Search Results
Effects of Pallidal Deep Brain Stimulation Location on Motor Impairment in Parkinsons disease; Udall Project 2 Aims 1 & 2 Study
This protocol will characterize the effects of deep brain stimulation (DBS) location (both adverse and beneficial) on motor signs in people with Parkinson’s disease (PD). This information can be used to inform future DBS protocols to tailor stimulation to the specific needs of a patient. If targeted dorsal GP stimulation is shown to significantly improve motor features that are typically resistant to dopamine replacement therapy, these experiments will likely have major impact on clinical practice by providing a potential strategy to these medically intractable symptoms.
Kelly Ryberg - rybe0010@umn.edu
• diagnosis of idiopathic Parkinson's Disease (PD)
• have a deep brain stimulator (DBS)
• have had a 7T brain scan
• history of musculoskeletal disorders that significantly affect movement of the upper or lower limbs
• other significant neurological disorder
• history of dementia or cognitive impairment
• post-operative complications or adverse effects of DBS
Kinematic signatures of postural instability and gait in Parkinson Disease
This is a prospective study aimed at quantifying walking and balance in Parkinson's Disease patients in the clinical setting. To accomplish this, we will use a portable motion capture system that is widely used to study biomechanics in humans. Once quantified, we want to test the effects of deep brain stimulation (DBS) frequency in patients who already have DBS systems in place. Thus, our objectives are: 1. Develop an anonymized database of quantitative postural responses and gait of PD patients. 2. Develop software that can quantify the postural response and gait of PD participants using only standard video camera footage. 3. Test the effectiveness of bilateral high and low frequency STN-DBS on the postural responses and gait of PD patients using the portable motion capture system. 4. We will passively record thalamic LFPs from patients with Medtronic Percept DBS devices while the DBS is OFF, set to low frequency, and set to high frequency.
Thomas Lisko - tlisko@umn.edu
• People diagnosed with Parkinson's disease, with or without implanted Deep Brain Stimulator (DBS). May be at any age of disease progression.
• Healthy adults of similar age to participants who have Parkinson's Disease and are enrolled in the study.
An Open-label, Phase 1/2 Study to Evaluate the Safety and Efficacy of Single-dose PR001A in Infants with Type 2 Gaucher Disease
This is a study to assess the safety and efficacy of PR001A, an Aden-associated (AAV9) viral vector to treat neuronopathic Gaucher disease type 2 (GD2) in infants. PRA001A will be administered via suboccipital injection to the cisterna magna during a single neurosurgical session. GD2 is a fatal disease of early infancy that does not have any therapeutic options beyond palliative care. This study will enroll infants 0-24 months of age.
Brenda Diethelm-Okita - dieth001@umn.edu
• 0 to 24 months of age
• clinical diagnosis on Gaucher disease, Type 2 (GD2)
• Bi-allelic GBA1 mutation
• child has a reliable caregiver (i.e., parent/legal guardian) who is willing and able to participate in the study as a source of information on the patient's health status and cognitive and functional abilities
• diagnosis of a significant CNS disease other than GD2
• able to walk independently
• any other significant medical diagnosis (study staff will review)
• significant laboratory test result abnormalities
• unable to tolerate diagnostic imaging (MRI, CT scan) or unable to tolerate contrast agent
• unable to have sedation or anesthesia
A Phase I/II, Multicenter, Open-Label, Single-Dose, Dose-Ranging Study to Assess the Safety and Tolerability of ST-920, a AAV2/6 Human Alpha Galactosidase A Gene Therapy, in Subjects with Fabry Disease
The proposed study uses a recombinant AAV2/6 vector encoding the cDNA for human α-Gal A (ST-920). The α-Gal A produced by this cDNA has an identical amino acid sequence to the native enzyme, and also to Fabrazyme® (agalsidase beta or equivalent), a clinically approved recombinant protein product. The ST-920 construct encodes a liver-specific promoter, the human α-1-antitrypsin (hAAT) promoter and includes liver-specific regulatory elements. In addition, rAAV2/6 exhibits liver tropism thus providing the potential for long-term hepatic production of α-Gal A in Fabry disease subjects. Studies of ST-920 in a Fabry disease mouse model administered rAAV2/6 encoding hGLA cDNA by intravenous (IV) injection show generation of therapeutic circulating levels of α-Gal A. The one-time treatment with ST-920 minimizes the risk of infusion--related reactions. The goal of ST-920 is to provide stable, long-term production of α-Gal A at therapeutic levels in subjects with Fabry disease. The constant production of α-Gal A in humans should, importantly, enable reduction and potentially clearance of Fabry disease substrates Gb3 and lyso-Gb3.
Brenda Diethelm-Okita - dieth001@umn.edu
• at least 18 years of age
• diagnosis of Fabry disease
• one or more of the following symptoms: i) cornea verticillata, ii) acroparesthesia, iii) anhidrosis, iv) angiokeratoma
• fully vaccinated for COVID- 19 per CDC guidance
• additional requirements apply for cardiac and renal groups (study staff will review)
• history of liver disease
• current or history of use in the last six months of systemic steroids
• other significant medical & mental health diagnosis (study staff will review)
Tissue biopsies for the study of FSHD
A single visit study with muscle and/or skin biopsy / blood draw, performed to determine whether a molecular or cellular defect can be attributed to cells of FSHD muscle. This study is recruiting both individuals with genetically confirmed FSHD as well as unaffected healthy (control) individuals.
Ana Mitanoska - mitan001@umn.edu
• Genetic confirmation of Fascioscapulohumeral Muscular Dystrophy (FSHD)
• at least 4 years old
• Healthy Family Members: parent or sibling of someone who has FSHD
• heart failure, respiratory insufficiency that requires respiratory support
• taking anticoagulants or anti platelet medications (aspirin or NSAIDs)
Building Resilience in Adrenoleukodystrophy with Imaging and Neuropsychology (BRAIN)
This is a prospective, longitudinal cohort study involving data collection regarding performance of children with ALD and typically developing (TD)children on neurocognitive testing and collection of neuroimaging data. The first goal of this study is to understand more about how ALD affects a child’s brain and development in childhood as they take part in their normal medical care and monitoring. This is important to identifying the best ways to detect and treat manifestations of ALD such as cerebral ALD. The second goal is to learn about how ALD affects caregivers, so that clinicians can offer better support to families in the future.
Brain Study - brainstudy@umn.edu
• 3 to 15 years old
• male
• diagnosis of ALD either at-risk for ALD: patients with genetically or biochemically-diagnosed ALD who currently have no evidence of cerebral disease on MRI and b) Cerebral ALD: boys with the cerebral form of ALD who underwent or are undergoing evaluation or treatment for this condition and have early stage disease
• for healthy volunteers: males between 3 and 15 years old
• girls are excluded because this is a genetic disease that only males get
• history of a genetic, neurological, or neurodevelopmental disorder affecting brain development
• history of significant brain insult, infection or injury
A Randomized Trial of Intra-Portal Alone Versus Intra- and Extra- Portal Transplantation of Pancreatic Islets After Total Pancreatectomy for Chronic Pancreatitis (iSite)
One treatment for certain types of chronic pancreatitis is total pancreatectomy with islet autotransplantation (TPIAT). In this procedure, the pancreas is removed (eliminating the source of the pain) and the islets, which produce insulin and other important hormones, are taken from the pancreas and transplanted in to the liver. This is a small study to evaluate a new procedure for transplanting some islets to a new location in the body.
Gregory Beilman - beilman@umn.edu
• age 18- 68
• scheduled for a total pancreatectomy and IAT at University of Minnesota
• diabetes mellitus fasting blood glucose greater than 115mg/dl, or hemoglobin A1c level greater than 6.0%
• use of any of the following treatments in the 30 days prior to enrollment: insulin, metformin, sulfonylureas, glinides, thiazolidinediones, GLP-1 agonists, DPP-4 inhibitors, or amylin
• other medical or mental health diagnosis (study staff with review)
Maternal probiotic supplementation for improved neurodevelopmental outcomes in infants of diabetic mothers (IDMs)
This is pilot study designed to test the hypothesis that maternal probiotic supplementation is associated with infant gut microbiome variation and improved neurodevelopmental outcomes as measured by ERP performance. The primary aim is to determine if maternal probiotic supplementation during pregnancy and lactation is associated with improved recognition memory performance in infants of diabetic mothers (IDMs). This will involve recruitment and enrollment of pregnant mothers who have been diagnosed with gestational diabetes and randomization to an intervention or control group. Women in the intervention group will receive a standardized probiotic supplement during the third trimester of pregnancy through the first month of lactation. We will compare the IDMs who are exposed to probiotics via maternal supplementation or not with respect to auditory and visual ERPs at 1 and 6 months of age to determine if probiotic supplementation is associated with improved hippocampus function in infancy. The secondary aim is to examine whether maternal probiotic supplementation during pregnancy and lactation is associated with differences in maternal milk and infant fecal microbiome signatures as well as maternal milk and infant serum inflammatory protein levels. Microbial analysis will be performed on infant stool and maternal breast milk samples at one and six months of age. Infant serum and maternal breast milk inflammatory protein levels will be measured at one and six months postpartum.
Maria Bunch - mbunch@umn.edu
• pregnant women in their second or third trimester with a diagnosis of gestational diabetes
• screening for gestational diabetes involves a 2-step (screening test followed by a diagnostic test) with screening done between 24 and 28 weeks of gestation in a non-fasting state. If the screening threshold is met or exceeded, patients receive a oral glucose tolerance test (OGTT)
• BMI 18.5-45 kg/m2 at first prenatal visit
• age 21-45 at time of delivery
• pregnant women who report during enrollment procedures that they have social support for and intention to exclusively breastfeed for at least 3 months (breastfeeding intentions are known to be correlated with actual behavior)
• single pregnancy
• alcohol consumption >1 drink per week during pregnancy/lactation
• tobacco consumption during pregnancy or lactation
• inability to speak and understand English
• known congenital metabolic, endocrine disease (other than GDM), or congenital illness affecting infant feeding
• history of type I Diabetes
• mothers currently taking over the counter probiotic preparation
Asymmetries in motor control and their impact on functional independence
We are trying to learn more about how the brain controls movement and how this affects function after stroke. We expect differences in the side of brain damage to result in distinct movements of each arm. We will collect information with standard clinical exams and movements during tasks completed on the Kinereach virtual reality system. We will compare results between people who have and have not had a stroke.
Shanie Jayasinghe - jayas045@umn.edu
• right-handed
• stroke occurred at least 3 months ago
• stroke on only one side of brain
• weakness on one side of the body
• able to understand instructions
• history of more than 1 stroke
• pacemaker
• pregnant
• major psychiatric diagnosis (schizophrenia, major affective disorder, substance abuse requiring hospitalization)
• significant joint pain
• arthritis
• neurological disease other than stroke
• taking prescription drugs with sedative properties
• unable to have a MRI
Wearable monitor for FOG detection
Freezing of gait is a common problem in people with Parkinson's disease. Episodes of freezing can be overcome when a sensory cue is provided. This study will further develop and study the efficacy of a wireless shoe insole that can monitor walking and provide a cue (acoustic or vibrotactile) when a freezing event is detected. The experiment is designed to further test the ability of the device and algorithm to reliably detect freezing and release the episode with an external cue. This study has the potential to develop a tool that can help reduce the incidence and severity of freezing events in people with Parkinson's disease.
Madison Wylie - aasen056@umn.edu
• Age: 21 to 75 years
• Able to walk independently without the assistance of a walking aid
• History of musculoskeletal disorders
• Other significant neurological disorders
• Hallucinations
• Unable to walk
• Legally Blind
• Symptomatic low blood pressure
• Additional exclusion criteria for young and healthy controls: diagnosis of Parkinson’s disease, or a family member with a diagnosis of Parkinson’s disease.
Neurobiological and Psychological Maintenance Mechanisms Associated with Anticipatory Rewards in Bulimia Nervosa
The purpose of this investigation is to identify the potentially crucial role of anticipatory reward mechanisms maintaining bulimic behavior (i.e., binge eating and purging) in bulimia nervosa (BN).
Emma Rasmussen - rasmu960@umn.edu
• ages 18 to 55 years
• right handed
• able to read and speak English
• at least one bulimic episode and one self-induced vomiting episode per week for at least three months
• stable dose (for at least 6 weeks) in medication that affects mood, appetite, or weight
• For Healthy Participants: right handed, speak and read English, no history of eating disorder
• history of gastric bypass
• current medical or psychiatric illness instability (e.g. hospitalization in past 3 months
• history of psychosis or bipolar disorder
• current substance use disorder
• neurological disease
• BMI less than 19 kg/m^2
Wearable sensors for the combined use of early detection of postural instability and fall risk prediction in Parkinson s disease patients
This is a prospective study aimed at quantifying walking and balance in patients with parkinsonism in the clinical setting in addition to a living environment setting. To accomplish this, we will use a portable motion capture system that is widely used to study biomechanics in humans. Once quantified, we want to test the effects of deep brain stimulation (DBS) frequency in patients who already have DBS systems in place. Thus, our objectives are: 1. Demonstrate that parkinsonism patient-specific kinematics can be used to detect postural instability in the clinic using wearable IMUs. 2. Demonstrate that individualized, home-based postural response curves can detect postural instability and prospectively predict fall risk in patients with parkinsonism.
Thomas Lisko - tlisko@umn.edu
• Anyone who has been diagnosed with parkinsonism including Parkinsons disease, Normal Pressure Hydrocephalus, or atypical parkinsonism
• Healthy adults of similar age as study participants
• people who have dementia of sufficient severity to impair their ability to make health-care decisions for themselves
Determinants of Renal Structural Responses to Enzyme Replacement Therapy (ERT) in Fabry Disease Study (LDN6702)
The effect of enzyme replacement therapy on how well your kidneys are responding to enzyme replacement therapy (ERT) is not clear from blood and urine tests alone, but may be more clear in comparisons of kidney biopsies performed before and some time after ERT has been initiated, and this is what we are focusing our study efforts on. The purpose of this study is to obtain your permission to allow us to study the kidney biopsy tissues (collected for medical reasons) after the regular routine studies have been completed. Through our special research measurements and additional study, we hope to be able to see and measure very specific changes in the kidney tissues from Fabry patients taking ERT. We also hope that through these studies of what happens within the kidney before and after starting ERT, we are able to reveal valuable information about the importance of factors like your age that you started ERT, the amount or dosage of ERT, and any differences seen between males and females.
Michael Mauer - mauer002@umn.edu
• diagnosed with Fabry disease and a clinical decision has been made to obtain a kidney biopsy, a GFR, and urinary albumin studies
• have previously completed clinical trials which included measures of renal function and renal biopsies
• serum creatinine more than 2.5 mg/dL
• known to have a renal disease other than Fabry
Improving Diagnosis and Treatment in Catecholaminergic Polymorphic Ventricular Tachycardia (CPVT)
This is a multi-center, prospective, observational cohort registry study looking at kids and their relatives with Catecholaminergic Polymorphic Ventricular Tachycardia (CPVT).
Brittany Faanes - grego318@umn.edu
• anyone diagnosed with CPVT before 19 years of age.
• significant medical history that isn't related to CPVT
The (IRAD) International Registry for Acute Aortic Dissection (CCMOCPAAD)
The International Registry of Aortic Dissection (IRAD) was created in 1996 by cardiovascular specialists committed to expanding current knowledge of aortic dissection with the goal of improving patient outcomes. This registry study uses a standardized form to capture data from consecutive patients with aortic dissection at participating hospitals.
Nicholas Lemke - ntlemke@umn.edu
• 18 to 80 years of age
• clinical diagnosis of acute aortic dissection
• Type A dissection
• Type B dissection
• Retrograde type B dissection
• Aortic aneurysm
• Myocardial infarction
• Cerebral accident
• Active infection
Corrona Inflammatory Bowel Disease (IBD) Registry
This is a prospective, non-interventional, research study for patients with IBD under the care of a certified gastroenterologist. The primary objective for this registry is to prospectively study the natural history of IBD, the prevalence and incidence of comorbidities, targeted adverse events, and more, via questionnaires.
Lulu Chen - chen8124@umn.edu
• at least 18 years old
• Diagnosis of one of the following by a gastroenterologist: Crohn's disease or Ulcerative colitis (UC)
• users of an approved biologic drug or JAK inhibitor (Tofacitinib) for the treatment of UC or Crohn's disease
• Participating in or planning to participate in a clinical trial studying new medications for Crohn's disease or Ulcerative colitis
Safety and Acceptability of Patient -administered Sedation During Mechanical Ventilation
The primary objective of the study is to assess the efficacy of patient controlled sedation (Self-management of sedative therapy) using dexmedetomidine to reduce anxiety, delirium incidence and duration of mechanical ventilation compared to usual sedation practices in mechanically ventilated subjects.
Linda Asubonteng - asub0002@umn.edu
• receiving mechanical ventilation (ventilator) in the Intensive Care Unit
• receiving medication for sedation or pain
• prone (facing down) ventilation being used
• low blood pressure that is being treated with medication
• unstable medical condition (staff will review)
Focus in NeuroDevelopment (FIND) Network: A Statewide Network for Research in Neurodevelopment
The purpose of this research project is to develop a registry and database of families with neurodevelopmental disorders.
Shelby Wren - flana064@umn.edu
• All ages
• All individuals with disabilities and families within the neurodevelopmental disorder community
• Also looking for clinicians, educators, and professionals in the field
Graded Motor Imagery for Women at Risk for Developing Type I CRPS following Distal Radius Fractures
Background: Distal radius fractures (DRF) account for nearly one-fifth of all fractures in older adults, and women experience them 5x as often as men. Most DRF occur with low impact injuries to the wrist with an outstretched hand, and are often managed via closed treatment and cast immobilization. Women sustaining a DRF are at risk for upper limb immobility, sensorimotor changes, edema and type I complex regional pain syndrome (CRPS). Since CRPS onset is likely influenced by alterations in the brain’s somatosensory region, a rehabilitation intervention, Graded Motor Imagery (GMI), aims to restore cortical representation, including sensory and motor function, of the affected limb. To date, there are no studies on the use of GMI in reducing risk of or preventing the onset of type I CRPS in women with DRF treated with cast immobilization. Due to a higher likelihood of women with this injury developing type I CRPS, it is important to early intervention is needed. Methods/Design: This article describes a six-week randomized comparative effectiveness trial, where the outcomes of a modified GMI program (mGMI) + standard of care (SOC) group (n=33) are compared to a SOC only control group (n=33). Immediately following cast immobilization, both groups participate in four 1-hour clinic-based sessions, and a home program for 10 minutes three times daily until cast removal. Blinded assessments occur within 1 week of cast immobilization (baseline), at three weeks post cast immbolization, cast removal, and at three months post cast removal. The primary outcomes are patient reported wrist/hand function and symptomology on the Patient Rated Wristand Hand Evaluation, McGill Pain Questionnaire, and Budapest CRPS Criteria. The secondary outcomes are grip strength, active range of motion as per goniometry, circumferential edema measurements, and joint position sense. Discussion: This study will investigate the early effects of mGMI + SOC hand therapy compared to SOC alone. We intend to investigate whether an intervention, specifically mGMI, used to treat preexisiting pain and motor dysfunction might also be used to mitigate these problems prior to their onset. If positive effects are observed, mGMI + SOC may be considered for incorporation into early rehabilitation program.
Corey McGee - mcge0062@umn.edu
• age 55 and older
• received closed treatment of distal radius fractures
• central nervous system disorders (e.g., Brain injury, Spinal Cord Injury, Parkinson's, Multiple Sclerosis)
• surgical fixation of fracture
• non english speaking
• multiple fractures to the same arm
• conditions of the opposite upper limb which would result in painful and markedly limited active hand, wrist and forearm motion
• cognitive disorders which make it difficult to follow testing commands and home program participation
• significant visual impairment
Synergistic Enteral Regimen for Treatment of the Gangliosidoses (SYNER-G) (Syner-G)
The Syner-G regimen research study seeks to evaluate the use of a combination of a medication called miglustat and a ketogenic diet for treatment of the gangliosidoses to learn if this combination will provide improved clinical outcomes compared to what we currently know about the natural course of the disease.
Jeanine Jarnes - utzx0002@umn.edu
• no more than 17 years old
• documented infantile or juvenile gangliosidosis disease
• severe kidney disease
• females who are pregnant or breast feeding
• females who are post puberty who are unwilling to use highly effective birth control
A Natural History Study of the Gangliosidoses
This study's primary aims are to define and characterize disease progression for the infantile and juvenile forms of the gangliosidoses, and the late-onset forms of gangliosidosis, including their heterogeneity; and to observe treatment outcomes for any treatments tried. The secondary aims of this study are to understand the neurological involvement in late-onset gangliosidosis; and to collect data on disease progression that can be used for creation of an objective disease stage and severity index.
Jeanine Jarnes - utzx0002@umn.edu
• documented gangliosidosis disease
• able to complete neuropsychological and neurobehavioral assessments
• Late-onset gangliosidosis subjects must be able to tolerate MRI of the head
• none