Neurology : Research - Clinical Research

Department of Neurology Clinical Research

What does participation involve?

• Most clinical trials involve numerous visits to the clinic or hospital for exams & tests
• If you qualify for a trial you must return to the office or clinic for regular appointments
• You will be given study medication or placebo to take with the medication you are already taking to treat your disease

 CLINICAL TRIAL STAFF RESPONSIBILITIES

• Help you, the patient, understand the purpose of the study
• Explain risks and benefits
• Inform you of what to expect as a participant in the study
• Keep you safe and protected

 EPILEPSY

 Faculty at the University of Toledo are currently involved in multiple areas of research in epilepsy. These  include:

• Hormones and epilepsy
• Depression and epilepsy
• Bone density in patients on epilepsy medications
• Basic mechanisms of epilepsy
• New medications for treatment of epilepsy

 Do you have uncontrolled partial seizures? 

• We have ongoing studies involving oral tablets to add on to your current treatment (add-on therapy) or to take instead of your current treatment (monotherapy)
•  Intended to test investigational drugs to see if they can reduce the frequency of seizures.

Please contact:
Kim Cole, CNP * 419-383-6783 * kimberly.cole@utoledo.edu

• If you are female over the age of 18, of childbearing potential, and interested in a study of seizures that occur around your period (catamenial epilepsy), please contact:

Kim Wilson, LSW, Certified Clinical Research Professional   *  419-383-5461 * kimberly.wilson@utoledo.edu

HEADACHE

Have you been told by a doctor that you have migraine headaches? 
Have you ever had a headache last longer than three hours when treated?
Have you ever had a headache make you nauseous, light or sound sensitive, or limited daily activity?

• You may be eligible to participate if you are a woman over the age of 18.  Please contact:

Kellie Janke * 419-383-5309 * kellie.janke@utoledo.edu

• If you are between the age of 18 and 65 and have failed any of the following short acting triptans, Maxalt (rizatriptan), Imitrex (sumatriptan), Axert (almotriptan), Zomig (zolmitriptan), or Relpax (eletriptan), please contact:

Jody Hamilton * 419-383-4516 * jody.hamilton@utoledo.edu

MULTIPLE SCLEROSIS

Purpose of Multiple Sclerosis Research in the Department of Neurology:

• Speed the development of treatments, prevention and cure
• Gain better understanding of the disease
• Improve quality of life for MS patients
• Of the current Federal Drug Administration ( FDA)-approved treatments, none can provide a cure or prevent recurring symptoms

Have you been diagnosed with relapsing-remitting multiple sclerosis?  The Department of Neurology is currently recruiting for an investigational study that combines the use of Copaxone and Avonex to study the effectiveness on the treatment of Multiple Sclerosis.

Please contact:
Andrea Korsnack, RN, Certified Clinical Research Coordinator * 419-383-3801 * andrea.korsnack@utoledo.edu

Have you rejected the use of injectibles in your treatment of MS?  The Department of Neurology is currently recruiting for an investigational study that will evaluate the efficacy and safety of an oral tablet.

Please contact:
Kim Wilson, LSW, Certified Clinical Research Professional * 419-383-5461 * kimberly.wilson@utoledo.edu

STROKE

Purpose of Stroke Research in the Department of Neurology:

• Speed the development of treatments and preventions
• Gain better understanding of the disease
• Improve quality of life for stroke patients

Stroke Prevention

1.  This clinical protocol is designed to assess and compare the outcome of a Patent Foramen Ovale (a PFO is a small hole or flap between the two sides of the heart) closure system versus best medical treatment of patients with stroke or Trancient Ischemic Attach (TIA) due to presumed paradoxical embolism. 

You may be eligible to participate if you are between the ages of 18 and 60, have had a positive contrast bubble study by Transesophageal Echocardiogram (TEE), demonstrating right to left shunting through a Patent Foramen Ovale (PFO), and have had a stroke or Transient Ischemic Attack (TIA) in the past six months.

2.  This clinical trial will examine a new therapeutic approach that is based on the detection and treatment of insulin resistance – the body’s reduced ability to process the sugars in food . In epidemiologic research (the study of factors affecting health and illness), insulin resistance has been associated with increased risk for stroke, and several vascular risk factors.  Based on these associations investigators have hypothesized that modification of insulin resistance may reduce the incidence of stroke and heart attack (Myocardial Infarction).

You may be eligible to participate if you are 45 or older and have had an ischemic stroke or TIA within the past six months.

 Acute stroke studies

This clinical trial beginning treatment within 6 hours of stroke onset should establish that an infusion of an experimental fibrinolytic vs placebo is a safe and effective treatment for subjects with acute ischemic stroke. 

You may be eligible to participate if you have a diagnosis of stroke based on a physical examination conducted by a neurologist.  Administration of the study medication is to begin within 6 hours of stroke symptoms

For more information on the UTMC stroke program contact:

Andrea Korsnack, RN, Certified Clinical Research Coordinator * 419-383-3801 * andrea.korsnack@utoledo.edu.

PARKINSON’S DISEASE

Parkinson’s Disease (PD) can affect anyone.  The average age of onset is around 55 - 60 years old, though it can appear at a much younger age. PD patients come from all walks of life:

• Homemakers, farmers, teachers, doctors…
• As well as some famous people:

• Michael J. Fox - actor

  Muhammad Ali – boxing champion

  Janet Reno – former US Attorney General

The typical symptoms of PD at diagnosis are:

• Tremor – rhythmic motions usually beginning in one hand
• Rigidity – resistance to passive movement
• Bradykinesia – slowness of voluntary movements

 PD patients may also experience:

• subtle changes in posture, shortened steps or shuffling, or “freezing” which is uncontrollable stops while walking
• speech, voice, and swallowing issues
• gastrointestinal issues such as nausea and constipation
• sleep disorders
• neuropsychiatric issues such as depression and/or anxiety

Prior to 1990 there were only a handful of therapies for the treatment of Parkinson’s Disease and the side effects that result from its primary treatment.  Today there are almost three times as many - due in large part to the hard work of diligent and conscientious researchers.  In just the last year alone three new pharmaceutical treatments have been approved by the FDA.

At any given time, the Parkinson’s Disease and Movement Disorders Program of The University of Toledo’s Department of Neurology has a number of ongoing and enrolling clinical trials for:

• Patients newly diagnosed with Parkinsons disease who have not yet started standard therapy
• Trials for “fluctuators” – those patients who experience periods of time when their PD medications are not working optimally
• Patients who are experiencing side effects from their PD medications
• Patients with siblings who are have been diagnosed with PD or are exhibiting signs of PD

For more information on any of our studies, or on the Parkinson’s Disease and Movement Disorders Program as a whole, please contact:

Julia Spears, C.C.R.C., Research Administrator *419.383.6728 * julia.spears@utoledo.edu
OR
Kathy Davis, R.N., Certified Clinical Research Coordinator *419.383.3548 * kathy.davis@utoledo.edu

This information has been reviewed and approved by The University of Toledo’s Biomedical Institutional Review Board, June 21, 2007.