Filter Results
Clinical Studies
Results filtered:Study status:
Open
Contact Us for the Latest Status
Closed for Enrollment
Contact Us for the Latest Status
Closed for Enrollment
-
A Phase II/III Trial on Rizatriptan for Vestibular Migraine
Rochester, Minn.
The purpose of this study is to look at the natural history of VM and learn more about common symptoms. Investigators also want to learn the effects, both positive and negative, of the commonly used migraine drug, rizatriptan, when it is used for spells of dizziness in people with VM.
Patients may be eligible to participate if:
- Patients are between the ages of 18 & 65
- Patients have a history of vestibular migraine
- Patients are able to maintain a vestibular symptom diary
The study includes 3 visits with compensation. All participants must complete questionnaires on dizziness, headache symptoms, general health and well-being, mental health, and a questionnaire on patient's satisfaction with study medication.
-
A Pilot Project to Investigate the Use of an External Vestibular Prosthesis Potential to Improve Clinical Management of Chronic Subjective Dizziness (CSD)
Rochester, Minn.
This pilot study is focused on what assistance an external prosthetic device, the BalanceBelt™ can provide in the:
- assessment and
- treatment for patients with Chronic Subjective Dizziness (CSD).
The BalanceBelt has sensitive detectors for movement in the anterior/posterior and medial/lateral planes and provides the person wearing the device vibro-tactile feedback as to the persons orientation with respect to gravity. The device is a full self contained device that is comfortably worn around the waist over a light weight shirt. The device is non-FDA approved and is in its final stages of beta testing. Patients with CSD do not have permanent vestibular deficits, but underutilize vestibular signals because they develop visual or somatosensory dependence. The investigators expect the BalanceBeltTM to reset this error by providing patients with reliable motion stimuli.
-
Characterization of Psychological Distress and Its Impact on Health-Related Behaviors in Patients with Symptomatic Heart Failure and Left Ventricular Assist Devices
Rochester, Minn.
The objectives of this study are to use qualitative methods to characterize patients’ distress, to use qualitative methods to explore how distress can impact healthcare behaviors and caregiver support; specifically, their motivation to sustain critical lifestyle changes and provide assertive communication with caregivers and medical teams, and to use qualitative methodology to explore if themes found in patients with symptomatic heart failure (HF) translate to patients with left ventricular assist devices (LVAD) or if they will be superseded by LVAD-specific themes.
-
Diaphragmatic Breathing and Muscle Relaxation: Behavioral Interventions for Gastrointestinal Rumination
Rochester, Minn.
Rumination is an upper gastrointestinal (GI) disorder characterized by the frequent regurgitation of recently ingested food. Very little is understood about the nature and treatment of this disorder. The act of regurgitation in rumination involves the opening of the upper esophageal sphincter and the muscular contraction of the abdomins rectus. Behavioral treatment of these symptoms is the clinical intervention of choice; however, only uncontrolled case documentation exists to support its effectiveness. However, an effective behavioral mechanism may be relaxation of the muscles. From a behavioral standpoint, muscular relaxation is incompatible with the necessary muscular contraction for rumination.
To date, single case documentation and few designed single case studies have examined the clinical effectiveness of behavioral interventions for GI rumination. In the current study, the investigators seek to examine the effectiveness of two behavioral relaxation interventions for GI rumination through a treatment as usual paradigm (proposed N = 20). Our primary goals are to examine the clinical effectiveness of these interventions in symptom reduction at 1- and 3-month follow-up.
-
Effects of Background Composition, Tilt, and Rotation on Accuracy of the Subjective Visual Vertical
Rochester, Minn.
The primary goal of this proposal is to investigate the effects of background content on subjective visual vertical (SVV) error in patients with persistent (>3 months) vertigo, unsteadiness, or dizziness due to neuro-otologic disorders and normal individuals. The secondary goal is to correlate SVV errors with standardized measures of discomfort with space-motion stimuli, dizziness handicap, anxiety, body vigilance, neuroticism, and introversion, all of which have been identified as risk factors or core elements of persistent vestibular symptoms.
-
Pharmacologic Dissection of Vestibular Migraine and Chronic Subjective Dizziness
Rochester, Minn.,
Scottsdale/Phoenix, Ariz.
Chronic dizziness and recurrent vertigo are frequent complaints in primary and specialty medical care settings. Two common causes of these symptoms are vestibular migraine (VM) and chronic subjective dizziness (CSD), which may be seen in up to 25% of patients examined in tertiary neurotology centers. However, VM and CSD are relatively new diagnoses that have not yet been validated. Furthermore, recent research found that they co-exist 30% of the time with overlap in several features. From a clinical standpoint, this makes it difficult to diagnose and treat them well. From a research standpoint, it confounds subject selection for mechanistic investigations.
The primary goal of this study to dissect VM and CSD in order to identify the key features and clarify the diagnostic criteria of each condition. Fifty patients diagnosed with coexisting VM-CSD will be treated with either verapamil or sertraline. Based on clinical and research experience to date, verapamil is thought to have greater effect on migraine-related symptoms, whereas sertraline is thought to have greater effect on CSD-related symptoms. It is hypothesized that a differential treatment response to these two pharmacologic probes will help to tease apart the unique clinical features of VM and CSD and identify risk factors that are shared or separate between the two conditions. The different mechanisms of action of the two study medications may also shed light on the physiologic underpinnings of VM and CSD.
This project will be a 14-week, prospective, randomized, double-blind, parallel group, pharmacologic dissection trial. A 12-week treatment period will follow 2 weeks of baseline observation. Patients will chart daily headache and vestibular symptoms. VM and CSD symptoms and potential confounds such as anxiety and depression will be measured at two week intervals. Data will be analyzed for differential and shared treatment effects that align with or oppose current concepts of VM and CSD.
.