CRITERIA FOR PEOPLE WITH SPINAL CORD INJURY
These studies are recruiting people within the first day or two after injury
SYSTEMIC HYPOTHERMIA IN ACUTE CERVICAL SPINAL CORD INJURY
Purpose This clinical trial investigates the use of intravascular hypothermia to improve neurological outcomes in acute cervical spinal cord injury patients. By potentially reducing dependence on caretakers and increasing patient productivity, this approach could benefit both patients and society.
Qualification Summary This study is for adults 18-70 with a moderate or severe spinal cord injury (AIS A-C) from a non-penetrating blow, who can receive cooling treatment within 24 hours. It excludes people with very severe injuries, pre-existing health conditions, or who are pregnant. (contact for more information).
Status Enrolling
Principal Investigator Allan D. Levi, M.D., Ph.D.
Contact George Jimsheleishvili, M.D.
Website ClinicalTrials.gov
SPINAL CORD INJURY REGISTRY (NORTH AMERICAN CLINICAL TRIALS NETWORK)
Summary The North American Clinical Trials Network (NACTN) Spinal Cord Injury Registry aims to understand the natural course of recovery and complications in newly injured patients by collecting one-year follow-up data. This information will help design future clinical trials by identifying high-risk periods and expected recovery patterns.
Qualification Summary This study is for men or women 18 or older with a new traumatic spinal cord injury causing paralysis, weakness, or numbness, who haven’t received prior medical care for this injury at a specific type of hospital and can consent to participate. (contact for more information)
Status Enrolling
Principal Investigator James D. Guest, M.D., Ph.D.
Contact George Jimsheleishvili, M.D.
Website ClinicalTrials.gov
This study is recruiting people who have been recently discharged from inpatient rehab (within 2 months)
STAKEHOLDER PERCEPTIONS AND CLINICAL ASSESSMENT OF CARDIOMETABOLIC DISEASE/SYNDROME AFTER SPINAL CORD INJURY
Purpose This study investigates whether individuals with spinal cord injury (SCI) are aware of their risk for heart disease, diabetes, and other health problems, and how these risks change over two years post-injury. Researchers will compare participants’ self-reported awareness with actual measurements of their risk factors.
Qualification Summary Motor complete or incomplete, C5-L1, traumatic spinal injury; 18 – 70 years old; within 2 months of discharge from initial rehabilitation post-injury. (contact for more information)
Status Enrolling
Principal Investigator Mark S. Nash, Ph.D.
Contact Katherine Martinez
These studies are recruiting people with a spinal cord injury, regardless of date of injury
MALE FERTILITY EVALUATIONS
Purpose To determine the cause of low sperm motility in men with SCI.
Qualification Summary Adult men with spinal cord injury. (contact for more information)
Status Enrolling
Principal Investigator Emad Ibrahim, M.D.
Contact Orrey Padilla
EFFECTS OF BODILY ILLUSION AND tDCS ON SCI-RELATED NEUROPATHIC PAIN
Purpose To determine to what extent neuropathic pain following spinal cord injury (SCI) is reduced after a non-pharmacological treatment involving bodily illusion (BI) and transcranial Direct Current Stimulation (tDCS).
Qualification Summary This study seeks men and women aged 18-70 with incomplete spinal cord injuries in the neck (cervical) region and chronic pain lasting at least 3 months (moderate or worse, rated 4 or higher on a 0-10 scale). (contact for more information)
Status Enrolling
Principal Investigator Eva Widerstrom-Noga, Ph.D.
Contact Roberta Vastano, Ph.D.
BODY COMPOSITION, POSTPRADNIAL FAT METABOLISM AND PAIN IN SPINAL CORD INJURY
Purpose To study relationships between body composition (e.g., percent body fat), chronic pain, and measures of inflammation in blood in individuals with chronic spinal cord injury (SCI).
Qualification summary Age 18-65 years; SCI occurring at least 2 years prior to study entry; neurological level of injury (LOI) between C4 and L2; American Spinal Injury Association Impairment Scale (AIS) A-D. (contact for more information)
Status Enrolling
Principal Investigator Elizabeth Felix, Ph.D.
Contact Lais Vidotto
NERVE TRANSFER FOR RESTORING UPPER EXTREMITY MOTOR FUNCTION AFTER TETRAPLEGIA
Purpose The purpose of the study is to investigate the effectiveness of nerve transfer surgery in improving hand function for spinal cord injury patients. The study will assess hand strength, range of motion, and other factors to determine if the surgery offers functional benefits.
Qualification Summary This study is for people 18-65 with chronic tetraplegia who haven’t improved in 3 months and meet specific muscle function criteria. It excludes people with active infections, ongoing recovery, certain medical conditions, and other specifics. (contact for more information)
Status Enrolling
Principal Investigator S. Shelby Burks, M.D.
Contact George Jimsheleishvili, M.D.
SELF-REPORT ACCURACY OF THE ASIA CLASSIFICATION EXAM IN SCI
Purpose This study aims to compare how people with spinal cord injuries perceive their own level of function compared to how doctors assess it through a standardized exam. Researchers will ask participants about their injury and then conduct a detailed physical examination to measure nerve damage.
Qualification Summary Adults with a spinal cord injury or disease from any cause. (contact for more information)
Status Enrolling
Principal Investigator W. Dalton Dietrich, Ph.D.
Contact Nilanjana Datta, M.D.
TRANSFORMATIVE POTENTIAL OF ADAPTED OCEAN ACTIVITIES
Purpose This study aims to investigate the impact of open water activities (sailing, paddling, etc.) on health and wellbeing in disabled adults. Researchers will use surveys to assess self-reported changes in quality of life, self-efficacy, and other health domains following participation in these activities.
Qualification Summary Adults with disability who have participated at least one time in one of the adapted ocean activities being studied. (contact for more information)
Status Enrolling
Principal Investigator David W. McMillan, Ph.D.
Contact David W. McMillan, Ph.D.
ACCURACY OF SELF-REPORT WEIGHT AND HEIGHT IN PEOPLE WITH SCI
Purpose This study investigates the accuracy of self-reported weight and height in people with spinal cord injury. Researchers will compare self-reported measures with direct measurements and analyze how factors like time since last measurement and injury severity influence the accuracy of self-reporting.
Qualification Summary Adults with spinal cord injury or disease from any cause. (contact for more information)
Status Enrolling
Principal Investigator David W. McMillan, Ph.D.
Contact Nilanjana Datta, M.D.
These studies are recruiting people who were injured at least one year ago
CUNEIFORM NUCLEUS DEEP BRAIN STIMULATION FOR GAIT FACILITATION FOLLOWING SCI
Purpose This study aims to investigate the effectiveness of deep brain stimulation (DBS) of the cuneiform nucleus in improving walking ability and other functions for people with incomplete spinal cord injury. Researchers will implant electrodes in 6 participants and assess changes in gait speed, endurance, and quality of life.
Qualification Summary This study is for people with incomplete spinal cord injury (walking difficulties but some leg movement) who are at least 1-year post-injury, mentally sound, and able to commit to a 6-month training program. It excludes people with severe depression, cognitive impairment, substance abuse, certain medical conditions, or pregnancy. (contact for more information)
Status Approved, not yet recruiting
Principal Investigator Brian R. Noga, Ph.D. and Jonathan R. Jagid, M.D.
Contact: Letitia Fisher
EQUITY AND QUALITY IN ASSISTIVE TECHNOLOGY (EQUATE)
Purpose To study the assistive technology used by individuals with spinal cord injury (SCI) and those with diagnoses that affect the spinal cord.
Qualification Summary This study is for adults (18+) with a spinal cord injury (affecting movement or sensation) from at least a year ago, who can understand English and have internet access to participate. (contact for more information)
Status Enrolling
Principal Investigator: Elizabeth R. Felix, Ph.D.
Contact Matthew DeVlieger
ASSOCIATION OF SCI PHYSICAL ACTIVITY GUIDELINES AND HEALTH OUTCOMES
Purpose To understand whether meeting the spinal cord injury physical activity guidelines is associated with positive health-related outcomes.
Qualification Summary Adults with chronic spinal cord injury. (contact for more information)
Status Enrolling
Principal Investigator Elizabeth R. Felix, Ph.D.
Contact: Katherine Martinez
SPINAL CORD INJURY EXERCISE AND NUTRITION CONCEPTUAL ENGAGEMENT (SCIENCE)
Purpose The goal of this study is to assess the impact of home-based functional electrical stimulation leg cycle ergometry plus diet versus diet alone on body composition, insulin sensitivity, glucose effectiveness, and basal metabolic rate, as well as lower extremity bone mineral density, lipid profiles, and inflammatory markers in people with SCI. Participants will be randomized to either diet only or diet and exercise.
Qualification Summary This study seeks adults (18-65 years old) with complete motor loss (AIS A, B, C) due to a C4-T4 spinal cord injury that occurred at least one year ago. (contact for more information)
Status Concluding recruitment
Principal Investigator Gary J. Farkas, Ph.D.
Contact Dinorah Rodriguez
DIET AND RMR
Purpose The purpose of this study is to determine the relationship between nutritional needs, metabolic health, and body composition of individuals with and without spinal cord injury. Participants will maintain a diet log at home, interview with a registered dietician, complete a body composition analysis, and participate in fasting blood draw and medical screening.
Qualification Summary This study is for adults (18-65 years old) with complete motor loss (AIS A, B, C) in their spine (C4-L2 region) from an injury at least one year ago. (contact for more information)
Status Enrolling
Principal Investigator Dr. Gary Farkas
Contact Gary J. Farkas, Ph.D.
ALTERED BODY REPRESENTATION IN PEOPLE WITH SPINAL CORD INJURY AND ITS ASSOCIATION WITH PAIN SENSATION
Purpose To define changes in body ownership underlying compromised multisensory integration in spinal cord injury (SCI) individuals by using the rubber hand illusion procedure (RHI); ii) to determine the relation between compromised multisensory integration after SCI and its impact on pain.
Qualification Summary This study is recruiting three groups of adults (18-50 years old) for a pain research visit: people with incomplete spinal cord injury and chronic pain, people with incomplete spinal cord injury but no pain, and healthy volunteers with no history of injury. (contact for more information)
Status Enrolling
Principal Investigator Eva Widerstrom-Noga, Ph.D.
Contact Linda Robayo Riofrio, Ph.D.
PHYSIOLOGICAL AND BEHAVIORAL REGULATION OF FEEDING AFTER SPINAL CORD INJURY
Purpose The goal of this study is to determine the effects of spinal cord injury on appetite and gut metabolism following 2 meals in adults with and without SCI.
Qualification Summary Adult men and women with complete and incomplete C3-L3 chronic (at least 1-year post-injury) spinal cord injury (AIS A, B, and C). (contact for more information)
Status Concluding recruitment
Principal Investigator Gary J. Farkas, Ph.D.
Contact Gary J. Farkas, Ph.D.
COMPARING CLINICALLY VALIDATED UPPER-EXTREMITY ASSESSMENTS IN SCI
Purpose This study aims to compare four common assessments used to measure upper limb function in adults with chronic tetraplegia. Researchers will assess participants using the GRASSP, CUE-T, ARAT, and Wolf Motor tests and compare their effectiveness in evaluating hand and arm function.
Qualification Summary This study is for adults (over 18) with chronic spinal cord injury in the neck (C2-C7) for over a year, regardless of injury severity (ASIA A-D), but excludes people with severe upper arm spasticity, fractures/contractures, or who cannot consent. (contact for more information)
Status Enrolling
Principal Investigator David W. McMillan, Ph.D.
Contact Nilanjana Datta, M.D.
DEVELOPING A MULTI-CHANNEL QUANTATIVE AUTONOMIC DIAGNOSTIC TO ASSESS THE SYMPATHETIC LEVEL OF INJURY
Purpose The study seeks to adapt the sympathetic skin response (SSR) test to determine the sympathetic level of injury (SLOI) in individuals with and without spinal cord injury (SCI), aiming to understand the correlation between sympathetic and somatic levels of injury. This investigation addresses the need for a clinically useful method to quantify sympathetic LOI, potentially enhancing practitioners’ understanding of changes in involuntary bodily functions following SCI.
Qualification Summary Adults with and without spinal cord injury. (contact for more information)
Status Approved, not yet recruiting
Principal Investigator David W. McMillan, Ph.D.
Contact David W. McMillan, Ph.D.
URSOLIC ACID FOR MUSCLE STRENGTH AND GLYCEMIC CONTROL IN SCI
Purpose The purpose of this pilot study is to assess the potential of Ursolic Acid (UA) in mitigating muscle wasting and insulin resistance in individuals with chronic spinal cord injury (SCI). By investigating UA’s effects on muscle mass, strength, and metabolic parameters, the study aims to provide insights into potential therapeutic strategies for improving health outcomes in the SCI population.
Qualification Summary This study is for men and women aged 18-65 with chronic (over 1 year) spinal cord injury, either complete or incomplete (AIS A/B/C), in either the thoracic (T2-T8) or cervical (C4-C7) spine. It excludes pregnant or breastfeeding women. (contact for more information)
Status Concluding recruitment
Principal Investigator Mark S. Nash, Ph.D.
Contact Patricia Grahm
EXPLORING EFFECT OF MINDFULNESS ON QUALITY OF LIFE IN SCI
Purpose The purpose of the study is to explore the impact of a one-month mindfulness intervention on physiological stress markers and quality of life in individuals with spinal cord injury (SCI). By measuring changes in heart rate, blood pressure, metabolism, and quality of life scores before and after the intervention, the study aims to provide insights into the potential benefits of mindfulness practices for SCI patients.
Qualification Summary This study is for adults (18-70) with spinal cord injury (C5-T10, any severity), who are healthy and able to consent, but excludes pregnant women and those on certain medications. (contact for more information)
Status Approved, not yet recruiting
Principal Investigator Mark S. Nash, Ph.D.
Contact Patricia Grahm
BRAIN-CONTROLLED SPINAL SIMULATION THERAPY FOR RESTORATION OF WALKING AFTER INCOMPLETE SCI
Purpose The purpose of this pilot clinical trial is to investigate the therapeutic effects of non-invasive Brain-Computer Interface (BCI)-Transcutaneous Spinal Cord Stimulation (TSCS) therapy for improving neuromotor recovery in individuals with incomplete spinal cord injury (SCI). Through exploring effective therapy methods and optimizing brain decoding algorithms, the study aims to establish the feasibility and efficacy of long-term BCI-TSCS locomotor therapy, potentially offering a novel approach to enhance walking function in this population.
Qualification Summary This study is for adults (21-70 years old) with incomplete spinal cord injury (more than 6 months old) who have some leg movement and can commit to a 6-month training program. It excludes people with other neurological problems, severe spasticity, certain medical conditions, or metal implants. (contact for more information)
Status Enrolling
Principal Investigator Matija Milosevic, Ph.D.
Contact: Patricia Grahm
RELATION BETWEEN RESPIRATORY PERFORMANCE AND SEATED BALANCE IN SCI
Purpose This study aims to investigate the relationship between breathing and balance in individuals with chronic spinal cord injury (SCI), focusing on how these functions impact quality of life and daily activities. Despite the known connection between breathing and balance, this link is not well-understood, especially in chronic SCI patients.
Qualification summary Adults with spinal cord injury. (contact for more details)
Status Re-opening for enrollment
Principal Investigator Mark S. Nash, Ph.D.
Contact David W. McMillan, Ph.D.
SPINAL CORD NEUROMOULATOR BY SPINEX AND SCONE TO TREAT NEUROGENIC BLADDER
Purpose The purpose of the SCONE “CONTINENCE” CLINICAL STUDY is to evaluate the efficacy and safety of the SpineX Spinal Cord Neuromodulation (SCONE) Device in treating Neurogenic Lower Urinary Tract Dysfunction (NLUTD) resulting from spinal cord injury, multiple sclerosis, or stroke. This prospective, multicenter, single-blind, randomized sham-controlled study aims to assess the comparative effectiveness of SCONE neuromodulation therapy versus inactive sham control in improving symptoms of NLUTD over a 12-week period.
Qualification Summary This study is for men and women aged 18-75 with lower urinary tract dysfunction due to spinal cord injury, stroke, or multiple sclerosis. They must be able to self-catheterize or have urgency/frequency urination. It excludes people with certain medical conditions, catheters, or implants, and those who are pregnant, breastfeeding, or have significant social/psychological problems. (contact for more information)
Status Recruitment concluding
Principal Investigator Raveen Syan, M.D.
Contact: Zoe Szczotka
THE MICROBIOME AFTER SCI: GASTROINTENSTINAL DYSFUNCTION MECHANSISMS AND MARKERS OF GI STATUS
Purpose The purpose of this study is to investigate the impact of spinal cord injury on the intestinal microbiome and epithelium, aiming to uncover mechanisms underlying gastrointestinal dysfunction and identify potential biomarkers. By examining alterations in gut microbiome composition and intestinal tissue function, the study seeks to inform the development of personalized therapeutic interventions for individuals with spinal cord injury.
Qualification Summary This study is for people aged 18-65 with spinal cord injury (tetraplegia or paraplegia) and constipation or bowel problems, or for healthy people of the same age range. It excludes people with certain medical conditions, implants, or recent surgery, and those who are pregnant or breastfeeding. (contact for more information)
Status Enrolling
Principal Investigator Sylvia Daunert, Phar.M.D., Ph.D.
Contact Gregory O’Connor, Ph.D.
NUTRITION EDUCATION PROGRAM IN SCI (NEURO-NUTRITION CLINIC)
Purpose This study aims to assess whether a year-long nutrition education program improves dietary knowledge and related health markers in individuals with spinal cord injury. Researchers will compare bloodwork, body measurements, and nutrition knowledge tests before and after the program.
Qualification Summary This study is for consenting adults (18+) with spinal cord injury (paraplegia or tetraplegia), but excludes pregnant women, children, and prisoners. (contact for more information)
Status Enrolling
Principal Investigator Elizabeth Felix, Ph.D.
Contact Alicia Sneij, Ph.D., R.D | phone: +1-305-978-4079 | email: a.sneij@umiami.edu
If you would like to be considered for these or future Miami Project trials or studies, please see our Register for a Research Program section, send us a message, or call The Miami Project Education Office at 305-243-7108.