CLINICAL TRIALS

CLINICAL TRIALS by CONDITION

Please find trials at MNRH listed by the following conditions:

  • STROKE
  • SPINAL CORD INJURY
  • TRAUMATIC BRAIN INJURY
  • NON-REHABILITATION TRIALS

STROKE

Title: Center for Brain Plasticity

Sponsor:  Georgetown University / MedStar Health Partnership

PI: Dromerick, Alexander            

Purpose:  The Center will focus on the study of neuroplasticity, the biological process underlying the brain’s ability to learn and develop, and a potential recovery tool in conditions such as stroke, traumatic brain injury, multiple sclerosis, and dementias such as Alzheimer’s. The Center’s long-term aim is to stimulate the brain to recover from damage, preserving and restoring neurologic function.

Title: Stroke National Capital Area Network for Research (SCANR)

Sponsor:  NIH/NINDS

PI: Dromerick, Alexander            

Purpose:  The goal of this project is the combination of five hospitals in the area that join strong multidisciplinary clinical and research expertise in stroke research while capturing nearly all stroke patients in the area for trials ranging from acute intervention to rehabilitation and provide outstanding training and mentorship for stoke clinician fellows that will prepare them for productive stroke research careers.

Title:  A Double-Blind, Controlled Phase 2B Study of the Safety and Efficacy of Modified Stem Cells (SB623) in Patients with Chronic Motor Deficit from Ischemic Stroke.

Sponsor: San Bio/Sanovian Pharmaceuticals  (Commercial)

PI:  Zorowitz, Richard

Purpose: To evaluate the clinical effectiveness of the SB623 Modified Stem Cell on motor outcomes of stroke survivors with Ischemic-type lesions.  Motor assessments will include the following: Modified Ranken Scores; Action Research Arm Test; and Gait Velocity.

Title: Critical Periods after Stroke Study (C-PASS)

Sponsor: Intramural Funding

PI: Dromerick, Alexander

Purpose: There is rodent evidence for timing effects in rehabilitation; motor training delivered at certain times may be more effective.  If analogous critical/sensitive periods can be identified after human stroke, then existing clinical resources can be better utilized to promote recovery.  The Critical Periods after Stroke Study (CPASS) is a phase IIA randomized, controlled trial designed to explore whether such a sensitive period exists.  In this study we are randomizing 64 persons to receive an additional bolus of 20 hours of upper extremity therapy either immediately upon rehab admission, at 2-3 months after stroke onset, at 6 months after onset, or to an observation-only control group.

Title: Hand Exoskeleton Rehabilitation Robot (HEXORR)

Sponsor: NIH

PI: Lum, Peter

Purpose: Evaluate the effectiveness of the HEXORR device in remediating motor impairment of the hand in chronic stroke survivors.

Title: Biomimetic Hand Exotendon Device (BiomHED) for restoration of hand function post-stroke

Sponsor: NIH

PI: Lee, Sang Wook

Purpose:  Develop a biomimetic hand exoskeleton device that enables functional movements of the hand for stroke survivors.  In addition, the study is interested in assessing the efficacy of a ‘subject-specific’ training that provides ‘targeted assistance’ to the impaired muscle-tendons of stroke survivors.

Title: Task-specific upper-extremity robotic training for stroke neurorehabilitation

Sponsor: US Veterans Affairs Merit Award

PI: Lum, Peter                                                  

Purpose: The goal of the project is to develop a robotic device capable of treating upper-extremity movement impairments resulting from stroke.  The developed device will assist in the training of tasks involving reach and grasp of physical objects requiring varying grasp patterns.

Title: Impact of Right – Hemisphere Stroke on Functional Performance and Brain Organization

Sponsor: Georgetown – Howard Universities Center for Clinical & Translational Science – KL2 Award

PI: Greenwald, Anna

Purpose: This study will define the functional reorganization that occurs after right hemisphere stroke, with the goal of refining assessment tools, improving the detection of specific deficits, and informing the development of targeted interventions that enhance adaptive, and prevent maladaptive, reorganization.

Title: Biomarkers of Stroke Recovery (BIOREC)

Sponsor: Intramural Funding

PI: Edwardson, Mathew

Purpose: The study is interested in aim measuring the molecular changes that occur in the peripheral blood during the recovery phase following stroke.  The study will form the basis for a larger single-center trial demonstrating specific molecular changes that occur in those with favorable and unfavorable recovery.

Title:  Shoulder and Hand Function Improvement Post Stroke (SHIPS)

Sponsor:  Greenberg Research Fellowship

PI:  Geed, Shashwati

Purpose: This study is interested in determining whether different shoulder positions or muscle activations influence the brain’s control over hand muscles differently in individuals who have suffered a stroke compared to healthy individuals.  In addition, the study will assist investigators understand why certain atypical movement patterns appear in individuals with stroke.

Title: Advanced Rehabilitation Research Training Program in Neurorehabilitation

Sponsor:  US Department of Education

PI: Bregman, Barbara    

Purpose:  A main focus of our training mission is to provide the strongest possible education for the early career development of neuroscience rehabilitation researchers in an educational environment that promotes strong interactions between basic and clinical research to develop effective interventions to promote functional recovery after CNS injuries, such as brain and spinal cord trauma, stroke.  The long range goal of this training program is to prepare individuals with advanced rehabilitation related degrees (physicians: physiatrists, neurologists, neurosurgeons and PhD trained physical and occupational therapists) who will be in a position to define the mechanisms underlying recovery of function following CNS injury, to identify and implement methods to enhance that recovery, and to influence health policy to benefit individuals with disabilities.  This application brings together basic and clinician scientists at two outstanding institutions in Washington, DC (Georgetown University and the National Rehabilitation Hospital (NRH).

Title: Cortical Plasticity Associated with Speech Aphasia

Sponsor:  Doris Duke Foundation

PI: Turkletaub, Peter

Purpose:  Focused on understanding the varying neurological mechanisms associated with brain plasticity after stroke and its impact on speech recovery.

SPINAL CORD INJURY

Title: The Impact of Self-Management with Probiotics on Urinary Symptoms and the Urine Microbiome in Individuals with Spinal Cord Injury (SCI) and Spina Bifida (SB).
Sponsor: Patient-Centered Outcomes Research Institute (PCORI)

 

PI: Groah, Suzanne        

Purpose: The study is interested in exploring the use of probiotics to manage urinary symptoms of individuals with Spinal Cord Injury & Spina Bifida.

Title: Development of a Urinary Symptoms Questionnaire People with Neuropathic Bladder – Indwelling Catheters

Sponsor: Craig H Neilsen Foundation

PI: Groah, Suzanne        

Purpose: To develop an instrument, the Urinary Symptom Questionnaire for individuals with neurogenic bladder due to spinal cord injury (SCI) who utilize indwelling urethral or suprapubic catheters (IUSC) and then explore the use of that instrument to enhance the diagnostic approach to urinary tract infection (UTI) in this population.

Title: Development of a Urinary Symptoms Questionnaire People with Neuropathic Bladder – Indwelling Catheters

Sponsor: The National Institute on Disability, Independent Living, and Rehabilitation Research

PI: Groah, Suzanne        

Purpose: To develop an instrument, the Urinary Symptom Questionnaire for individuals with neurogenic bladder due to spinal cord injury (SCI) who utilize indwelling urethral or suprapubic catheters (IUSC) and then explore the use of that instrument to enhance the diagnostic approach to urinary tract infection (UTI) in this population.

TRAUMATIC BRAIN INJURY

Title:  A double-blind, randomized, sham-controlled study of the safety and effectiveness of the Portable Neuromodulation Stimulator (PoNS™) 4.0 device for cranial nerve noninvasive neuromodulation (CN-NINM) training in subjects with a chronic balance deficit due to mild-to-moderate traumatic brain injury (TBI)

Sponsor: NeuroHabilitation, Inc.

PI: Yochelson, Michael

Purpose:  To evaluate the effectiveness of cranial nerve noninvasive neuromodulation (CN-NINM) training on balance, using the PoNS 4.0 device with normal stimulation (active) versus the PoNS 4.0 device with low, perceivable stimulation that is intended to be ineffective (sham control), in subjects with a chronic balance deficit due to mild-to-moderate TBI.

Title: BrainForce: A Screening Test for Concussion

Sponsor: MedStar Institute for Innovation

PI: Dromerick, Alexander; Lum, Peter; Tractenberg, Rochelle; Garmoe, William

Purpose:  This study will evaluate techniques of screening individuals with suspected mild traumatic brain injury (i.e. concussion).  The study will support the future development of technology that can easily & appropriately screen patients with suspected concussion either in clinical settings or in the community.

NON-REHABILITATION TRIALS

Acute

Title: Stroke Hyperglycemia Insulin Network Effort (SHINE) Trial

Sponsor: NIH/NINDS

PI: Benson, Richard

Purpose:  The Stroke Hyperglycemia Insulin Network Effort (SHINE) Trial is a multicenter, randomized, controlled clinical trial of 1400 patients that will include approximately 60 enrolling sites. The study hypotheses are that treatment of hyperglycemic acute ischemic stroke patients with targeted glucose concentration (80mg/dL - 130 mg/dL) will be safe and result in improved 3 month outcome after stroke.

 
Title: DEFUSE 3: Endovascular Therapy Following Imaging Evaluation for Ischemic Stroke

Sponsor: NIH/NINDS

PI: Hsia, Amie

Purpose: This is a study to evaluate the hypothesis that FDA cleared thrombectomy devices plus medical management leads to superior clinical outcomes in acute ischemic stroke patients at 90 days when compared to medical management alone in appropriately selected subjects with the Target mismatch profile and an MCA (M1 segment) or ICA occlusion who can be randomized and have endovascular treatment initiated between 6-16 hours after last seen well.

Title: CREST2: Carotid Revascularization and Medical Management for Asymptomatic Carotid Stenosis

Sponsor: NIH/NINDS

PI: Woo, Edward

Purpose: Carotid revascularization for primary prevention of stroke (CREST-2) is two independent multicenter, randomized controlled trials of carotid revascularization and intensive medical management versus medical management alone in patients with asymptomatic high-grade carotid stenosis. One trial will randomize patients in a 1:1 ratio to endarterectomy versus no endarterectomy and another will randomize patients in a 1:1 ratio to carotid stenting with embolic protection versus no stenting. Medical management will be uniform for all randomized treatment groups and will be centrally directed.