UTSW Stroke Team
Mobility Foundation Stroke Center
Active Clinical Trials
Timea Hodics, MD
Assistant Professor of Neurology
Mark D. Johnson MD
Associate Professor of Neurology
Jessica Lee, MD
Assistant Professor of Neurology
Worthy Warnack, MD
Associate Professor of Neurology
Amanda Dirickson, RN, MS, ANP-C
Adult Nurse Practitioner
April Blair, MSSW
Research Study Coordinator
Nirav Shah, MD
Research Study Coordinator
Combined Donepezil/Dextroamphetamine Sulfate in the Treatment of Aphasia
Purpose
To compare three groups: combined dextroamphetamine and Donepezil, Donepezil alone, and placebo and determine the efficacy of using pharmacologic treatment paired with learning dependent experience to accelerate recovery from aphasia following stroke.
Design
Randomized, double-blind clinical trial.
Patient Involvement
Participants will receive 36 hours of speech-language therapy over a six-week period. Two sessions per week of the treatment will be paired with dextroamphetamine and donepezil, donepezil alone, or placebo and two sessions per week will be speech-language treatment only.
Primary Outcome
Rate and total amount of recovery of language with methods of assessment including the Porch Index of Communicative Ability (PICA).
COSS
Carotid Occlusion Surgery Study
Purpose
To determine whether surgical anastomosis of the superficial temporal artery to the middle cerebral artery (STA-MCA) in conjunction with the best medical therapy can reduce the incidence of ipsilateral ischemic stroke by at least 40% in patients with symptomatic internal carotid artery (ICA) occlusion.
Design
Randomized, multi-center, partially-blinded, controlled clinical trial. 930 patients will enter the PET screening phase, and 372 will be randomized to surgical or non-surgical treatment.
Patient Involvement
All patients will receive PET scans, and, if indicated, arteriograms. Patients whose PET results indicate increased oxygen extraction will be randomized to either best medical treatment alone, or STA-MCA anastomosis in conjunction with best medical treatment.
Primary Outcome
Combined incidence of stroke and death at 30 days post treatment; incidence of ipsilateral ischemic stroke at 2 years.
IRIS
Insulin Resistance Intervention after Stroke trial
Purpose
To determine the efficacy of pioglitazone in preventing recurrent stroke or heart attack among non-diabetic patients who have had a recent ischemic stroke.
Design
Randomized, placebo-controlled, double blind, multi-center trial.
Patient Involvement
Patients will be randomized to receive either pioglitazone or placebo with follow-up assessments every four months.
Primary Outcome
Cumulative total of fatal and non-fatal strokes and myocardial infarctions.
Secondary Outcome
Progression of diabetes.
Pharmacologic Modulation of Passive Stimulation
To Improve Sensory Function of the Hand Following Stroke
Purpose
To compare dextroamphetamine sulfate to placebo treatment paired with passive stimulation to improve sensory function in the hand and to monitor brain physiological response to behavioral changes with functional MRI in both dextroamphetamine sulfate versus placebo treated individuals.
Design
Randomized, double-blind clinical trial.
Patient Involvement
Participants will receive sensory stimulation to the affected hand for 3 hours per day 4 days per week for 4 weeks. Participants will receive study medication or placebo 2 days per week prior to sensory stimulation. Each participant will receive functional MRI at baseline, 2 weeks into treatment, within 3 days after treatment ends and 4 weeks after treatment ends.
RESPECT
Evaluation of Recurrent Stroke Comparing PFO closure to Established Current Standard of Care Treatment Trial
Purpose
To investigate whether percutaneous PFO closure is better than or equivalent to current standard of care medical therapy in the prevention of recurrent symptomatic stroke.
Design
Multicenter, randomized, active control, blinded adjudicated outcome clinical trial.
Patient Involvement
Patients are randomly assigned to best medical therapy or PFO closure with the AMPLATZER PFO Occluder. Best medical therapy options include aspirin, clopidogrel, aspirin combined with dipyridamole or clopidogrel, or warfarin
Primary Outcome
The primary endpoint is recurrent symptomatic cryptogenic stroke or cardiovascular death. The primary safety endpoint is all adverse effects.
SPS3
Secondary Prevention of Small Subcortical Strokes
Purpose
To investigate the safety and efficacy of antiplatelet and antihypertensive agents in the prevention of secondary stroke, major vascular , and cognitive decline among patients with small subcortical strokes.
Design/Patient Involvement
Multi-center, randomized, double blinded, placebo controlled, factorial design clinical trial
Aspirin vs Aspirin/Clopidogrel.
Two targets of BP control "usual" 130-149 mmHg vs "intensive"(<130 mm Hg).
Primary Outcome
First occurrence during follow up of any stroke, including ischemic or hemorrhagic.
Secondary Outcome
First documentation of major cognitive decline.
SWISS
Siblings with Ischemic Stroke Study
Purpose
A multi-center sibling pairs study to systematically screen for regions on the human chromosome that correlate with the risk of having an ischemic stroke.
Design
Concordant sibling pairs will be studied to see if there exist human chromosomal regions of interest associated with ischemic stroke using DNA samples collected in this study.
Patient Involvement
One time blood sample taken from proband and concordant sibling.
Primary Outcome.
Genetic similarities in ischemic stroke patients.
Transcranial Direct Cortical Stimulation (tDCS)
Enhanced Stroke Recovery and Cortical Reorganization
Purpose
Primary: To test the hypothesis that transcranial Direct Current Stimulation (tDCS) applied in combination with standard rehabilitative training (RT), will enhance motor recovery 3 months after admission in stroke patients relative to placebo and RT.
Secondary: To evaluate if functional recovery is associated with changes in cortical excitability in the ipsilesional primary motor cortex (M1) and dorsal pre-motor cortex.
Design
Randomized, double-blind controlled clinical trial.
Patient Involvement
Eligible patients with weakness in their arm and or hand, within 15 days of their stroke will be randomized either in rehabilitative training (RT) transcranial Direct Current Stimulation (tDCS) or in RT placebo stimulation for 1 hour daily, Monday through Friday for 10 weekdays. tDCS will be applied for first 20 minutes of simultaneous rehabilitative therapy. A subgroup of patients will undergo functional MRI (fMRI) and transcranial magnetic stimulation (TMS) testing.
Healthy volunteers and chronic stroke patients will not participate in the interventional component of the study. They will only participate in testing the experimental paradigm for TMS and fMRI.
Primary Outcome
The primary endpoint is improvement in the Fugl-Meyer motor scale at 3 months.
Transcranial Direct Current Stimulation (tDCS)
In Chronic Stroke Recovery - Pilot
Purpose
To collect pilot information for a subsequent larger clinical trial for the best type of transcranial direct current stimulation (tDCS) in cortical and subcortical strokes and to help evaluate expected effect size in this subsequent larger study.
Design
Randomized, order cross-over, double-blind controlled clinical trial.
Patient Involvement
The first exploratory phase involves chronic stroke patients (stroke more than 3 months ago) to undergo 4 different type of tDCS stimulation, including sham stimulation, concurrently with 1 & ½ hours of physical therapy on each therapy day.
In the second phase of the experiment we will perform only the promising stimulation paradigms plus sham from the first part of the experiment simultaneously with 1 & ½ hours of physical therapy in a random, counterbalanced order. The patient time commitment in the second phase is 12 weeks, where subjects will have 4 x 2 weeks long treatment sessions (10 weekdays) with 1 week inter-treatment “rest period”.
Primary Outcome
First phase: Improvement in upper extremity maximum force, reaction time, motor function test at the end of each session.
Second phase: Improvement in motor scale at the end of each intervention and at 1 week follow-up.
