CLINICAL RESEARCH AND TRIALS

CLINICAL TRIALS by CONDITION

Please find trials at MNRH listed by the following conditions:

  • STROKE
  • SPINAL CORD INJURY
  • TRAUMATIC BRAIN INJURY
  • OTHER RESEARCH 

STROKE

Stem Cell Study 

 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

Purpose: This study will evaluate the clinical effectiveness of the SB623 Modified Stem Cell on motor outcomes of stroke survivors with ischemic-type lesions. To learn more

Upper Extremity Studies

Critical Periods after Stroke Study (CPASS)

Purpose: There is rodent evidence for timing effects in rehabilitation; motor training delivered at certain times may be more effective.  If analogous critical periods can be identified after human stroke, then existing clinical resources can be better utilized to promote recovery.  To learn more

Shoulder and Hand Function Improvement Post Stroke (SHIPS)

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. To learn more 

A Phase 2a, Randomized, Double-Blind, Placebo-Controlled 21 Day Treatment Study, Including an fMRI Sub-study, to Evaluate the Effect of HT-3951 on Upper Extremity Motor Function Following Ischemic Stroke

Purpose: This outpatient study that will utilize standard stroke rehabilitation outcome measures to evaluate the effect of the monoamine oxidase Type B (MAO-B) inhibitor, HT-3951, on motor recovery and behavior in medically stable subjects following ischemic stroke. To learn more

Stimulation to improve movement 

Purpose: This trial involves a painless, non-invasive, investigational test of brain function called transcranial magnetic stimulation (TMS). To learn more

Hand Exoskeleton Rehabilitation Robot (HEXORR)

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

Home Therapy for Stroke Rehabilitation Using the HandSOME Exoskeleton (HandSOME)

Purpose: HandSOME is a lightweight wearable hand orthosis that increases range of motion and decreases effort during grasping tasks. The goal of this study is to evaluate the HandSOME device's effectiveness in the rehabilitation of stroke patients through an 8-week intervention.  To learn more

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

Purpose: The goal of this study is to 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.   To learn more

Task-specific upper-extremity robotic training for stroke neurorehabilitation

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. To learn more

Biomarker Study

Biomarkers of Stroke Recovery (BIOREC)

Purpose: This longitudinal observational study seeks to identify molecular markers of brain repair in the blood that signal why some stroke patients have good recovery of arm function while others have poor recovery. To learn more

Cognition After Stroke Studies

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

Purpose: This study uses cognitive testing, functional MRI, and disability assessments to investigate how brain function and organization are altered by right-hemisphere stroke, and how these changes relate to long-term recovery. To learn more

Aphasia Studies

Purpose:  These studies focus on understanding the varying neurological mechanisms associated with brain plasticity after stroke and its impact on speech recovery. To learn more

PORSCHE – A Prospective multi-center study comparing the performance if the dysphasia detection system (DDS) in detecting impaired Swallowing safety and efficiency as Compared to the clinical reference method – videofluorosopic swallowing study (VFSS) 

Purpose: To show whether a new investigational device is safe and works for identifying swallowing impairment. To learn more. 

SPINAL CORD INJURY

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)

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

Fitness and Independence after SCI: Defining Meaningful Change and Thresholds

Purpose: This project will determine how much the fitness of an individual living with SCI/D must increase to support a meaningful gain in independence. To learn more

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

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. To learn more

 

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.

other research 

Stroke Central Atlantic Network for Research (SCANR)

Acute Studies

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.

PEDIATRIC STROKE RESEARCH 

A large part of our research portfolio involves children who have had a stroke around the time of birth. For more information, please click here. For information on research participation, please click here.