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.

Search Results

Viewing all current Clinical Studies:

  • Spinal Cord

    Sponsoring Agency: Ekso Bionics Holdings, Inc. | Aug 22, 2016 (ongoing)

    WISE (Walking Improvement for SCI with Exoskeletons) Study

    The randomized, controlled study, entitled WISE (Walking Improvement for SCI with Exoskeletons), will evaluate improvement in independent gait speeds of spinal cord injury (SCI) patients undergoing rehabilitation with the Ekso GT™, the Ekso Bionics' medical robotic exoskeleton, and will be compared to both conventional therapy and usual care control groups. The US-based study, which will be conducted in up to 8 centers, seeks to enroll approximately 160 community dwelling people with chronic incomplete SCI.

    The multicenter WISE study incorporates three randomized clinical arms as follows:

    • Participants randomized to Group 1 will receive the Ekso GT for rehabilitation three times a week for 12 weeks;
    • Participants randomized to Group 2 will receive standard gait training for rehabilitation three times a week using a combination of body-weight supported treadmill training and overground training for 12 weeks;
    • Participants randomized to Group 3 will be a passive control group in which participants continue with daily activities as normal over 12 weeks with no therapy.

    In addition there will be a “run in” group of up to 40 participants who will serve to help with protocol refinement.  Participants in the “run in” group will receive the Ekso GT for rehabilitation and will be followed for 12 weeks.

    All groups will be evaluated at baseline, 6 weeks, and 12 weeks. The primary endpoint of the WISE study seeks to demonstrate that a 12-week robotic gait training regimen can lead to a clinically meaningful improvement in independent walking speed. Secondary endpoints from the trial will examine economic factors such as number of physical therapists (PTs) and staff required during training, the physical burden on PTs assisting and supervising during training and the influence of factors that may modify the gait recovery.

    Chronic incomplete spinal cord injury (SCI) patients undergoing rehabilitation.

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

    Helma Zanders
    (914) 597-2111

    Robotics@burke.org

  • Dementia

    Jun 13, 2016 (ongoing)

    A Phase III Safety and Efficacy Study of ALZT-OP1 in Subjects with Evidence of Early Alzheimer’s Disease. Protocol Number AZT-001

    This Phase III study is designed as a randomized, double-blinded, placebo-controlled study for subjects with evidence of early AD. Subjects will be randomly assigned to the Group I arm which will consist of ALZT-OP1a  (cromolyn) for inhalation, plus an oral placebo tablet; OR the Group II arm, which consists of ALZT-OP1 combination therapy ALZT-OP1a (cromolyn) for inhalation, plus ALZTOP1b (ibuprofen) tablet for oral administration; OR to the Group III arm, which will consist of inhaled placebo, plus ALZT-OP1b (ibuprofen) tablet for oral administration; OR to the Group IV placebo arm, which will consist of inhaled placebo plus an oral placebo tablet.

    This is a 72 week double-blind placebo controlled trial. Inclusion criteria includes: 55-79 years of age, Diagnosis of Mild Cognitive Impairment (MCI) positive Amyloid in Cerebral Fluid, and must have a reliable caregiver. Study medication is administered by inhaler 1 x per day. This is a multi-centered trial and is sponsored by the AZ Therapies Inc.

    For more information, click here

    Inclusion criteria includes: 55-79 years of age, Diagnosis of Mild Cognitive Impairment (MCI) positive Amyloid in Cerebral Fluid, and must have a reliable caregiver. 

    Rosanna Cirio, MA
    (914) 597-2476
    rcirio@burke.org

  • Dementia

    Jun 13, 2016 (ongoing)

    A Phase 3, multicenter, randomized, double-blind, placebo-controlled study to assess the efficacy, safety, and tolerability of AVP-786 (deuterated [d6]-dextromethorphan hydrobromide[d6-DM]/ quinidine sulfate [Q]) for the treatment of agitation in patients with dementia of the Alzheimer’s type

    The objectives of the study are to evaluate the efficacy, safety, and tolerability of AVP-786 compared to placebo, for the treatment of agitation in patients with dementia of the Alzheimer’s type.  The diagnosis of probable Alzheimer’s disease will be based on the ‘2011 Diagnostic Guidelines for Alzheimer’s Disease’ issued by the National Institute of Aging (NIA)-Alzheimer’s Association (AA) workgroups. Diagnosis of agitation will be based on the International Psychogeriatric Association (IPA) Agitation Definition.

    This is a 16 week double-blind placebo controlled trial. Inclusion criteria includes: 50-90 years of age, diagnosis of agitation must meet the IPA provisional definition of agitation, MMSE between 6 and 26, and must have a reliable caregiver. Study medication is administered by inhaler 1 x per day. This is a multi-centered trial and is sponsored by AVANIR PHARMACEUTICALS, INC.

    This is a 16 week double-blind placebo controlled trial. Inclusion criteria includes: 50-90 years of age, diagnosis of agitation must meet the IPA provisional definition of agitation, MMSE between 6 and 26, and must have a reliable caregiver. 

    Rosanna Cirio, MA
    (914) 597-2476
    rcirio@burke.org

  • Dementia

    Jun 13, 2016 (ongoing)

    Imaging Dementia—Evidence for Amyloid Scanning (IDEAS) Study: A Coverage with Evidence Development Longitudinal Cohort Study

    The purpose of the Imaging Dementia—Evidence for Amyloid Scanning (IDEAS) Study is to examine prospectively how the use of amyloid PET impacts the management and outcomes of patients with mild cognitive impairment (MCI) or dementia of unknown etiology. The Centers for Medicare & Medicaid Services (CMS) is providing coverage for the amyloid PET performed for this project under a program known as “coverage with evidence development” (CED).

    This is a 90 day study.  The Inclusion Criteria includes:  65 and older; Medicare beneficiary; Diagnosis of MCI or dementia verified by a dementia specialist within 24 months; The etiologic cause of cognitive impairment is uncertain after a comprehensive evaluation by a dementia specialist, including general medical and neurological examination, mental status testing including standard measures of cognitive impairment, laboratory testing, and structural neuroimaging. 

    The Inclusion Criteria includes:  65 and older; Medicare beneficiary, Diagnosis of MCI or dementia verified by a dementia specialist within 24 months; The etiologic cause of cognitive impairment is uncertain after a comprehensive evaluation by a dementia specialist, including general medical and neurological examination, mental status testing including standard measures of cognitive impairment, laboratory testing, and structural neuroimaging . 

    Rosanna Cirio, MA
    (914) 597-2476
    rcirio@burke.org

  • Traumatic Brain Injury

    Mar 31, 2016 (ongoing)

    Dietary Intervention in Traumatic Brain Injury and Concussion with the Modified Atkins Diet

    Concussions are still one of the most common injuries that can come as a result of playing a high-impact sports or activity. And while symptoms such as headache, dizziness and loss of concentration usually resolve themselves over time, a percentage of patients may experience persistent concussion syndrome (PCS), where they continue to experience these symptoms. 

    The goal of this trial is to determine whether eating a low-carb/high protein, high fat diet can help in concussion recovery. 

    Individuals who are at least 15 years old and who have experienced a concussion where symptoms have persisted for longer than 7 days may be eligible. 

    Carrie Quill at (914) 597-2191 or cquill@burke.org 

  • 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

  • Traumatic Brain Injury

    Mar 11, 2016 (ongoing)

    Phase 2 Study of the Safety and Efficacy of Modified Stem Cells (SB623) in Patients with Chronic Motor Deficit from Traumatic Brain Injury (TBI)

    The purpose of the study is to determine the safety and efficacy of a cell suspension of SB623 cells (modified stem cells derived from adult bone marrow) administered by injection into the patient’s brain around the area of the TBI. This is a one-time administration during a single surgery. 

    More information about this study, "A Double-Blind, Controlled Phase 2 Study of the Safety and Efficacy of Modified Stem Cells (SB623) in Patients with Chronic Motor Deficit from Traumatic Brain Injury (TBI)" can be found here

    Qualifying patients between the ages of 18-75 that have been diagnosed with a persistent motor deficit (e.g. arm or leg weakness) from traumatic brain injury (TBI) to the head at least 12 months ago, but not more than 36 months ago.

    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 

  • Dementia

    Sponsoring Agency: National Institute of aging (NIA) and the Alzheimer’s Disease Discovery Foundation (ADDF). | Apr 7, 2015 (ongoing)

    Benfotiamine in Alzheimer's Disease: A Pilot Study

    Burke Rehabilitation Hospital is currently conducting a clinical trial to evaluate whether increasing brain glucose utilization can slow cognitive decline in patients with Amnestic Mild Cognitive Impairment or mild Alzheimer's disease dementia.

    Thiamine (vitamin B1) is closely linked to glucose metabolism, which is important to maintain memory and cognition. Many thiamine dependent processes are diminished in Alzheimer’s disease and reduced glucose utilization is one of the early symptoms of the development of Alzheimer’s disease. The goal of this trial is to determine if increasing brain thiamine availability with the new investigational drug benfotiamine will minimize the decline in glucose utilization and slow the cognitive decline associated with Alzheimer’s disease.

    Individuals who are at least 60 years old and with a diagnosis of Amnestic Cognitive Impairment or Alzheimer's disease may be eligible for participation. During this study we will give you a complete neurological exam, conduct tests of memory, learning and other cognitive functions, draw blood for laboratory measures, and use imaging to examine the presence of amyloid (plaques) in your brain and also the amount of glucose that your brain is using.

    Study participation will be over a 12 month period and will include follow-up visits to our clinic every 3 months. There are no costs associated with participation in this study.

     Burke Rehabilitation Center is the designated location for this study.  If you would like more information regarding this study, please contact Rosanna Cirio, MA at 914-597-2476 or rcirio@burke.org.

    Gary E Gibson, Ph.D. and Barry D.  Jordan, M.D., MPH

    Rosanna Cirio, BS, MS  Burke Rehabilitation Hospital Co-Investigator

    Pasquale Fonzetti M.D. Burke Rehabilitation Hospital Co-Investigator

    Jessica Franchino-Elder Ph.D Winifred Masterson Burke Medical Research Institute  Co-Investigator

    Individuals who are at least 60 years old and with a diagnosis of Amnestic Cognitive Impairment or Alzheimer's disease may be eligible for participation. 

    Rosanna Cirio, MA, 914-597-2476 or rcirio@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

  • Spinal Cord

    Sponsoring Agency: Burke Foundation | Nov 1, 2013 (ongoing)

    Combined brain stimulation and hand robotic training in chronic SCI

    This study will investigate the effects of 2 weeks of daily hand robotic training plus direct current brain stimulation (tDCS) on the functional recovery of hand function. The mechanisms of motor recovery will be studied using transcranial magnetic stimulation (TMS). For more information, download our patient handout.

    Chronic spinal cord injury subjects with some motor deficit in the hands. 

    Mar Cortes, M.D. / Rebecca Woll
    (914) 368-3181
    sciclinicaltrials@burke.org

  • Tinnitus

    Jun 10, 2013 (ongoing)

    Pilot trial of non-invasive brain stimulation for tinnitus

    One percent of the population has treatment-resistant tinnitus, which can cause significant problems in daily living, such as psychological distress and insomnia. Repetitive transcranial magnetic stimulation of the brain's hearing area may reset sensory perception and reduce tinnitus.

    Douglas Labar, M.D., Ph.D.
    Dylan Edwards, Ph.D., P.T.
    Mar Cortes, M.D.

    Adults with treatment-resistant tinnitus for more than 6 month.

    Douglas Labar, M.D., Ph.D. 
    (212) 746-2359
    drlabar@med.cornell.edu 

  • 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: 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

  • Orthopedics

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

    Factors Predicting Outcome of Patients with Unilateral Total Knee Arthoplasty

    A prospective, observational study of the factors that influence recovery during in-patient rehabilitation of individuals who have unilateral total knee arthroplasty.

    Herbold, J
    Bonistall K
    Konjar T
    Coggins E
    Carr K
    Ronda-Velez Y
    Malcolmson L
    Shah B
    Babyar SR.

    Patients with first, unilateral total knee replacement arthroplasty.

    Janet Herbold, P.T., M.P.H.
    914-597-2357
    jherbold@burke.org

  • Traumatic Brain Injury

    Sponsoring Agency: NIH & James S. McDonnell Foundation | Sep 1, 2009 (ongoing)

    Neurophysiological studies of neurological disorders of consciousness

    Observational study of patients with severe brain injury from stroke or TBI who are not fully conscious to determine the underlying mechanisms of recovery of consciousness and if patients have residual levels of consciousness not detected on behavioral exam. Uses behavioral testing, EEG, MRI and PET brain imaging. All studies performed at NYP-Cornell Medical Center.

    Andrew Goldfine, M.D.
    Nicholas Schiff, M.D.

    Patients in vegetative and minimally conscious state after traumatic brain injury or stroke.

    Jennifer Hersh
    (646) 962-8032
    jeh2015@med.cornell.edu

Archived Projects

  • Spinal Cord

    Sponsoring Agency: NIH | Feb 1, 2009 - Sep 30, 2012

    Modulation of Spinal Excitability with Repetitive Paired TMS (Transcranial Magnetic Stimulation) and Peripheral Nerve Stimulation

    The purpose of this study is to investigate the changes in the excitability of spinalcord before and following a period of repetitive and synchronized dual peripheral nerve and brain stimulation.         

    Dylan J Edwards, PT, PhD

    Spinal cord injury subjects, >1 year after the injury

    Mar Cortes, MD
    (914) 368-3181
    clinicaltrials@burke.org

  • Traumatic Brain Injury

    Sponsoring Agency: Burke Foundation | Mar 1, 2010 - Apr 30, 2011

    Quantification of Unilateral Neglect

    This study will lead to developing a superior diagnostic tool for visuospatial neglect.

    Dylan J Edwards, PT, PhD
    Glen Prusky, PhD

    In-patients at Burke with visuo-spatial neglect (stroke, TBI)

    Dylan Edwards, PT, PhD
    (914) 368-3080

  • Spinal Cord

    Sponsoring Agency: NIH | Aug 1, 2010 - Oct 1, 2013

    Upper-extremity robotic training study in chronic SCI

    The purpose of this study is to investigate the mechanisms of the motor recovery in patients with chronic loss of function in the upper-limb after SCI, and to characterize the neurophysiological profile of patients and specific muscles that respond to robotic motor training by using Non-invasive brain stimulation, Transcranial Magnetic Stimulation (TMS). 

    Spinal cord injury subjects, with cervical lesions,  >1 year after the injury

  • 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

  • Spinal Cord

    Sponsoring Agency: NIH | Nov 1, 2011 - Jun 30, 2012

    Upper extremity motor cortex mapping in chronic thoracic SCI study

    This study investigates the motor cortex map representation of hand muscles in chronic spinal cord injury subjects with paraplegia (thoracic lesions).

    Dylan J Edwards, PT, PhD

    Spinal cord injury population with toracic lesions, paraplegics, >6 months after the injury

    Mar Cortes, MD; Robin Cash
    (914) 368-3181
    clinicaltrials@burke.org

  • Orthopedics

    Nov 7, 2011 - Jul 26, 2012

    Effectiveness of CPM Use in Inpatient Rehabilitation Hospital following Total Knee Replacement: A Prospective Randomized Control Trial

    The purpose of this study is to determine the effectiveness of the continuous passive motion (CPM) device in conjunction with standard exercises for TKA patients in post-acute rehabilitation in an Inpatient Rehabilitation Facility (IRF) when compared to standard therapy alone. 

    Janet A. Herbold, PT, MPH
    Suzanne Babyar, PT, PhD
    Kristen Bonistall, MS, MSW
    Banny Shah, PT
    Lisa Malcomson, PT

    Patients between the ages of 40 and 85 who underwent unilateral knee replacement due to osteoarthritis and who are admitted for continued in-patient rehabilitation at Burke Rehabilitation Hospital. The main inclusion criteria is an active flexion range of motion between 45 and 75 degrees.

    Janet Herbold, P.T., M.P.H.
    (914) 597-2357
    jherbold@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

    Sponsoring Agency: Burke Foundation | Mar 13, 2013 - Feb 22, 2016

    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

  • Spinal Cord

    Sponsoring Agency: NIH & Burke Foundation | Jul 1, 2013 - Aug 30, 2015

    Upper-extremity motor cortex TMS mapping in chronic SCI

    This study will investigate brain reorganization after an injury at the spinal cord level and its correlation with motor dysfunction.  Specifically, it will study the motor cortex representation of arm muscles in people with quadriplegia and paraplegia.

    Adults, age >18 years, with spinal cord injury and time since injury >6 months.

  • Spinal Cord

    Sponsoring Agency: NIH | Jul 1, 2013 - Aug 30, 2015

    Non-invasive stimulation for improving motor function in spinal cord injury

    The purpose of this study is to investigate the changes of the spinal cord excitability following a period of repetitive and synchronized dual peripheral nerve and non-invasive brain stimulation, and its correlation with enhanced motor function in lower limb.

    Spinal cord injury patients with time since injury > 6 months, and some degree of movement in the ankle muscles.

  • 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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