The Mount Sinai Spinal Cord Injury Model System of the Department of Rehabilitation Medicine provides a regional multidisciplinary system of care that includes a number of innovative clinical programs for people with spinal cord injury (SCI) in the New York City metropolitan area. The system contributes longitudinal data about persons with SCI to the SCI National Database. The National Database includes more than 30,000 individuals. Persons with acute injury who are enrolled in a Model System can remain in the database and contribute to our knowledge of SCI throughout their lifetime. Investigators perform approximately 300 follow-up interviews per year at Mount Sinai.

The objectives of the Mount Sinai Spinal Cord Injury Model System focus on improving the quality of life of persons with SCI through:

• State-of-the-science clinical care
• Innovative research
• Multi-platform extensive dissemination of research results and other information on SCI to consumers and professionals

The comprehensive clinical program consists of

• NYC Emergency Medical Services, ensuring the early and safe extrication of individuals with SCI from the injury site, pre-hospital care, and rapid transport to a trauma center
• Emergency department and acute medical/surgical care units within the Mount Sinai Health System, including the Mount Sinai Morningside Trauma Center
• Comprehensive CARF-accredited SCI acute inpatient and outpatient rehabilitation services taking place within a 25-bed SCI inpatient rehabilitation unit (serving 60 patients with traumatic SCI each year) and a large outpatient area. Core rehabilitation services include physical therapy, occupational therapy, speech-language pathology, social work, peer mentoring, outreach coordination, rehabilitation psychology, therapeutic recreation, and vocational rehabilitation.

The research program of the Mount Sinai Spinal Cord Injury Model System aims to improve the quality of life for SCI survivors by developing effective treatments of post-SCI secondary conditions.

Current projects include:

• A local randomized clinical trial that will evaluate the Safety, feasibility, and efficacy of transcutaneous spinal cord stimulation on stabilizing blood pressure for acute inpatients with spinal cord injury
•  
• Participation in three collaborative module research projects with other model systems. Currently, these include:
  • Feasibility, Reliability, and Long-term Prognostic Capability of the International Standards to Document Autonomic Function after Spinal Cord Injury (ISAFSCI) during acute inpatient rehabilitation – Mount Sinai Lead Module 
    •  
    • Accelerating Racial and Ethnic Equity in SCI Rehabilitation Outcomes Module
    • The Status of Oral Health in People with Spinal Cord Injury in the United States Module

Dissemination activities include a monthly e-newsletter, The Spinal Connection; accessible web-based information; journal publications; presentations at international, national, regional, and local meetings; and involvement of consumers through a Community Advisory Committee.

Thomas Bryce, MD is the principal investigator of this project.

People with spinal cord injury (SCI) can have an abrupt loss of upright mobility, function and physical activity. Inflammation and pain are reported to be increased, with negative impacts on quality of life. Powered exoskeletons are a technology that offer standing and walking for eligible persons with SCI and have been used in the chronic SCI population with positive benefits in mobility, function, body composition, and quality of life (QOL). Despite the potential for exoskeletal-assisted walking (EAW) to promote functional recovery and mitigate secondary medical complications, few reports exist on the use of exoskeletons in acute inpatient rehabilitation (AIR).

The goal of this study is to test the effects of early EAW training (incorporated into regular AIR) on accelerating functional recovery and reducing pain and inflammation. A total of 30 people with non-progressive SCI (≥18 years; <6 months after SCI), who are clinically eligible for gait training during AIR, will be randomly assigned into one of two groups. The intervention group will receive gait training with an Ekso^TM powered exoskeleton, incorporated into usual 3-hour AIR (AIR with EAW group, 20 participants).

The control group will have usual 3-hour AIR, but without using an exoskeleton (AIR only group, 10 participants). Motor function, functional activities, pain and inflammation will be assessed after enrollment in the study and before discharge from AIR. The impact of successful completion of this study would increase knowledge of the effects of using EAW during acute/subacute AIR.

The expected outcome of this study is that EAW during AIR may have the potential on accelerating functional recovery and mitigating some of the secondary consequences of paralysis from SCI during the early phases of recovery and rehabilitation.

Dr. Ann M. Spungen is the principal investigator of this project.

The purpose of this research study is to test the safety of a new investigational noninvasive spinal cord stimulation device called ExaStim and to see if it will help improve movement and sensation in the upper body, arms, and hands of individuals with spinal cord injury.

If you choose to participate, you will be asked to:

• Attend all scheduled visits (a total of 28 visits, lasting approximately 13 weeks), including a screening visit to ensure you meet all of the criteria for the study, 24 visits where you will receive the study treatment or a sham treatment, 2 visits to check on your hand functions in the middle and end of the treatment, and a follow-up visit 4 weeks after the last treatment visit to check on your well-being
• Answer any questions truthfully, including questions about your medications and medical history
• Be willing and able to follow the study directions and procedures
• Tell the study staff about any problems or side effects
• Ask questions as you think of them
• Tell the investigator or study staff if you change your mind about staying in the study
• Receive study compensation

The ASPIRE study is currently enrolling participants who are at least 22 years of age and have a traumatic, chronic spinal cord injury between C2 and T2, but who maintain limited function of the upper extremities. Participants must be willing to cooperate with the study requirements, including compliance with the treatment plan and completion of all office visits at Mount Sinai. Interested?
Visit the ASPIRE Study website and click “See if You May Qualify” or contact Arianny Ramirez for more information.

Chung-Ying Tsai, PhD is the principal investigator of this project.

The Safety, feasibility, and efficacy of transcutaneous spinal cord stimulation on stabilizing blood pressure for acute inpatients with spinal cord injury is part of the Mount Sinai Spinal Cord Injury Model System. Participants in this research study can participate in this specific study if they qualify for the MAIN STUDY.

Following SCI, patients often lose their ability to regulate their blood pressure. Many patients experience dizziness, nausea and may pass-out during therapy because of hypotension (low resting blood pressure) and orthostatic hypotension (falls in blood pressure when sitting-up or standing).  This experience can prevent these individuals from adhering to therapy which can in turn limit long-term outcomes. Ensuring that newly injured patients with SCI can follow through on their prescribed therapy program is therefore essential. Spinal cord stimulation (SCS) is a form of therapy that may improve blood pressure in patients with SCI, thus allowing for better participation in prescribed therapy. The goal of this study is to determine the safety and feasibility of using transcutaneous spinal cord stimulation (TSCS), a non-invasive form of SCS, that is applied to the skin over the spine, to stabilize blood pressure within a target range during acute inpatient rehabilitation in newly injured patients with traumatic SCI. We define the target range as a systolic blood pressure between 110-130 mmHg in males and 100-130 mmHg in females. Participants will receive stimulation in conjunction with their daily therapy sessions. To assess safety, we will document levels of blood pressure, pain, discomfort, and skin integrity after application of TSCS. To evaluate the feasibility, we will develop a standard mapping algorithm designed to be easily followed by clinical therapists. We will determine the immediate effect of TSCS to increase blood pressure, improve brain blood flow and reduce symptoms of orthostatic intolerance after a bedside sit-up test. We will also look at the effect of TSCS on cumulative blood pressure stability, muscle strength, and adherence to prescribed therapy program during acute inpatient rehabilitation.

Dr. Thomas Bryce is the principal investigator of this project.

For more information please contact:  Jorge Chavez at Jorge.Chavez2@mountsinai.org.

The purpose of this research study is to investigate and better understand neuropathic pain following a spinal cord injury (SCI), during acute inpatient rehabilitation. Neuropathic pain is a complex and often severe form of pain experienced by individuals with SCI. For this reason, it is important to understand how often neuropathic pain occurs in people with recent SCI.  It is also important to know how commonly used treatments, including medications and non-drug therapies, affect the way neuropathic pain is felt and how neuropathic pain changes over time and to understand how neuropathic pain may interfere with life activities. It is also important to be able to identify biological substances that can be tested for in the blood that may be related to the development of the pain. Substances which hold promise include proteins found within cells that are released after SCI, one of which is HMGB1, that have been linked to the development of neuropathic pain.

Understanding neuropathic pain after SCI may provide clinicians with better tools to diagnose and treat pain. Having a better understanding of neuropathic pain could help guide clinical decisions and inform newly injured people on what to expect in the long-term with regard to their pain. The findings from this study (i.e. study results) could provide clinicians with potential new approaches to treatment and ultimately the ability to improve the quality of life of those with spinal cord injury. 

Thomas Bryce, MD is the principal investigator of this project.

The purpose of this research study is to develop a valid and reliable interview and online self-report versions of the Motor and Sensory Components of the Neurological Exam for Classifying Spinal Cord Injury.

The study has two parts: [1] fine tuning the questions and other materials to be used in the interview and the online version of the motor and sensory components, and [2] comparing the results of either one with those of a second administration, and with those of the in-person administration. You can take part in Part 1 only, part 2 only, or in both. We will finish the Part 1 of the study first and then conduct the Part 2 of the study:

1. If you participate in Part 1, you will be asked to complete either the interview or the online version of a questionnaire. Both have visual aids, and clinicians or researchers will administer the questions to or with you during a virtual contact (phone or video or online conference) or in-person interview. You will also be asked to answer questions related to your understanding of the questions in the interview or online version, and the reasons you selected certain answers. The whole process may take up to 2 hours.
2. If you participate in Part 2, you will complete either the interview version or the online version twice, and then make a clinic visit at the Mount Sinai Hospital or Kessler Institute for Rehabilitation (study sites) to receive an in person examination. Either Part 1 or Part 2 of the study takes you about 2 hours in total to complete. Your participation in the study (or decision not to become a participant) will not affect the care you will receive from Mount Sinai.

If you agree to take part in Part 1 of this research study, we will pay you $200 via check or money order for your time and effort at the end of your participation in the study. If you agree to take part in Part 2 of this research study, we will pay you $250 via check or money order for your time and effort at the end of your participation in the study.

The American Spinal Injury Association neither endorses nor is affiliated with the study or the creation of any of the content used in the study.

This study is currently closed for enrollment.

Thomas Bryce, MD is the principal investigator of this project.