Research: Clinical Studies
Department researchers are also conducting a wide variety of clinical studies in diabetic neuropathy, epilepsy, multiple sclerosis, neuromuscular disease, neuropyschology, pain management and stroke. The studies are focused on novel medical treatments and therapies.
For more information on the trials listed below please contact:
Inquiry number: 1-800-755-5667
UW Health Neurologists are engaged in clinical research in areas including:
Multiple Sclerosis | Epilepsy | Stroke | Parkinson's disease
BRAIN STIMULATION TRIAL IN HEALTHY ADULTS AND ADULTS WITH DOWN SYNDROME
PI: Hrissanthi Ikonomidou, MD, PhD
Study Title: Phase I Trial of the Feasibility and Dose Tolerability of High Definition Transcranial
Direct Current Stimulation in healthy adults and adults with Down Syndrome
HS IRB#: 2014-0262
Inviting Healthy Adults, ages 18-45 years, to participate in a 12-week Clinical Trial at the
University of Wisconsin, Madison
We are a group of Child Neurologists and Neuropsychologists at the University of Wisconsin-
Madison. We are planning a clinical trial using the technique of high definition-transcranial
direct current stimulation. Transcranial direct current stimulation (HD-tDCS) is a method which
enables noninvasive electrical stimulation of the brain via electrodes placed on the skull. Our
goal is to explore whether this treatment is well tolerated in adults (age 18-45). Our ultimate
longer term goal is to use this technique in a bigger and longer clinical trial and explore whether
it can help improve cognitive skills and IQ in 5-8 year old children with Down syndrome. The
University of Wisconsin Health Sciences Investigational Review Board has reviewed our plans and has
given us official permission to proceed.
We are currently looking for 18-45 year old adults. Study participation will take place at the
University of Wisconsin Health Sciences Center or the University of Wisconsin Hospitals and Clinics
and will last up to 12 weeks and involves; 4 study visits before, during, and after a 4-6-week
session with high definition transcranial direct current stimulation (HD-tDCS). HD-tDCS is a
method which uses electrical stimulation of the brain via electrodes placed on the head. All study
visits will occur at the University of Wisconsin and the University of Wisconsin Hospitals and
You will be compensated $250 upon completion of participation.
If you are interested and would like to learn more about the study, please call or send a brief
email or letter to the following contact:
Chris Ikonomidou, MD PhD Professor of Child Neurology
Department of Neurology University of
1685 Highland Avenue
Madison, WI 53705
Tel: 608 2635421
Title: Biogen 109-MS-303
PI: Christopher Luzzio, MD
Sponsor: Biogen Idec
Title: Helminth-induced immunomodulation therapy (HINT Phase 2)
PI: John Fleming, MD
Sponsor: National Multiple Sclerosis Society
This study is anticipated to begin in September 2009. Fifteen patients newly diagnosed Relapsing-Remitting Multiple Sclerosis and treatment naïve will be recruited. The study will evaluate safety, tolerability and effectiveness of the Helminth-induced immunomodulation therapy (HINT) in patients with relapsing-remitting multiple sclerosis (RRMS). The primary outcome measure will be MS activity, as judged by the number of new gadolinium-enhancing (n-gd+) lesions on serial MRI scans. Secondary outcomes will include immunological assessments on serum and peripheral blood mononuclear cells; and changes in MS clinical status.
Title: Novartis CFTY720D2306
PI: Christopher Luzzio, MD
Sponsor: Novartis Pharmaceuticals Corporation
This study is anticipated to begin in October 2009. The purpose of this study is to evaluate the safety and tolerability as well as the effectiveness of an investigational oral medication in delaying disability progression in patients with Primary Progressive Multiple Sclerosis. The study will consist of a pre-treatment phase and a 3 year treatment phase.
Title: Study of CCSVI in MS using quantitative time-resolved 3D MRV
The study is a phase-II retrospective validation study of a binary diagnostic test (imaging-based detection of chronic cerebrospinal venous insufficiency (CCSVI) and its ability to diagnose clinically definite MS. We will compare the following three groups: (1) MS patients, (2) subjects with other neurological disease controls and (3) Healthy controls. Enrollment is ongoing. The specific aims of the study include:
- Independently confirm or refute the recent findings of Zamboni and colleagues with respect to a putative relationship between chronic cerebrospinal venous insufficiency (CCSVI) and multiple sclerosis (MS); specifically, determine the sensitivity, specificity, and odds ratio for predicting the diagnosis of MS from the presence of CCSVI.
- Determine whether the severity, extent, or specific pattern of CCSVI predicts not only the presence of MS (Specific Aim #1) but also regionally specific disease burden, as objectively measured by conventional brain and spinal cord lesion volumes as well as advanced, quantitative MRI assessment of normal-appearing cerebral white matter.
Title: Advanced Quantitative Magnetization Transfer Imaging in Multiple Sclerosis Disease
The broad, long-term objective of this research is to develop a noninvasive imaging approach based on magnetization transfer that is sensitive and specific to various pathological substrates of MS disease, the ultimate goal being to guide the diagnosis and therapy of MS. Our hypothesis is that the quantitative MTI methods will be more predictive of disability and disease course than existing, clinically feasible imaging markers, owing to greater sensitivity, specificity, and reliability provided by the more sophisticated modeling of MT phenomena that we propose. The specific aim is measure the ability of qMTI biomarkers to predict clinical disability and new active lesions and compare with conventional MRI in a small series of MS patients and age-matched controls. Enrollment is closed but the study continues to have active participants in follow-up.
Title: Voxel-Wise Time-Series Analysis of Quantitative MRI in Relapsing-Remitting MS
The overarching goal of the project is to definitively validate the “preactive” lesion hypothesis in MS3, 13 and to identify the spatiotemporal imaging signature of white matter destined to undergo acute, focal inflammation and demyelination—specifically, one that will allow reliable, prospective detection of nascent lesions before they appear on conventional (non-quantitative) imaging. Ten patients, age 20-69 years, meeting McDonald 2010 criteria for RRMS and declining disease-modifying medication will be studied. Enrollment is ongoing.
Title: Open Label Study to Evaluate the Safety of Copaxone and to Monitor the Neurologic Course of Disease in Multiple Sclerosis Patients Treated with Copaxone
This study will continue to provide information regarding the safety of administration of Copaxone to a large number of patients. It will also provide information regarding the safety of Copaxone administered for up to twenty-two years, or until the sponsor terminates the study. Enrollment is closed but the study continues to have active participants in follow-up.
Title: A double-blind, randomized, multicenter, placebo-controlled, parallel-group study comparing the efficacy and safety of 0.5 mg fingolimod administered orally once daily versus placebo in patients with primary progressive multiple sclerosis - CFTY720D2306
The purpose of this study is to evaluate the safety and tolerability as well as the effectiveness of an investigational oral medication in delaying disability progression in patients with Primary Progressive Multiple Sclerosis. The study will consist of a pre-treatment phase and a 3 year treatment phase. Enrollment is closed but the study continues to have active participants in follow-up. .
Title: A Dose-Blind, Multicenter, Extension Study to Determine the Long-Term Safety and Efficacy of Two Doses of BG00012 Monotherapy in Subjects with Relapsing-Remitting Multiple Sclerosis
Primary objective of the study is to evaluate the long-term safety profile of BG00012. Enrollmet closed but the study continues to have active participants in follow-up.
Title: NP10005 RNS LTT: RNS™ System Long-term Treatment Clinical Investigation
PI: Paul Rutecki, MD
Sponsor: Neuropace, Inc
The RNS System Pivotal Clinical Investigation is designed to determine whether the Responsive Neurostimulator (RNS) system is safe and is effective as an adjunctive therapy in reducing the frequency of seizures in individuals 18 years of age or older with partial onset seizures that are refractory to two or more antiepileptic medications. This study is no longer enrolling but continues to have active participants.
Title: Neuropsychological Progression in New Onset Epilepsy
PI: Bruce Hermann, PhD
This project is the first prospective cohort investigation of children with new onset epilepsy designed to characterize the etiology and natural history of neurodevelopmental abnormalities in cognition, brain structure, and psychopathology. The long term goal is to understand the causes and earliest risk factors predictive of adverse quality of life outcomes of childhood onset epilepsy.
This combined cross-sectional and longitudinal cohort study involves: a) a 10 year follow up of cognition, brain structure, and mental health of the initial cohort (75 children with new onset epilepsy and 62 healthy controls), b) enrichment of the cohort with 75 children with new onset epilepsy and 75 and controls, and c) the addition of new neuroimaging, cognitive, and psychiatric procedures designed to address hypotheses regarding the neurobiology of critical cognitive and behavioral comorbidities as well as the impact of epilepsy on cognitive and brain development.
The specific aims of this application are: 1) Characterize the long term (10 year) course of cognitive development, brain maturation, and psychopathology associated with neurobehavioral comorbidities in new onset childhood epilepsy. 2) Characterize the contribution of family history to the risk of neurobehavioral comorbidities in new onset epilepsy. 3) Identify the unique abnormalities in cortical morphology associated with neurobehavioral comorbidities in new onset epilepsy. 4) Characterize abnormalities in baseline and prospective cerebral white matter development and the clinical significance of identified abnormalities in new onset epilepsy. 5) Determine the association between neurobehavioral comorbidities and epilepsy syndrome as well as the distinct cognitive and neuroimaging profiles of comorbidity subtypes.
Childhood epilepsy is a prevalent neurological disorder associated with poor outcomes in key aspects of adult life compared to the general population (e.g., employment and finances; marriage and family; social and psychiatric status), the causes of which remain poorly understood. The results of this controlled prospective cohort investigation will provide what we believe are the earliest insights into the natural history of these lifespan outcomes.
Title: Insulin Resistance Intervention after Stroke Trial (IRIS)
PI: Justin Sattin, MD
Sponsor: Yale University
This is a randomized, double-blinded, placebo-controlled trial of pioglitazone (Actos) for the prevention of recurrent stroke and other vascular events. The trial includes subjects who are not diabetic, but have insulin resistance as determined by an investigational blood test.
Title: Platelet-oriented Inhibition in New TIA and minor ischemic stroke (POINT) Trial, a prospective, randomized, double-blind, multi-center trial (POINT) (Co-I- Sattin)
The primary study objective is to determine whether Clopidogrel 75 mg/day after a loading dose of 600 mg of Clopidogrel is effective in preoventing major ischemic vascular events ((ischemic stroke, myocardial infarction, and ischemic vascular death) at 90 days when subjects are randomized within 12 hours of time last known free of new ischemic symptoms in patients receiving aspirin 50-325 mg/day (with a dose of 162 mg daily for 5 days followed by 81 mg daily strongly recommended). Currently enrolling.
Title: longitudinal MRI biomarkers in Parkinson's disease
PI: Cathy Gallagher, MD
Sponsor: Department of Veterans Affairs MERIT Award (7/2012-7/2016)
This study will evaluate how Magnetic Resonance Imaging (MRI) measures of connections between brain regions are related to clinical symptoms, and how the measures evolve with disease progression. The goal of the study is to identify non-invasive candidate markers for disease-related brain changes.