Vestibular Disorder

Researchers are investigating the relationship between functional measures of balance and gait and objective kinetic and kinematic parameters in people with Multiple Sclerosis (MS). This cross-sectional observational study aims to understand how biomechanical gait and balance data collected through the Vicon motion analysis system relate to clinical assessments of balance, gait, and physical performance. The study seeks to identify which biomechanical factors are most closely linked to functional abilities and mobility challenges in MS. Participants will attend a single laboratory session where they will undergo biomechanical analysis of balance and gait using the Vicon motion capture system. They will also complete standardized functional tests including the Mini Balance Evaluation Systems Test, Functional Gait Assessment, Short Physical Performance Battery, and a 2-Minute Walk Test. Additionally, they will fill out questionnaires assessing fear of falling and fatigue and have their lower-limb spasticity evaluated with the modified Ashworth Scale. During the session, which takes about 40 minutes for the primary kinetic and kinematic analysis and additional time for functional assessments, researchers will collect detailed movement data alongside clinical measures. This data will be analyzed to explore correlations between biomechanical parameters and functional outcomes. The study includes assessments of postural control, gait performance, physical endurance, fatigue, and spasticity. The findings aim to improve understanding of movement impairments in MS and support better clinical assessments and rehabilitation approaches.

Researchers are evaluating a low-cost augmented reality platform for balance training in patients with balance disorders caused by degenerative injuries or cerebrovascular diseases. The study aims to determine if the system is usable, acceptable, safe, and if it improves balance. The trial is a usability study conducted by the Hospital Universitari Vall d'Hebron Research Institute. The intervention has two phases: the first phase lasts four weeks with supervised balance training sessions at the hospital, conducted for 60 minutes, three times a week. If patients meet inclusion criteria, the intervention continues for two additional weeks at home with a family member trained to assist as a training partner. The platform uses different exercise protocols accessed through RGSweb, including balance and sit-to-stand exercises with visual targets and movement tracking. Participants undergo three assessments: before treatment (Day 0), after the hospital phase (Week 4), and after the home phase (Week 6). Evaluations include usability scales, adherence measures, balance tests like the Berg Balance Scale, postural sway, sit-to-stand tests, balance confidence, and quality of life questionnaires. Safety is monitored throughout, and adherence is tracked during both hospital and home interventions.

Researchers are evaluating a new approach to care for patients experiencing dizziness in the emergency department (ED). This multi-site feasibility trial compares placing a physical therapist directly in the ED to start care immediately versus the usual care where patients might wait for outpatient therapy. The study aims to assess the ability to enroll patients, deliver the intervention properly, and collect patient outcome data over time. The trial will take place at two hospital EDs, each randomly assigned to either the embedded physical therapy intervention or usual care. The intervention involves a physical therapist providing standard exercises, maneuvers, and coaching directly in the ED during patient visits from 8am to 8pm. Usual care consists of typical ED tests and treatments without physical therapy involvement. A third hospital will contribute baseline data but will not enroll participants. The active intervention phase lasts 9 months, followed by 12 months of ongoing data collection. Participants will be adults 18 years or older who visit the ED with dizziness during the specified hours and speak English or Spanish. Researchers will collect surveys from participants over 12 months to measure dizziness impact and retention rates, along with electronic health record data on therapy adoption, care fidelity, and healthcare use. Clinician feedback on the intervention’s acceptability and feasibility will also be gathered before and after the study period. The total study duration for each participant includes the 9-month intervention and 12-month follow-up.

Researchers are evaluating the safety, tolerability, and effectiveness of the gene therapy SENS-501 in children aged 6 to 31 months who have severe to profound hearing loss caused by mutations in the Otoferlin gene. This open-label Phase I/II study focuses on children with pre-lingual hearing loss due to these genetic mutations, aiming to better understand how this treatment works in this young population. The study involves administering SENS-501 directly into one ear using a special injection system. It includes a dose-escalation phase where children receive either a low or high dose, followed by a dose expansion phase where the dose recommended from earlier phases is given. The treatment is given as a single unilateral intracochlear injection, and the administration system's safety, performance, and usability are also evaluated. Participants will be followed for up to 5 years to monitor safety and tolerability and to assess hearing improvement using auditory brainstem response (ABR) and pure tone audiometry (PTA). Additional evaluations include clinical checks of the administration system shortly after treatment. Throughout the study, children will undergo hearing tests and medical assessments to measure outcomes and track any side effects or complications from the treatment and procedure.

Researchers are evaluating auricular transcutaneous vagus nerve stimulation (aTVNS) as a treatment for chronic dizziness, including Persistent Postural-Perceptual Dizziness (PPPD). The study aims to measure changes in dizziness using the Dizziness Handicap Inventory (DHI) score after a 4-week treatment period. This is a randomized, double-blind trial sponsored by Mayo Clinic that compares active aTVNS with a sham control device. Participants are randomly assigned to one of two groups. The active treatment group will perform two daily sessions of aTVNS, each about 30 minutes, totaling 1 hour per day for 8 weeks. The sham control group will perform two daily sessions using a device that mimics stimulation without electrical current for 4 weeks, then switch to the active treatment for the remaining 4 weeks. The aTVNS device delivers mild electrical pulses to the ear to stimulate the vagus nerve. During the study, participants will complete assessments at baseline, 4 weeks, and 8 weeks. Researchers will measure dizziness changes using the DHI score, anxiety levels, postural sway, and frequency of dizzy days. The study includes monitoring of symptoms and safety throughout the approximately 8-week period. The goal is to understand the effects of aTVNS on dizziness and related symptoms in adults with PPPD.

Researchers are evaluating whether an experimental vestibular implant system can improve balance in adults with bilateral vestibulopathy who have normal to severe hearing loss. The implant system includes a vestibular implant surgically placed behind the ear in the mastoid bone, combined with a cochlear implant sound processor and programming software, designed to preserve hearing in the implanted ear. The study aims to assess safety and performance in restoring balance in this population. Participants will receive the vestibular implant device, which stimulates the vestibular nerve via an electrode. The sound processor worn behind the ear powers the implant. The study includes a baseline pre-surgery phase and a six-month post-implantation follow-up period to evaluate changes in balance and hearing function. The intervention is implanted surgically and assessed over time. During the study, participants will undergo various tests to evaluate balance and hearing, including the Dynamic Gait Index, Functional Gait Assessment, posturography sensory tests, and questionnaires on dizziness, fall risk, and quality of life. Hearing thresholds will also be monitored. Assessments occur from baseline up to six months after activation of the implant. Safety and device-related adverse events will be closely monitored throughout the study.

Researchers are evaluating a combined therapy called Acceptance and Commitment Therapy Integrated Vestibular Rehabilitation (ACTIVE) for individuals aged 18 to 49 who have vestibular symptoms related to mild traumatic brain injury (mTBI). This trial compares ACTIVE with usual care vestibular rehabilitation (VESTIB CONTROL) to see which approach better reduces symptoms and improves recovery. The study focuses on military service members and civilians who experience ongoing dizziness and related impairments after mTBI. Participants in the ACTIVE group will receive four weekly 90-minute sessions combining Acceptance and Commitment Therapy (ACT) and targeted vestibular rehabilitation exercises, along with daily at-home activities over four weeks. The ACT component focuses on psychological flexibility and mindfulness. The comparison group will receive usual care vestibular rehabilitation and other supportive treatments excluding ACT, also delivered weekly over four weeks. Both groups will have individualized care based on their needs. Participants will be assessed before treatment and at 4 weeks, 3 months, and 6 months after treatment ends. Assessments include dizziness severity, anxiety levels, vestibular function tests, symptom questionnaires, and activity monitoring using Fitbit devices. Researchers will monitor symptoms, functional improvements, and return to activity status. The total participation period covers about six months, allowing for evaluation of both short- and longer-term outcomes.

Researchers are studying the accuracy of a new device called the laryngopharyngeal endoscopic esthesiometer and rangefinder (LPEER) to measure throat sensitivity in patients suspected of having obstructive sleep apnea (OSA). This prospective, double-blinded, randomized crossover trial aims to validate this device's measurements by comparing them to standard sleep study results. The study focuses on understanding sensory differences in patients with mild, moderate, and severe OSA and improving knowledge about OSA’s underlying mechanisms. The study involves patients referred for a baseline sleep test who will undergo a sensory test using the LPEER, which delivers air pulses of varying intensity to specific throat areas: the velopharynx, hypopharynx, and aryepiglottic folds. Experienced and less experienced pulmonologists or otolaryngologists will perform these tests to assess measurement reliability. The study design includes randomized crossover assignment of raters to evaluate intra- and inter-rater agreement and diagnostic accuracy through detailed statistical analyses. Participants will attend the sleep laboratory where they will receive the sensory test alongside their routine sleep study. Researchers will measure sensory thresholds at three throat sites and collect data related to sleep apnea severity, oxygen levels, and any adverse events. The study will last up to 15 days for each participant, during which safety and test accuracy will be closely monitored. Results will help determine the usefulness of LPEER for future clinical evaluation and monitoring of OSA patients.

Benign Paroxysmal Positional Vertigo (BPPV) is a common cause of recurrent vertigo that affects about 2.4% of people during their lifetime, especially older adults. It causes brief episodes of vertigo, dizziness, and imbalance that can reduce quality of life. Although maneuvers to reposition the inner ear crystals are effective, BPPV often recurs, so this study is evaluating if adding Brandt-Daroff exercises to the GANS Maneuver can further reduce dizziness and improve quality of life in patients with BPPV. Participants will be randomly assigned to one of two groups: one group will receive the GANS Maneuver alone, while the other will receive the GANS Maneuver combined with Brandt-Daroff exercises. The intervention lasts six weeks, with supervised GANS Maneuver sessions held twice weekly, each including three repetitions. Those in the combined group will also perform Brandt-Daroff exercises at home twice daily. The total supervised GANS sessions will be 12, and the Brandt-Daroff exercises will be done 36 times at home during the study. During the study, dizziness and quality of life will be assessed using the Dizziness Handicap Inventory Scale (DHI) and the Vestibular Activities and Participation (VAP) Scale at the start and after six weeks of treatment. Participants will attend regular supervised sessions for assessment and treatment. Data will be analyzed to see if adding Brandt-Daroff exercises improves outcomes compared to GANS Maneuver alone. The study is conducted over one year with ethical approval and careful monitoring of participants.

Diabetic Peripheral Neuropathy (DPN) is a common problem in people with type 2 diabetes, causing symptoms like pain, numbness, and balance difficulties. These issues can lead to falls, foot ulcers, and lower quality of life. Current treatments mainly focus on symptom management, so this study aims to evaluate if adding Neural Mobilization (NM) to balance training can further improve pain, balance, and quality of life in people with DPN. The trial is a randomized controlled study involving 32 patients aged 50 to 75 years. Participants will be randomly assigned to one of two groups for six weeks: one group will receive Neural Mobilization combined with balance training plus standard care, while the other group will receive balance training alone along with standard care. Each group will have two 30-minute sessions per week. The NM protocol includes hot packs, TENS, nerve sliding and tensioning techniques, and various balance exercises that increase in difficulty over time. The balance training group receives similar physical therapy without the neural mobilization techniques. Throughout the study, participants will undergo assessments at the beginning and end of the six-week treatment period. Researchers will measure pain levels using the Numeric Pain Rating Scale, balance using the Berg Balance Scale, and quality of life with the Norfolk Quality of Life-Diabetic Neuropathy questionnaire. Data will be analyzed to determine if adding Neural Mobilization offers additional benefits. Ethical approval has been obtained, and participants will provide informed consent before joining.