Clinical Research

Pioneering Rehabilitation

Clinical Research

Clinical research is 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.

Volunteers, also known as study subject are recruited for clinical trials. Their eligibility to participate in this type of research 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, 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.

Search Results

Viewing all current Clinical Studies:

  • 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
    Email:
    sciclinicaltrials@burke.org

  • 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 people with time since injury > 6 months, and some degree of movement in the ankle muscles.

    Mar Cortes, M.D.
    Phone: (914) 368-3181
    Email: sciclinicaltrials@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.

  • 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 psychological distress, insomnia, etc. Repetitive transcranial magnetic stimulation of the brain hearing area may reset sensory perception and reduce tinnitus.

    Douglas Labar, MD, PhD; Dylan Edwards, PhD; Mar Cortes, MD

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

    Dr. Labar, 212-746-2359

  • Multiple Sclerosis

    Sponsoring Agency: Sun Pharma | Feb 21, 2013 (ongoing)

    Placebo-Controlled Randomized Withdrawal Evaluation of the Efficacy and Safety of Baclofen ER Capsules (GRS) in Subjects with Spasticity Due to Multiple Sclerosis - CLR_09_21


    The purpose of this 26-week study is to evaluate the safety and efficacy of Baclofen, extended release capsules, in multiple sclerosis patients. 

    Multiple sclerosis patients, 18 years or older, on a stable dose of oral Baclofen, 30 to 60 mg, and have spasticisty in legs.

    Rosanna Cirio at (914) 597-2476

  • 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, MD, PhD and Andrew Goldfine, MD

    Patients with a first time stroke

    Andrew Goldfine, MD: (914) 597-2163 or ang9037@med.cornell.edu

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

    Carolin I Dohle, MD; Raj Ratan MD PhD

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

    Carolin Dohle, MD; 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.                            

    Dylan J Edwards, PT, PhD

    Chronic stroke

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

  • Dementia

    Sponsoring Agency: AVINAR Pharmaceuticals | Nov 30, 2011 (ongoing)

    PRISM,  "The Pseudobulbar affect registry series"

    The objective of the registry is to determine the prevalence of pseudobulbar
    affect (PBA) in patients with certain underlying neurologic conditions: Alzheimer’s Disease
    (AD), Amyotrophic Lateral Sclerosis (ALS), Multiple Sclerosis (MS), Parkinson’s Disease (PD),
    Stroke (STR), and Traumatic Brain Injury (TBI).

    Pasquale Fonzetti, M.D., Ph.D

    Individuals 18 years or older with Alzheimer’s Disease (AD), Amyotrophic Lateral Sclerosis (ALS), Multiple Sclerosis (MS), Parkinson’s Disease (PD), Stroke (STR), and Traumatic Brain Injury (TBI).

    Rosanna Cirio, M.A.

    914-597-2476

    rcirio@burke.org

  • Stroke

    Nov 10, 2011 (ongoing)

    Effect of Neuromuscular Electrical Stimulation to the Neck Muscles in Individuals with Stroke and Lateropulsion.

    A study of the possible effect of subthreshold neuromuscular stimulation of the neck muscles on lateropulsion ("pusher syndrome" following stroke.

    Babyar SR
    Reding M
    Matuszewski J
    Lasko L. 

    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, PT, PhD
    914-597-2839
    sbabyar@burke.org

  • Stroke

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

    The Interaction of Weight Shift on Scapulothoracic Movement of Individuals with Hemiparesis with and without Taping

    A study about the interaction of scapular movements during reaching, weight shift, and kinesiotape application of individuals with chronic stroke and healthy controls.

    Babyar SR
    Holland T
    O’Connor M
    Lagatutta J
    Gerkhardt L.

    Healthy controls over 60 year and patients with stroke who have undergone an active rehabilitation program, can walk independently with or without a cane and who can reach their affected arm to 90 degrees and who can stand for approximately 1 hour.  Participants must be free of allergies to medical or athletic tape

    Suzanne R. Babyar, PT, PhD
    914-597-2839
    sbabyar@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 J Edwards, PT, PhD
    Heidi Schambra, MD

    Chronic stroke

  • 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 PT, MPH
    914-597-2357
    jherbold@burke.org

  • Stroke

    Sponsoring Agency: BRH | Nov 8, 2011 (ongoing)

    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.

    Babyar, S.R.
    Edwards, D.
    Reding, M.

    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, PT, Ph.D.
    (914) 597-2839
    sbabyar@burke.org

  • Stroke

    Dec 1, 2009 (ongoing)

    Use of a wakefulness-promoting agent (armondafinil) combined with neuro-rehabilitation to improve neurological recovery and to reduce the incidence of disability in patients who suffered a stroke

    This study is investigating whether intensive neurorehabilitative training and treatment with armodafinil can improve upper and lower motor coordination and strength. This study is investigating whether intensive neurorehabilitative training and treatment with armodafinil can improve upper and lower motor coordination and strength.

    Pasquale Fonzetti, M.D., Ph.D.

    This study includes stroke patients with a recent, first-time ischemic or hemorrhagic stroke (within the last 3 weeks) who have moderate to severe motor impairment (combined Fugl-Meyer score > 25).  Other criteria for participation may apply.

    Diana Zondorak, M.A
    914-597-2827
    dzondorak@burke.org

  • Stroke & 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, MD
    Nicholas Schiff, MD

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

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

  • Stroke

    Sponsoring Agency: NIH | Feb 1, 2006 (ongoing)

    IRIS: Insulin resistance intervention after stroke or TIA

    This study is attempting to prevent recurrent stroke, heart attack, and diabetes by controlling insulin resistance after stroke.

    Pasquale Fonzetti, MD, PhD

    This study includes non-diabetic stroke patients with a recent ischemic stroke (within the last 6 months) who are determined to be insulin resistant by a screening blood test.  Other criteria for participation may apply.

     Diana Zondorak, M.A.

    dzondorak@burke.org

    914-597-2827

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

  • Stroke & 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 caracterize the physiology of the recovery. 

    Carolin Dohle, MD
    Dylan Edwards, PT, PhD

    Subacute stroke patients

    Carolin Dohle, MD - 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, PT, MPH
    914-597-2357
    jherbold@burke.org