Stroke Clinical Trials

Topic: MAPS (Matrix and Platinum Science Trial)

• Patient is between 18 and 80 years of age
• Patient has an untreated intracranial saccular aneurysm 4-20 mm diameter angiographic lumen, ruptured or unruptured, suitable for embolization with coils
• Both GDC® Coils and Matrix 2® Coils
• Target aneurysm can be coiled at index procedure (NO staged coiling procedures)
• Patient (or patient's legally authorized representative) has provided written informed consent
• Patient is willing and able to comply with protocol follow-up requirements

Exclusion Criteria

• Target aneurysm is not saccular in nature (mycotic, fusiform, dissecting)
• Target aneurysm has been previously treated by surgery or endovascular therapy
• Patient presents as Hunt and Hess grade IV or V for a ruptured aneurysm
• Patient presents with Modified Rankin Score 4 or 5 at baseline
• Patient is concurrently enrolled in another investigational drug or device study unless permission is granted by the sponsor
• Patient has known hypersensitivity to Polyglycolic Polylactic Acid (PGLA), platinum, nickel, stainless steel or structurally related compounds found in Matrix 2® Coils and/or GDC® Coils
• Planned use of adjunctive therapy stents except Neuroform is not allowed
• Patients with multiple aneurysms

Contact: Call Julie Grinde at (608) 262-2939 or e-mail the PI at baagaard-kientiz@uwhealth.org.

Topic: Balance Problems Due to Stroke or Brain Injury

• At least 18 years old
• Documented diagnosis of a stroke or brain injury occurring at least six months ago
• Have reached a plateau and been discharged from physical therapy
• No current oral health problems
• Current balance problem
• Able to ambulate with or without assistance

Exclusion Criteria

• History of seizures
• Implanted electrical medical device (e.g., pacemaker)
• Pregnancy

• You will receive information about your sway through a device that provides touch sensations on your tongue. These sensations are presented through a small, flat electrode array placed on your tongue, which continuously vibrates with a very small electrical stimulation, producing a buzzing or tingling sensation.
• You will participate in a minimum of 10 clinic training sessions.
• After clinic training, you will use the device at home for two 20-minute sessions every day for seven weeks.
• We will assess your balance at the beginning, after clinic training and at the end of the study using standard balance tests and questionnaires.

• Greater than 40 years of age
• Have had an ischemic stroke or TIA within the last six months (must be at least 14 days after stroke to enroll)
• Diagnosis of insulin resistance (defined as having a value over 3.0 on the Homeostasis Model Assessment of insulin sensitivity)

Exclusion Criteria

• Not able to abulate with assistance
• Had stroke related to structural cardiac lesion, significant head trauma, proximal arterial dissection or medical instrumentation
• Diabetes mellitus
• Neurologic/psychiatric disorders
• Pregnancy or desire to become pregnant
• Oral contraceptive use
• Ongoing use of oral corticosteroids
• History of heart failure
• Active liver disease
• History of bladder cancer

More Information

• Insulin resistance is a condition in which insulin, a normal human hormone, does not work effectively because the body is resistant to its effect. Insulin resistance can lead to diabetes and is thought to cause blood vessel diseases, including stroke and heart attack, in patients with and without diabetes.
• Participating stroke patients will be assigned to receive pioglitazone, a medication which reduces insulin resistance, or placebo (an inactive look-alike pill). Patients will stay on their assigned treatment for about four years. At the end of the study, investigators will compare the experience of patients on pioglitazone and placebo to see which group had fewer recurrent strokes and heart attacks.

Study contact phone: (608) 263-9602

Topic: COSS (Carotid Occlusion Surgery Study)

• People who have had a stroke or transient ischemic attack (TIA) within the prior 120 days may be eligible for this study.
• Participants must be 18 – 85 years of age with a totally blocked carotid artery.

• Half of the participants will have surgery and the other half will have the usual care following a stroke or TIA.
• The study will have 10 visits in 24 months.
• A synopsis is available at http://www.cosstrial.org/coss/synopsis.asp.

Topic: SWISS (Siblings With Ischemic Stroke Study)

• If you agree to participate in the study, you will be asked to send study letters to your brothers and sisters who have also had an ischemic stroke inviting them to also take part in the study.
• Once investigators verify that you and your siblings qualify for the SWISS study, a home health care agency representative will make an appointment with you to come to your home and draw blood from you. You do not have to make a special trip to the medical center for a blood draw. Your part in the study is over once your blood is drawn.
• Your DNA will be sent out to the SWISS study investigators to analyze for regions in the human genome that seem to be linked with stroke. We hope to understand what caused your stroke and the strokes of many other people, including your family members.

A synopsis is available at http://www.strokecenter.org/trials/TrialDetail.aspx?tid=236.

Topic: Carotid Endarterectomy

• This study uses various techniques to look at the differences in people who have carotid stenosis. Some have had stroke and some have not. If such differences can be found, it might allow doctors to identify people who have an increased risk of having these types of strokes.
• A research ultrasound of the neck/carotid artery (prior to surgery), a research trans-cranial doppler and a paper and pencil test of how you are thinking will be done prior to your surgery and at 3 months after surgery.

Study contact: (608) 263-4505 or e-mail at pkw@clinicaltrials.wisc.edu.