Clinical Trials

Principal Investigator Kenneth A. Follett, MD, PhD

A Comparison of Best Medical Therapy and Deep Brain Stimulation of Subthalamic Nucleus and Globus Pallidus for the Treatment of Parkinson’s Disease
PD patients may have persistent disabling symptoms even when treated with the best medication regimens available, or they may suffer intolerable medication side effects that limit effective treatment of the disease. Many of these individuals who have symptoms that are refractory to maximum medical management may be candidates for surgical therapy. For most of the past century, surgeons have worked to develop and refine surgical approaches to treating PD. A growing number of studies indicate that deep brain stimulation (DBS) in areas of the brain called the globus pallidus (GPI) or subthalamic nucleus (STN) may relieve or reduce symptoms of PD but it is not known whether the clinical benefit is superior to that achieved with comprehensive (best) medical therapy, whether the clinical benefit is maintained, or which brain structure (i.e., globus pallidus or subthalamic nucleus is the best site for stimulation.

DBS is a promising therapy for PD. Whether DBS is superior to comprehensive (best) medical therapy, whether the effectiveness of DBS differs by site or whether some subjects or symptoms respond better to stimulation in one site or the other is not known. The goal of this project is to study the efficacy of DBS and to compare two sites of bilateral DBS to determine the most effective site for surgical intervention. The findings will be critically important in establishing the optimal surgical treatment of the disabling symptoms of Parkinson’s Disease.
Status: Closed. Study continues with follow-up assessments of subjects.
Contact: Gatana L. Stoner, RN, C.C.R.C.
Phone: (319) 353-6679
E-mail: gatana-stoner@uiowa.edu
Sponsor: NIH and US Department of Veterans Affairs

Principal Investigator Patrick W. Hitchon, MD

Carotid Occlusion Surgery Study NS 42167
This randomized, non-blinded, prospective multi-center study is to determine if surgical anastomosis of the superficial temporal artery to the middle cerebral artery, when added to best medical therapy can reduce by 40%, despite perioperative stroke and death, subsequent ipsilateral ischemic stroke (fatal and non-fatal) at two years in subjects with recently (≤ 120 days) symptomatic internal carotid artery occlusin and ipsilateral increased oxygen extraction fraction measured by positron emission tomography (PET).
Status: Active
Contact: Marge Rogers, RN, or Melanie Frees, RN
Phone: (319) 353-6616 or (319) 384-5824
E-mail: marjory-rogers@uiowa.edu, pamela-jacobs@uiowa.edu or melanie-frees@uiowa.edu
Sponsor: NIH

Principal Investigator Timothy C. Ryken

Gliasite Registry
The purpose of this registry protocol is to assess time to brain tumor recurrence, patient survival, and the incidence of adverse events in patients treated with GliaSite Registry Therapy System.  This is a registry protocol only.  Data will be accumulated from multiple national sites.  The registry is designed to report on the GliaSite Therapy System in the clinical setting.  The purpose is to compile data on the safety, performance and effectiveness of the GliaSite RTS when used for subjects with malignant brain tumors.  This data will be presented and published annually.
Contact: Marge Rogers, RN or Melanie Frees, RN
Phone: (319) 358-5824 or 384-8288
E-mail: melanie-frees@uiowa.edu
marjory-rogers@uiowa.edu
Active: 5/2004
Sponsor: Proxima Therapeutics, Inc.

Treatment of Adults with Newly Diagnosed Glioblastoma Multiforme or Anaplastic Astrocytoma with Surgery, Gliadel Wafers and Limited Field Radiation Plus Concomittant Temozolomide Followed by Adjuvant Temozolomide
This trial is being done at the University of Iowa.  50 Subjects will be enrolled in the study with 44 meeting all criteria to stay in the study.  The primary objective is to determine the safety and feasibility of Gliadel 3.85% wafers plus surgery and limited field radiation therapy with concomittant temozolomide, followed by adjuvant temozolomide, in subjects undergoing initial surgery fir newly-diagnosed, unifocal, supratentorial malignant gliomas.
Contact: Melanie Frees, RN
Phone: (319) 358-5824 or 384-8288
E-mail: melanie-frees@uiowa.edu
Status: Active
Sponsor: Investigator Initiated - UI Hospitals and Clinics