Clinical Research

Pioneering Rehabilitation

Clinical Research & Clinical Trials

Clinical research and clinical trials are conducted to evaluate the effectiveness and safety of medications medical devices or procedures by studying their effects on human beings. Clinical research trials can be conducted by government agencies such as the National Institutes of Health, researchers affiliated with a hospital or university, independent researchers, or private industry such as pharmaceutical companies. Both the Burke Rehabilitation Hospital and Burke Medical Research Institute conduct clinical trials.

Burke Rehabilitation Hospital and Burke Medical Research Institute actively seek volunteers, also known as study subject to take part in clinical trials. Eligibility to participate in trials is based on pre-determined criteria. Subjects are usually divided into two or more groups, including a control group that does not receive the experimental treatment and receives a placebo instead or receives an already approved treatment for comparison purposes. Government agencies such as the Food and Drug Administration (FDA) either approve or deny approval of new treatments based on the results of clinical trials. Clinical trials are conduced at Burke Rehabilitation Hospital and Burke Medical Research Institute in Westchester County, New York.

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Your search for 'Stroke' matches these Clinical Studies:

  • Stroke

    Mar 11, 2016 (ongoing)

    Evaluation in Secondary Stroke Prevention Comparing the Efficacy and Safety of the Oral Thrombin Inhibitor Dabigatran Etexilate versus Acetylsalicylic Acid in Patients with Embolic Stroke of Undetermined Source (RESPECT ESUS)

    The goal of this study is to test the safety and effectiveness of the anticoagulant dabigatran etexilate (Pradaxa®)  taken twice daily compared to aspirin [acetylsalicylic acid (Acetylsalicylsäure 100 mg HEXAL®)] which is taken once daily for the prevention of stroke recurrence in subjects with ESUS.

    More information on this study, "Randomized, double-blind, Evaluation in secondary stroke prevention comparing the efficacy and safety of the oral Thrombin inhibitor dabigatran etexilate (110mg or 150mg, oral b.i.d) versus acetylsalicylic acid (100 mg oral q.d.) in patients with Embolic Stroke of Undetermined Source (RESPECT ESUS) – 1160.189" can be found here

    This study includes patients 18 years and older after ESUS within the last three months (six months, if aged ≥60 years with additional risk factor) prior to randomization who are eligible for treatment with antithrombotic therapy (i.e. dabigatran etexilate / ASA).

    ESUS, defined as follows:

    • Non-lacunar ischemic stroke detected by Computed Tomography (CT) or Magnetic Resonance Image (MRI)
    • Absence of extracranial/intracranial atherosclerosis causing ≥50% luminal stenosis in artery supplying the area of recent brain ischemia.
    • No major-risk cardioembolic source of embolism
    • No other specific cause of stroke identified (e.g. cerebral arteritis, arterial dissection, migraine with aura/vasospasm, drug abuse)

    Sharon L.Singh
    914-597-2308
    ssingh@burke.org

  • Stroke

    Mar 11, 2016 (ongoing)

    Study to Evaluate the Efficacy and Safety of Two Dose Strengths of Dalfampridine Extended Release Tablets for Treatment of Stable Walking Deficits in Post-Ischemic Stroke (MILESTONE)

    The purpose of the study is to see if taking dalfampridine-ER (Amprya®) tablets twice daily is safe and has an effect on walking abilities in people who have had a stroke.  

    More  information on this study, "A Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Two Dose Strengths of Dalfampridine Extended Release Tablets for Treatment of Stable Walking Deficits in Post-Ischemic Stroke (MILESTONE)," can be found here

    Inclusion criteria include men or women aged 18 years or older who experienced an ischemic stroke 6 months or longer prior to enrollment, clinical evidence of a stable walking deficit due to an ischemic stroke, as judged by the Investigator, based on review of medical records and physical exam, Modified Rankin Scale score of 1- 3, sufficient ambulatory ability to independently complete the 2MinWT and the 10MWT at screening, and Body Mass Index between 18-35 kg/m2 inclusive.

    Key exclusion criteria include previous use of dalfampridine, fampridine or 4-aminopyridine (4-AP), a history of seizures, except simple febrile seizures, moderate to severe renal impairment, severe depression as determined by the Beck Depression Inventory (BDI) score ≥30, diagnosis of multiple sclerosis or a medical or neurological disorder that would interfere with the assessments during the study.

    Sharon L.Singh
    914-597-2308
    ssingh@burke.org

  • Stroke

    Mar 2, 2016 (ongoing)

    The Effects of HT-3951 on Upper Extremity Motor Function Following Ischemic Stroke

    The goal of this study is to assess the effect of the study drug (HT-3951, a reversible Monoamine Oxidase Type B) versus a placebo on motor function improvement in patients who have recently been diagnosed with ischemic stroke and are undergoing rehabilitation therapy for the motor impairment that resulted from the stroke.

    This study also aims to test the safety and tolerability of the study drug (HT-3951) in patients with recent diagnosis of ischemic stroke.­­­­­­

    More information on this study "A Phase 2a, Randomized, Double-Blind, Placebo-Controlled 21-Day Treatment Study, Including an fMRI Sub-study, to Evaluate the Effects of HT-3951 on Upper Extremity Motor Function Following Ischemic Stroke" can be found at ClinicalTrials.gov

    This study includes patients between the ages of 30-85 who have had an ischemic stroke in the past 2-24 weeks. 

    Malia Norman
    914-597-2835
    mnorman@burke.org

  • Stroke

    Sep 25, 2015 (ongoing)

    Transcranial Direct Current Stimulation (tDCS) as an Adjunctive Dysphagia Therapy for Bulbar Dysphagia: A Case Series

    Use of tDCS to enhance swallowing in patients with chronic dysphagia due to brainstem stroke.

    Susan Wortman-Jutt, CCC-SLP
    Dylan Edwards, PT, PhD

    Brainstem stroke with chronic dysphagia.

    Susan Wortman-Jutt, MS CCC-SLP
    (914) 597-2834
    swortman@burke.org 

  • Stroke

    Sponsoring Agency: Nexstim, Inc. | Jun 26, 2014 (ongoing)

    Transcranial Magnetic Stimulation and Task-Oriented Therapy

    The purpose of this study is to determine the effects of transcranial magnetic stimulation (TMS) and one-on-one task-oriented occupational therapy on functional motor recovery in individuals who experience hemiparesis as a result of a stroke.  The program consists of treatment 3 times per week over the course of 6 weeks, or 18 sessions.  

    • >18 years of age
    • An ischemic or hemorrhagic stroke suffered 3-12 months prior to the study
    • No other known brain abnormalities by history
    • A one-sided stroke resulting in upper extremity paresis
    • Some degree of motor dysfunction in the upper extremity 

    Zoe Tsagaris, M.S., OTR/L — Study Coordinator and Clinical Research Therapist
    Phone: (914) 597-2153
    Fax: (914) 368-3117
    kzt3001@med.cornell.edu

                     

  • Stroke

    May 12, 2014 (ongoing)

    Effect of Transcranial Stimulation Techniques on Seated Balance for Patients with Lateropulsion Following Ischemic Stroke.

    To determine if transcranial direct current stimulation or repetitive transcranial magnetic stimulation will create a short-term improvement in seated balance for patients with lateropulsion following ischemic stroke.

    Patients with ischemic stroke who are undergoing active, in-patient rehabilitation and exhibit signs of lateropulsion (also known as "pusher syndrome") following stroke.  

    Michael Reding, M.D.
    (914) 597-2470 
    mreding@burke.org

  • Stroke

    Sponsoring Agency: Dana Foundation | Apr 1, 2012 (ongoing)

    Epigenetic Predictors of Stroke Recovery

    We hope to better understand gene expression patterns via examination of epigenetic modifications in blood born cells.  Identifying genotype-phenotype correlations could lead to discovery of biomarkers that predict recovery after stroke.

    Rajiv Ratan, M.D., Ph.D. and Andrew Goldfine, M.D.

    Patients with a first-time stroke

    Juliana Kennedy, B.S.
    jkennedy@burke.org 

  • Stroke

    Sponsoring Agency: Burke Foundation | Mar 1, 2012 (ongoing)

    Dietary Intervention in Stroke Recovery in the Acute Rehabilitation Setting with the Modified Atkins Diet.

    We aim to examine whether the use of a dietary intervention, the Modified Atkins Diet, can  improve motor recovery in stroke survivors.

    Carolin I Dohle, M.D.; Rajiv Ratan, M.D., Ph.D.

    Patients with a first-time, unilateral, hemispheric stroke who are admitted to the inpatient stroke rehabilitation unit.

    Carolin Dohle, M.D.
    (914) 597-2309
    cdohle@burke.org

  • Stroke

    Sponsoring Agency: NIH | Dec 1, 2011 - Nov 30, 2016

    Robotic Motor Training Combined with Non-Invasive Brain Stimulation to Enhance Motor Control in Hemiplegia

    The goal of this work is to enhance and better understand motor recovery after stroke, and to develop new treatments that maximize this recovery.                            

    Chronic stroke

    Avrielle Rykman M.A., OTR/L
    (914) 597-2220
    Mar Cortes, M.D.
    (914) 368-3181  
    robotics@burke.org

  • Stroke

    Sponsoring Agency: NIH | Nov 10, 2011 (ongoing)

    Evaluation of the variance of transcranial magnetic stimulation (TMS) measures in subacute and chronic stroke and the elderly

    The purpose of this study is to better understand the variance in measures of corticospinal tract integrity and excitability in different populations.  

    Dylan Edwards, Ph.D., P.T.
    Heidi Schambra, M.D.

    Chronic stroke

    Heidi Schambra, M.D.
    (914) 368-3126
    hschambra@burke.org

Archived Projects

  • Stroke

    Sponsoring Agency: Johnson & Johnson | Jan 13, 2011 - Apr 1, 2012

    Application of novel robotic technology to develop sensitive biomarkers

    Longitudinal Study examining neurological & motor recovery Day 7,14,21,30 & 90 post onset of acute CVA 

    Bruce T.Volpe - NY/Cornell

    Inpatients

    Avrielle Rykman, MA,OTR/L
    (914) 597-2220 

  • Stroke

    Sponsoring Agency: Burke Foundation | Mar 1, 2011 - Sep 30, 2012

    Evaluation of the effect of transcranial direct current stimulation and robotic training on clinical, kinematic and neurophysiologic outcomes in subacute stroke patients

    The purpose of this study is to improve upper-limb motor recovery by pairing neuromodulation and robotic training and to characterize the physiology of the recovery. 

    Carolin Dohle, M.D.
    Dylan Edwards, Ph.D., P.T.

    Subacute stroke patients

    Carolin Dohle, M.D.
    (914) 597-2886
    cdohle@burke.org

  • Stroke

    Nov 8, 2011 - Dec 30, 2015

    Transcranial Techniques for Patients with Lateropulsion Following Stroke.

    A study of possible changes in brain activity, as measured by transcranial magnetic stimulation, following the use of transcranial direct current stimulation in patients with lateropulsion ("pusher syndrome") following stroke.

    Suzanne R. Babyar, P.T., Ph.D.
    Dylan Edwards, Ph.D., P.T.
    Michael Reding, M.D.

    Patients with stroke who are undergoing active, in-patient rehabilitation and exhibit signs of lateropulsion (also known as "pusher syndrome") following stroke.

    Suzanne R. Babyar, P.T., Ph.D.
    (914) 597-2839
    sbabyar@burke.org

  • Stroke

    Jun 1, 2014 - Feb 29, 2016

    Determination of Therapeutic Effects of Navigation-Guided 1Hz rTMS Administered to the Contralesional Hemisphere as Adjuvant to Task-Oriented Rehabilitation in Patients with Stroke

    The purpose of this study is to determine the effects of transcranial magnetic stimulation (TMS) and one-on-one task-oriented occupational therapy on functional motor recovery in individuals who experience hemiparesis as a result of a stroke. The program consists of treatment 3 times per week over the course of 6 weeks, or 18 sessions.

    You can learn more about this particular study in our patient handout.

    • >18 years of age 
    • An ischemic or hemorrhagic stroke suffered 3-12 months prior to the study 
    • No other known brain abnormalities by history 
    • A one-sided stroke resulting in upper extremity paresis 
    • Some degree of motor dysfunction in the upper extremity

    Zoe Tsagaris, MS, OTR/L
    Study Coordinator, Clinical Research Therapist
    914-597-2153
    kzt3001@med.cornell.edu

  • Stroke

    Mar 25, 2015 - Mar 24, 2016

    Non-Invasive Repeated Therapeutic Stimulation for Aphasia Recovery (NORTHSTAR)

    The study is part of an international, multicenter proof-of-concept study to investigate the safety, feasibility and efficacy of new non-invasive brain stimulation methods as adjuvant therapies to standard speech therapy for subacute post-stroke aphasia.

    • Inpatients
    • Subacute stroke patients

    Jennie Valles, MD
    (914) 597-2894
    jvalles@Burke.org

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