\n* No capacity to consent\n* Significant visual impairment or homonymous hemianopia (stroke cohort only) (self-reported)\n* Orthostatic hypotension or uncontrolled hypertension\n* Other neurological problem (e.g. Parkingson's disease, Multiple Sclerosis etc.)\n* Language and communication deficits impairing ability to express thoughts (e.g. Aphasia)\n* Has participated in a clinical drug trial in the past 6 months.\n* Acute musculoskeletal injury that prevents participation in a structured exercise programme (e.g. lower limb fracture).\n* Has an implanted medical device or cardiac pacemaker.\n* Diagnosis of unstable Meniere's or with more than 4 migraines\u002Fmonth at the time of participating in the study\n* Not fulfilling the inclusion criteria for one of the sub-groups (such as criteria for Stroke group, or MCI group, or chronic vestibular disorder group, or long-Covid group), as outlined above.\n* Unable to provide a clinical letter confirming diagnosis.\n* For those with stroke, no visual spatial neglect.","40 Years","80 Years",{"count":170,"type":21},460,[24],"This study follows the successfully completed HOLOBalance project which was funded by the EU Horizon 2020 scheme. TheHOLOBalance platform delivers exercises demonstrated via a hologram of the physiotherapist and corrected in real time by the hologram prompts based on performance monitoring via sensors. Further information is available at: https:\u002F\u002Fholobalance.eu\u002F. HOLOBalance was developed as a comprehensive rehabilitation protocol for individualised remote (tele)rehabilitation balance physiotherapy programme. It includes different multisensory balance and gait exercises, physical activity and memory training and exergames (video games which are also exercises) to improve balance function in older adults. The system can thus assess and remotely monitor how users are performing the exercises.\n\nThis multisite randomised control trial (TeleRehab DSS, short for TeleRehabilitation Decision Support System) aims to (i) determine the system's safety, acceptability, and feasibility explore effectiveness of running such programme in comparison with the current standard care for middle-age\u002Folder adults with balance disorders\u002Ffalls due to MCI, vestibular disorders, stroke or long Covid. This study also aims to (ii) assess if balance function, gait, cognitive function, balance confidence, and wellbeing can improve more compared to standard intervention and (iii) provide preliminary data for a definitive randomised controlled trial.\n\nThis study involves human participants, and each clinical site has applied for appropriate ethical approval.",[174,175,27,176],"Stroke","Mild Cognitive Impairment","Long Covid19",[178,179,180,181,182,183,184,185,186],"vestibular","rehabilitation","falls","balance","exercise","artificial intelligence","telerehabilitation","physiotherapy","cognitive","NOT_YET_RECRUITING","2025-07-03",{"date":190,"type":37},"2025-07-10",{"date":192,"type":21},"2025-09-01",{"date":194,"type":21},"2026-08-31",{"name":196,"class":44},"University College, London",5,{"id":199,"slug":200,"hasResults":11,"nctId":201,"briefTitle":202,"officialTitle":203,"acronym":4,"eligibilityCriteria":204,"healthyVolunteers":11,"sex":17,"minAge":205,"maxAge":4,"enrollmentInfo":206,"targetDuration":208,"studyType":209,"phases":4,"briefSummary":210,"conditions":211,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":213,"lastUpdatePostDateStruct":214,"startDateStruct":216,"completionDateStruct":218,"leadSponsor":220,"locationsCount":45},"100340774","genotype-phenotype-correlation-study-of-presymptomatic-and-symptomatic-dfna9-patients-100340774","NCT03716908","Genotype-phenotype Correlation Study of Presymptomatic and Symptomatic DFNA9 Patients","Evaluation of Hearing and Vestibular Function in Presymptomatic and Symptomatic DFNA9 Patients Carrying the Pro51Ser (P51S) Mutation in the COCH Gene.","Inclusion Criteria:\n\n* subject must be 18 year of older\n* subject is a family member of the family pedigree's proband(s) carrying a P51S COCH mutation\n\nExclusion Criteria:\n\n* subject is younger than 18 years\n* subject is not a family member of the pedigree's proband(s) carrying a P51S\n* subject cannot undergo investigations (medical and\u002For mental reasons)\n* subject is not willing to be enrolled into the study\n* subject suffers other concomitant middle or inner ear disease\n* subject has undergone middle ear or inner ear surgery\n* subject suffers other concomitant vestibular disease than DFNA9\n* subject has undergone vestibular surgery or other non-invasive vestibular treatment (gentamicin intratympanal injections for example)","18 Years",{"count":207,"type":21},70,"1 Year","OBSERVATIONAL","DFNA9 (Deafness Autosomal Dominant 9) is an autosomal dominant hereditary hearing loss which is associated with vestibular deterioration. The most recent genotype-phenotype correlation studies have been conducted more than 15 years ago. Meanwhile, emerging and valuable vestibular tests have been added to the vestibular test battery. These tests were not available at the time of the correlation studies. The aim of this study is to carry out a prospective cross-sectional study on symptomatic and presymptomatic affected carriers of the Pro51Ser (P51S) Coagulation Factor C Homology (COCH) mutation in order to correlate vestibular data using the complete vestibular test battery with the known data on hearing and vestibular function in relation to age.",[27,212],"DFNA9","2021-10-27",{"date":215,"type":37},"2021-10-28",{"date":217,"type":37},"2018-06-01",{"date":219,"type":21},"2026-11-30",{"name":221,"class":44},"Jessa Hospital"]