Completed Research Studies

1. Title: Value of Magnetic Resonance Imaging (MRI) and Diffusion Tensor Imaging (DTI) as Biomarkers for Classifying Acute Spinal Cord Injury

Purpose: The purpose of this project is to develop a novel objective method to assess the extent of neurologic damage in acute spinal cord injury (SCI) utilizing advanced MR imaging techniques. The neurologic exam at presentation (AIS), conventional MRI feature designators of lesion length and location, and additional MRI metrics provided by diffusion tensor imaging (DTI) will be assessed to determine which variables or combination of variables best predicts clinical outcome, as defined by neurological examinations at 1 week, 2 weeks, 3 months and 6 months.

Principal Investigator: Adam E. Flanders, MD
Co-Investigator(s): Ralph J. Marino, MD; Christina V. Oleson, MD


2. Title: Safety and Pharmacokinetics of Riluzole in Patients with Acute Traumatic Spinal Cord Injury

Purpose: The primary aim of this study is to develop acute care safety and pharmacokinetic profiles of Riluzole in patients who have sustained a traumatic spinal cord injury. Secondary objectives are to conduct exploratory analyses of functional outcomes for purposes of planning a subsequent Phase II b - Phase III randomized study of the efficiency of Riluzole for the treatment of acute spinal cord injury.

Principal Investigator: James S. Harrop, MD
Co-Investigator(s): Ralph J. Marino, MD


3. Title: Effects of Two Functional Electrical Stimulation (FES) Cycling Paradigms

Purpose:The overall purpose of this study is to compare the musculoskeletal and cardiovascular effects of a 6 month program of cycling with functional electrical stimulation (FES) using a low cadence and high resistance to the musculoskeletal and cardiovascular effects of cycling with functional electrical stimulation (FES) using a high cadence, low resistance program for people with spinal cord injury

Principal Investigator: Therese Johnston, PT, Ph.D., MDA
Co-Investigator(s): Ralph J. Marino, MD; Mary Schmidt-Read, DPT; Richard Lauer, Ph.D.; Christopher Modlesky, Ph.D.


4. Title: Development and Validation of the Thoracic-Lumbar Control Scale to Measure Strength and Coordination of Trunk Muscles

Purpose:The purpose of this study is to develop a clinical scale for measuring the strength of trunk musculature. These are the muscles that help balance and hold your body in good posture.

Principal Investigator: Ralph J. Marino, MD
Co-Investigator(s): Mary Schmidt-Read, MS, PT


5. Title: UAB Index of Motor Recover: Validation of an Outcome Measure for Motor Recovery in Incomplete Spinal Cord Injury

Purpose:The purpose of this study is to evaluate a muscle testing measurement tool to look for any voluntary action of a lower extremity muscle group following spinal cord injury.

Principal Investigator: Ralph J. Marino, MD
Co-Investigator(s): Mary Schmidt-Read, MS, PT


6. Title: Investigation of Assistive Technology for Mobility used by Individuals with a Spinal Cord Injury

Purpose:The objectives of this study are first, to investigate the impact of policy changes on customizability and features of wheelchairs and the number of working wheelchairs an individual owns (component 1), and secondly to investigate distance traveled, time spent active, and speed traveled in a power and/or manual wheelchair and its relationship to wheelchair provided, wheelchair breakdown, quality of life and wheelchair skills (component 2).

Principal Investigator:Ralph J. Marino, MD
Co-Investigator(s): Mary Schmidt-Read, MS, PT; Mary Patrick, RN, MSN


7. Title: Development of the Capabilities of Upper Extremity Test (CUE-T)

Purpose:The specific aim of this on-site research project is to develop an objective, standardized test of upper limb function in tetraplegia called the Capabilities of Upper Extremity Test (CUE-T) based on the items in the CUE.

Principal Investigator:Ralph J. Marino, MD
Co-Investigator(s): Stephen Kern, OT, Ph.D.; Mary Patrick, RN, MSN


8. Title: A 17-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multicenter Trial of Pregabalin for the Treatment of Chronic Central Neuropathic Pain after Spinal Cord Injury

Purpose:The main purpose of this study is to evaluate if pregabalin relieves nerve pain associated with spinal cord injury. This study aims to repeat the data on the effectiveness of pregabalin that was shown in the previous study. In addition, this study will also evaluate any side effects and whether or not they might be related to pregabalin. Lastly, this study will also assess whether subjects will experience improvement in sleep, general health, and on symptoms of anxiety and depression.

Principal Investigator:Ralph J. Marino, MD
Co-Investigator(s): Christopher S. Formal, MD


9. Title: Peripheral Denervation Following Spinal Cord Injury

Purpose:The purpose of this study is to evaluate the use of special MRI techniques to study how healthy the nerves are in the paralyzed muscles below a spinal cord injury. Also, to identify which muscles are abnormal and how severely the nerves are affected. The information obtained will be important to know in order to maximize the beneficial effects of future treatments.

Principal Investigator:Anthony S. Burns, MD
Co-Investigator(s):Ralph J. Marino, MD


10. Title: A Phase II, Double-Blind, Placebo-Controlled, Multicenter Study to Assess the Efficacy and Safety of HP184 at 100, 200, and 400 mg Doses Administered Orally Once Daily for Twenty-Four Weeks in Adult Subjects with Chronic Spinal Cord Injury (CSCI)

Purpose:The purpose of this study is to evaluate the effect of HP184 as compared to placebo on improvements of muscle strength in subjects with motor incomplete spinal cord injury. The study will also help us determine the safety and tolerability of HP184 when administered for 24 weeks in subjects with chronic spinal cord injury as well as the effect of HP184 on the walking function and spasticity.

Principal Investigator:Ralph J. Marino, MD
Co-Investigator(s): Anthony S. Burns, MD


11. Title: A Phase I/IIa Dose-Ranging Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of BA-210 and the Neurological Status of Patients Following Administration of a Single Extradural Application of Cethrin® During Surgery for Acute Thoracic and Cervical Spinal Cord Injury

Purpose:The primary goal of this study is to determine the safety and tolerability of BA-210 when administered in conjunction with fibrin sealant to the dura mater of the spinal cord during surgery. A second goal is to determine if BA-210 improves neurological function.

Principal Investigator:James S. Harrop, MD
Co-Investigator(s): Ashwini D. Sharan, MD, Alexander R. Vaccaro, MD, Ralph J. Marino, MD


12. Title: A Multi-Site, Open Label Study to Evaluate 250 mg Oral Neotrofin BID in Patients with Subacute Complete Spinal Cord Injury over 12 Weeks

Purpose:The purpose of this study is to evaluate the safety and efficacy of the experimental medication Neotrofin in patients with subacute complete spinal cord injury.

Principal Investigator: Anthony S. Burns, MD


13. Title: Predictive Value of Light Touch in Patients with Initial Motor Complete and Sensory Incomplete SCI

Purpose:To determine whether the pinprick test could be used as a prognostic indicator in persons with motor complete and sensory incomplete spinal cord injury.

Principal Investigator: Anthony S. Burns, MD


14. Title: Role of Hand Dominance in Recovery from Cervical SCI

Purpose:To determine the relationship between hand dominance and motor recovery in incomplete cervical spinal cord injury (SCI).

Principal Investigator: Anthony S. Burns, MD


15. Title: Restoration of Walking After Spinal Cord Injury: A Consumer Preference for Walking – Experiment 4

Purpose:To demonstrate consumer preference for restoration of walking function based on the severity of injury, time from injury (acutely injured versus those living with SCI over time) and age of the individual. Also, to compare consumer preferences with clinician preferences.

Principal Investigator: Mary Patrick, RN, MSN


16. Title: Restoration of Walking After Spinal Cord Injury: Demonstrate the WISCI Scale is More Responsive to Change than Other Outcome Measures in the Demonstration of Efficacy of Interventions such as Physical Training in Clinical Trials – Experiment 3

Purpose:The purpose of this trial is to determine whether the WISCI scale is more responsive to change than other outcome measures in the demonstration of efficacy of interventions such as physical training in clinical trials.

Principal Investigator: John F. Ditunno, MD
Co-Investigator(s): Michael F. Saulino, MD, Ph.D.


17. Title: Restoration of Walking After Spinal Cord Injury: An Experiment to Determine Whether a Disability Measure can be Developed by Incorporating Elements of Distance, Speed, and Endurance into the Appropriate Levels of the Walking Index for Spinal Cord Injury - Experiment 2

Purpose:The purpose of this study is to develop a disability measure for walking by incorporating elements of distance, speed and endurance into the appropriate levels of the Walking Index for Spinal Cord Injury (WISIC) scale.

Principal Investigator: John F. Ditunno, MD
Co-Investigator(s): Anthony S. Burns, MD


18. Title: Restoration of Walking after Spinal Cord Injury: Validation of the Walking Index for Spinal Cord Injury (WISCI 1) Scale for Hierarchial Ranking – Experiment 1

Purpose:The purpose of this study is to determine whether the WISCI scale is valid and responsive to change in a clinical population of individuals during recovery from spinal cord injury and will follow a hierarchial ranking validated by experts in SCI. Also, to determine whether changes in lower extremity muscle strength correlates with the progression of walking recovery measured on the 20 level WISCI scale.

Principal Investigator: John F. Ditunno, MD
Co-Investigator(s): Anthony S. Burns, MD


19. Title: Physiologic Measures of Improvement Following SCI Interventions, a Basic Science Research Project

Purpose:The primary goal of this research project is to investigate changes in lower motor neuron physiology following thoracic spinal cord injury (SCI).

Principal Investigator: Anthony S. Burns, MD
Co-Investigator(s): Alan R. Tessler, MD


20. Title: Open-Label Extension of Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate Safety, Tolerability and Activity of Oral Famipridine-SR in Subjects with Chronic Incomplete Spinal Cord Injury: An Extension Study to Evaluate the Safety of Oral Fampridine-SR in Persons with Chronic Spinal Cord Injury

Purpose:The purpose of this study is to examine the continued effects of Fampridine-SR on bodily functions such as spasticity, bladder control, bowel function and sexual function in people who have participated in a study using either Fampridine-SR or placebo in the past. The study will also examine the possible long-term risks of taking Fampridine-SR.

Principal Investigator: Ralph J. Marino, MD
Co-Investigator(s): Ramadevi Swaminath, MD, Bryan J. O’Neill, MD


21. Title: A Randomized Trial of Locomotor Training for SCI: A Study to Improve Walking after Spinal Cord Injury

Study the effects of Body Weight Supported Treadmill Training in acute incomplete spinal cord injury

Purpose:This project is designed to determine the effects of body weight supported treadmill training (BWSTT) on recovery of walking ability after traumatic incomplete spinal cord injury.

Principal Investigator: John F. Ditunno, MD
Co-Investigator(s): Michael F. Saulino, MD, Ph.D.



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