Clinical Research Directory

SMART Concussion Trial: Symptom Management vs Alternative Randomized Treatment of Concussion Trial

Given the rising rates of concussion in youth ages 10-19 and the significant proportion of young people who remain symptomatic for months following concussion, research evaluating the efficacy of multifaceted treatment options following concussion is imperative. Studies examining the efficacy of treatment strategies following concussion in children and adults are surprisingly limited, and most focus on one treatment approach, have small sample sizes, are not randomized controlled trials, and focus on individuals with prolonged recovery (months). There is a need for a multifaceted treatment trial to examine the early implementation of treatment approaches that may reduce prolonged recovery while considering the heterogeneous presentation of symptoms and patient preferences in the sub-acute stage following concussion. Randomized controlled trials that consider a multifaceted transdisciplinary approach to treatment in the early period following concussion are needed to raise the bar regarding evidence-informed management following concussion

Motion Sickness Severity and Sensorimotor Performance

Background: Motion sickness (MS) is a common syndrome characterized by autonomic and behavioral symptoms, such as nausea and dizziness, resulting from exposure to motion stimuli. Its pathophysiology is closely linked to sensory conflict and postural instability theories. While previous studies suggest that postural control, proprioception, and reaction times are affected in individuals susceptible to MS, there is a lack of comprehensive, comparative research evaluating all these parameters concurrently within the same cohort using standardized methods. Objective: This study aims to systematically measure balance, proprioceptive sensitivity, coordination, and reaction time parameters, and quantitatively analyze their relationship with motion sickness severity. Methodology: In this prospective, cross-sectional study, at least 41 participants aged 18-40 with motion sickness will be recruited. Participants will undergo motion sickness susceptibility and severity grading using the Motion Sickness Susceptibility Questionnaire Short Form (MSSQ-SF) and the Graybiel Scale. Objective assessments will include static and dynamic balance testing (ProKin®), knee joint position sense (Clinometer app), manual dexterity and dynamic balance coordination (Nine-Hole Peg Test, Tandem Walk, Romberg Test), and upper/lower extremity reaction time measurements (BlazePod system).

Effects of Wiifit vs Conventional Vestibular Rehabilitation on Dizziness and Balance in Patients With Unilateral Peripheral Vestibular Dysfunction

Unilateral Peripheral Vestibular Dysfunction (UPVD) causes dizziness, imbalance, vertigo, and reduced quality of life. Conventional Vestibular Rehabilitation Therapy (cVRT) is effective, while WiiFit-based virtual reality training may further enhance motivation and neuroplasticity. This study aims to compare WiiFit-based training with conventional rehabilitation in improving balance and reducing dizziness in UPVD patients. A randomized controlled trial will include participants aged 18-65 meeting specific inclusion and exclusion criteria. Participants will be randomly divided into two groups: Group A receiving conventional therapy (40 minutes, 3 sessions/week) and Group B receiving WiiFit-based exercises for 4 weeks. Outcomes will be assessed using DHI, Mini-BESTest, and VADL before and after intervention.

Ai Chi-Based Rehabilitation for Peripheral Unilateral Vestibular Dysfunction

This study aims to evaluate the effects of an Ai Chi-based rehabilitation program on balance, dizziness severity, and quality of life in patients with unilateral peripheral vestibular hypofunction. Participants will be randomly assigned to either a control group receiving standard home-based vestibular rehabilitation exercises or an intervention group receiving additional Ai Chi sessions. The intervention will be conducted over a 4-week period with a total of 10 sessions under the supervision of a certified therapist.

Conventional Vestibular Training Versus Immersive Virtual Reality- Based Vestibular in Multiple Sclerosis

The effectiveness of convectional vestibular training for balance and dizziness rehabilitation in people with multiple sclerosis has been recently demonstrated in a meta-analysis by this research team (doi: 10.3390/jcm9020590). Furthermore, non-immersive virtual reality-based environments seem to be useful for balance and gait rehabilitation in this population (doi: 10.1177/0269215518768084). However, nothing is known about the feasibility and effectiveness of immersive virtual reality-based rehabilitation in people with multiple sclerosis. The primary aim of this research is to determine the feasibility, safety and effectiveness of an immersive virtual reality-based vestibular training for dizziness, balance and fatigue rehabilitation, compared to conventional vestibular training.

Implementation of Evidence-Based Practice for Dizziness

The study evaluates the implementation of evidence-based practice for the management of patients with dizziness in the emergency department (ED) within a large integrated health care system. The clinical focus is on benign paroxysmal positional vertigo (BPPV), unilateral vestibulopathy (e.g., vestibular neuritis), and stroke - which are disorders with established evidence-base practices for evaluation and management. Evidence-based practices for these clinical topics have not properly disseminated regarding dizziness visits, and this results in missed opportunities for effective and efficient care delivery. The investigators propose a hybrid type 3 effectiveness-implementation trial to evaluate an enhanced BPPV-centric implementation strategy and clinical intervention. The overall strategy, initially developed in Dizziness Treatment through Implementation \& Clinical strategy Tactics-1 (DIZZTINCT-1), will be improved to increase generalizability, convenience, exposures, sustainability, and dissemination. We use an innovative design of a stepped-wedge trial for the ED-level implementation strategy and an embedded randomized patient-level dissemination strategy. As a result, we can closely assess the individual and additive impact of study components. We will evaluate effectiveness of the implementation strategy and also confirm clinical outcomes.

Osteopathic Manipulative Treatment vs Physiotherapy in Cervicocranial Dysfunction

This study aims to compare the effects of osteopathic manipulative treatment and standard physiotherapy in patients with cervicocranial dysfunction. The study will evaluate outcomes including dizziness, headache impact, neck disability, and psychological stress. Participants will be randomly assigned to one of two groups: osteopathic treatment or standard physiotherapy. The interventions will be applied over a defined treatment period, and outcomes will be measured before and after the intervention. The purpose of this study is to determine which approach is more effective in improving symptoms and functional outcomes in patients with cervicocranial dysfunction.

Fall Risk Assessment and Speech Intelligibility Enhancement Using In-ear Device

The purpose of this study is to develop and validate methods to use hearing aids equipped with embedded sensors and artificial intelligence to assist in the assessment of fall risk and in the implementation of interventions aimed at reducing the risk of falling, as well as to improve speech intelligibility in quiet and in background noise, track physical activity, and social engagement. The investigators hope is that the knowledge that is generated through this study will ultimately translate to the clinical setting and will help reduce the likelihood that individuals experience a fall, and improve the quality of hearing in individuals who wear hearing aids.

A Multi-Site Feasibility Trial of Embedded Emergency Department Physical Therapy for Dizziness

This is a multi-site feasibility trial of an embedded emergency department (ED) physical therapy care model for dizziness at two EDs in the Northwestern Medicine and University of Utah Health systems. The study intervention (embedded ED physical therapy) is a reconceptualization of the traditional outpatient physical therapy care model in which we place a physical therapist directly in the ED to initiate timely care for patients with dizziness; we previously evaluated this intervention in a single center randomized trial for low back pain. This multi-site feasibility trial will be comprised of 9 months of active intervention and 12 months of longitudinal data collection. The two sites will be parallel randomized 1:1 to receive either the embedded ED physical therapy condition (intervention, n=1) or usual care (control, n=1) via simple randomization. This trial focuses on feasibility outcomes - such as our ability to enroll participants, deliver the intervention with fidelity, and collect longitudinal patient-reported outcome data and electronic health record data.

Efficacy and Safety of Rimegepant for Acute Dizziness

This study aims to explore the efficacy and safety of rimegepant for acute dizziness, including vestibular migraine (VM) and benign recurrent vertigo (BRV), through a multicenter, randomized controlled clinical trial. This study addresses the urgent clinical need for effective therapies for acute dizziness. Additionally, we will dynamically observe the changes in calcitonin gene-related peptide (CGRP) levels before and after treatment and explore the predictive value of CGRP levels for treatment efficacy and the prognosis of recurrence in patients. This study aims to provide a scientific basis to improve clinical management strategies for acute dizziness.

Prospective Registry of Vertigo Due to Vertebrobasilar Transient Attacks.

Vertigo and dizziness are common neurological complaints in the emergency department and may represent a wide spectrum of etiologies, including vertebrobasilar transient neurological attacks (VB-TNAs). Distinguishing VB-TNAs, particularly vertebrobasilar transient ischemic attacks (VB-TIAs), from migraine-like and other non-vascular conditions is often challenging at first presentation due to the absence of specific biomarkers and overlapping clinical features. The UTRAVERA study is a multicenter, prospective, observational investigation designed to characterize the clinical features of patients presenting with acute transient vertigo or dizziness suspected to be VB-TNAs. The study will also evaluate diagnostic evolution over time, treatment responses, and prognostic factors associated with clinical outcomes.

Personalized Brain Stimulation to Treat Chronic Concussive Symptoms

The goal of this study is to investigate a new treatment for chronic symptoms after concussion or mild traumatic brain injury in people aged 18-65 years old. Chronic symptoms could include dizziness, headache, fatigue, brain fog, memory difficulty, sleep disruption, irritability, or anxiety that occurred or worsened after the injury. These symptoms can interfere with daily functioning, causing difficulty returning to physical activity, work, or school. Previous concussion therapies have not been personalized nor involved direct treatments to the brain itself. The treatment being tested in the present study is a noninvasive, personalized form of brain stimulation, called transcranial magnetic stimulation (TMS). The investigators intend to answer the questions: 1. Does personalized TMS improve brain connectivity after concussion? 2. Does personalized TMS improve avoidance behaviors and chronic concussive symptoms? 3. Do the improvements last up to 2 months post-treatment? 4. Are there predictors of treatment response, or who might respond the best? Participants will undergo 14 total visits to University of California Los Angeles (UCLA): 1. One for the baseline symptom assessments and magnetic resonance imaging (MRI) 2. Ten for TMS administration 3. Three for post-treatment symptom assessments and MRIs Participants will have a 66% chance of being assigned to an active TMS group and 33% chance of being assigned to a sham, or inactive, TMS group. The difference is that the active TMS is more likely to cause functional changes in the brain than the inactive TMS.

Efficacy of Non-weight Based, Low Dose Dex-Dex Adjuncts in Prolonging Peripheral Nerve Blocks

The goal of this clinical study is to improve upon the standard practice of utilizing nerve blocks to enhance the satisfaction of patients undergoing shoulder, or foot and ankle surgery regarding their quality of pain control, the duration of their nerve blocks, as well as the avoidance of opioid medications and subsequently their undesirable side effects. The researchers hypothesize that dexmedetomidine and dexamethasone (Dex-Dex) will work synergistically as adjuncts in a low, non-weight based formula. This would allow the investigators to improve patient satisfaction by providing them with a superior means of pain control that is longer in duration with a decreased probability of unwanted side effects. The proposed clinical study will be a prospective, randomized control trial.

THE EFFECT OF SURGICAL MASK AND N95 MASK USE ON SURGICAL SMOKE IN OPERATING ROOM NURSES

This study was conducted to compare the effect of surgical mask and N95 mask use on physical symptoms due to surgical smoke in operating theatre nurses. The study, which was conducted in a single-group prospective quasi-experimental design, was completed with 38 nurses in the operating theatre unit of a state hospital in the Western Black Sea Region. Data were collected for four weeks using the Descriptive Information Form, Numerical Rating Scale and Symptom Follow-up Form. According to the findings, muscle weakness, myalgia in the upper extremities and muscle cramps were statistically significantly less in nurses using N95 masks. Respiratory parameters, watery eyes and redness were significantly lower in nurses using surgical masks. As a result, it was determined that the type of mask was effective on the incidence of physical symptoms related to surgical smoke.

Lost in the Labyrinth: Predicting Central Neurological Causes of Vertigo Dizziness and Unsteadiness in the Emergency Department. A Multicentre Cross-sectional Observational Study

This study will assess the sensitivity and specificity of the bedside examination algorithm performed by ED physicians. Finally, it aims to identify predictors of a central cause of the symptoms. This will consequently reduce the rate of misdiagnosis as well as the costs and length of stay due to inappropriate neuroimaging.

Vestibular Rehabilitation App for Adults With Dizziness Related to mTBI

The goal of this clinical trial is to compare outcomes for standard vestibular rehabilitation home program to a digital vestibular rehabilitation home program in adults with dizziness related to mild traumatic brain injury (mTBI). The main question is whether participants who use the digital format of vestibular rehabilitation improve to a greater extent at discharge than those who use the standard format. Participants will undergo a customized vestibular rehabilitation home exercise program per standard of care, consisting of gaze stabilization, habituation, balance and gait exercises, and endurance training under the supervision of a physical therapist. Participants will complete the gaze stabilization and habituation exercises 2-3 times per day and the balance and gait exercises 1 time per day for 4 weeks. Participants will be tested before and after the 4-week intervention. At the initial session, the researcher will perform standard clinical tests of the inner ear balance system. Also at the initial session, the researcher will perform standard clinical tests of balance and walking and questionnaires about the impact of dizziness on daily activities. At the final session, the researcher will repeat the tests of balance and walking and questionnaires. Three months after completing the intervention participants will complete an online questionnaire about the impact of dizziness on daily activities.

Additional Effects Of Brandt-Daroff Exercises With GANS Maneuver On Dizziness And Quality Of Life In Patients With BPPV

Benign Paroxysmal Positional Vertigo (BPPV) is the most common cause of recurrent vertigo, with a lifetime prevalence of about 2.4% and a yearly incidence of roughly 0.6%. It results from displaced otoconia within the semicircular canals and is especially common in older adults. BPPV leads to brief, position-provoked episodes of vertigo, dizziness, and imbalance, and reduced quality of life. Although canalith-repositioning maneuvers are highly effective, recurrence is common, emphasizing the need for supportive and adjunctive management strategies.This randomized controlled trial will evaluate the Additional Effects OF Brandt-Daroff Exercise With GANS Maneuver On dizziness And Quality of Life In Patients with BPPV. Thirty patients with BPPV will be recruited at Fauji Foundation Hospital and screened using the Dizziness Handicap Inverntory Scale(DHI) and Vestibular Activities and Participation measure(VAP). Participants will be randomized into two groups: (1) Reciving GANS Manuever Alone (2) GANS Manuever with Brandt-Daroff Exercises(3 sessions per week/40minutes). Dizziness will be assessed using the Dizziness Handicap Inverntory Scale(DHI) , quality of life using the Activities and Participation Measure(VAP) Scale. Outcome measures will be recorded at baseline and post-intervention. Ethical approval will be obtained from FUMC ERC, and data will be analyzed using SPSS v.22.

Reducing Vertigo Associated With MRI Machines

Vertigo, dizziness, and imbalance are commonly reported by patients and technologists when near high-field strength magnets (\>4 Tesla, T) used for magnetic resonance imaging (MRI) (1-5) Prior research from the investigators has established that the mechanism is likely a Lorentz force occurring in the inner ear, as a result of interactions with normal electrical currents in the inner ear and the strong static magnetic field of the MRI machine. The investigators have recently developed preliminary data to suggest that slower rates of entry into the magnetic field can greatly attenuate the sensations of vertigo. The explanation for this is that the rates of vestibular adaptation exceed that of the stimulus, allowed a reduction or elimination of the symptoms of vertigo. The aim of this study is to recruit individuals who are already getting an MRI scan as part of other research studies to randomize the rate of entry into and exit from the static magnetic field (i.e., before and after imaging is performed). The usual rate of entry is 20 seconds. This will be increased to one, two or three minutes. The investigators will record subjective sensations of dizziness and vertigo associated with the entry into the MRI.

Chinese Real-world Study of Treatment of Vestibular Migraine

Vestibular migraine is a phenotype of migraine, characterized by more prominent vertigo symptoms compared to headache. Treatments for VM are mainly divided into two categories: acute treatment and preventive treatment. Acute treatment aims to reduce the severity and duration of a single episode, while preventive treatment aims to decrease the frequency, severity, and duration of attacks. Current acute treatments are primarily divided into pain relief and anti-dizziness, with specific drugs such as triptans and ergots being applicable for pain relief, but only betahistine has weak evidence for anti-dizziness, and relevant clinical evidence is very scarce. Preventive treatment mainly refers to migraine preventive treatments, with recommended medications including traditional drugs like topiramate, flunarizine, propranolol, etc., but the efficacy and safety of these drugs are limited. CGRP-targeted drugs are believed to play a role in the preventive treatment of VM, and there are related literature reports, but most are small-sample studies or retrospective studies. This study aims to explore the real-world efficacy of CGRP-targeted drugs in the acute and preventive treatment of VM through a prospective real-world study.

Dizziness Due to Visual Stimuli in Patients With Concussion and Other Causes of Dizziness: Examination of Balance Behaviour

This research project aims to measure how balance is affected by special visual stimulation. Dizziness caused by complex moving visual patterns, known as optokinetic stimulation, is usually called visually induced dizziness (VID). The study includes patients with persistent symptoms after a concussion and those with non-traumatic dizziness. Healthy participants serve as a control group for the comparison of balance and symptom responses. The optokinetic stimulation is done using either a physical rotating disk or a virtual reality (VR) headset. The visual effects are created by bright moving dots. During the stimulation, these patterns move in a specific manner and directions while the subject's balance is recorded. Symptoms such as dizziness, headache, and nausea are also documented. The goal of this project is to improve objective diagnosis of VID. By comparing patients and healthy subjects, the study aim to assess the severity of the disorder. It is also assumed that using different visual stimuli during the balance assessment will offer more sensitive and accurate results. In the long term, this innovative assessment method shall support clinicians to establish the diagnosis of VID, and improve the treatment and management of patients with VID.

Comparing the Effects of Sub-Occipital Myofascial Release With and Without SNAG on People With Cervicogenic Dizziness.

Cervicogenic dizziness is defined as a sensation of rotation, resulting from an alteration of the neck proprioceptive afferents of the upper cervical spine.Sub-occipital Release, a type of Myofascial Release (MFR) is a form of manual therapy technique which can be used for the treatment of cervicogenic dizziness. Sub-occipital muscles, dura matter and C2 vertebrae are connected to each other through the fascia. Sustained natural apophyseal glides (SNAGs) are also an effective treatment for cervicogenic dizziness. This study aim to determine Comparative Effect of Sub-Occipital Myofascial release with and without Sustained Natural Apophyseal Glide among patients with Cervicogenic Dizziness.

Clinical Trial of Vit D and Calcium for Recurrent BPPV

Randomized double blind placebo controlled trial of vitamin D supplements, with or without calcium supplementation, versus placebo in reduction of recurrences in BPPV.

Postoperative Analgesia Between Paravertebral Block and Epidural Block in Esophageal Surgery

Prevention of postoperative pain is essential for the recovery of esophageal surgery. Epidural analgesia is a traditional and standard perioperative pain management for these patients. Beneficials of epidural analgesia have been widely established. However, there are still several potential disadvantages such as perioperative hypotension, failure of administration, rare but serious neurological complications. Ultrasound-guided regional nerve block has become a widely used technique due to its low degree of trauma and precise target of action. In combined with liposome bupivacaine (LB), a new long-acting local anesthetic, was proven to have a maximum duration of 72 hours, thus improving postoperative analgesia, reducing opioid consumption, and enhancing patient satisfaction. The aim of this study was to evaluate the efficacy of TPVB liposomal bupivacaine (LB) or plane bupivacaine (SB) for Overall Benefit of Analgesic Score (OBAS) after esophageal surgery.

Effectiveness of VestAid App

This multi-center randomized trial (MCRT) will investigate the effectiveness of the VestAid application to provide equivalent or faster recovery from dizziness compared to standard-of-care delivery of vestibular rehabilitation exercises.