Spinal Cord Injury Studies

Nerve Transfers to Improve Upper Extremity Function and Quality of Life in Tetraplegic Patients 

            Sponsor: Department of Defense

  • A prospective multi-institutional clinical trial enrolling 70 subjects with cervical ASIA  (American Spinal Injury Association) A or B spinal cord injury (SCI) and hand function impairment.
  • The rationale for this research is establishing  data for treating SCI patients with nerve transfers. It will provide guidance for  clinical management and will prove useful in generating treatment algorithms incorporating nerve and tendon transfer strategies. We also expect these findings will serve as a useful tool in counseling families and in patient selection for surgery.
  • Subjects will undergo a nerve transfer in the arm taking a donor nerve from above the neurologic injury and transfer it to a nerve below the injury. Patients will undergo hand/arm therapy and will be followed for 4 years post-surgery.

ClinicalTrials.gov – NCT04023591

Intake Questionnaire

 

A Study to Investigate the Safety, Tolerability, Pharmacokinetics of Single Ascending Dose of MT-3921 in Subjects with Acute Spinal Cord Injury

            Sponsor: Mitsubishi Tanabe Pharma Development America, Inc.

  • Multi-center, Phase 2a clinical trial
  • The purpose of this research is to assess the safety and efficacy of the study drug, MT-3921, an anti-body to Repulsive Guidance Molecule Type a (RGMa).
  • The study drug will be administered as an intravenous (IV) infusion within 48 hours of injury. Subjects will receive study drug or a placebo.  The drug or placebo will be administered 6 more times throughout the study – at 15 days, 30, 60, 90, 120 and 150 days post-injury. Bloodwork will be collected.  Neuro exams and questionnaires will be collected throughout the study.  Participants will be followed for 9 months after injury.

Study to Assess the Efficacy and Safety of MT-3921 in Subjects With Acute Traumatic Cervical Spinal Cord Injury – Full Text View – ClinicalTrials.gov

A Randomized, Double-Blinded, Placebo-Controlled Proof of Concept Study to Assess the Safety and Efficacy of Elezanumab in Acute Traumatic Cervical Spinal Cord Injury

            Sponsor: AbbVie

  • Multi-center, randomized, double-blinded, placebo controlled clinical trial
  • The purpose of this research study is to determine if the study drug, elezanumab, is safe and improves function in patients with an acute traumatic cervical spinal cord injury.
  • Participants will be randomly assigned to  either the study drug or the placebo. Blood will be collected pre-and post-operatively at several time points.  Study drug will be administered by an IV infusion at 13 different time points throughout the study.  Neuro exams and questionnaires will be collected.  Participants will be followed for approximately 18 months.

Clinical.Trials.gov – NCT 04295538

Discovery of Biomarker Signatures Prognostic for Neuropathic Pain After Acute Spinal Cord Injury

       Sponsor: National Institute for Health

  • Multi-Center, non-blinded, two-arm design comparing participants with an acute spinal cord injury to age/sex-matched healthy control subjects.
  • The objective of this research study is to develop a biomarker signature that will help predict SCI-induced neuropathic pain. The ultimate goal is to identify new non-addictive treatments for its prevention.
  • SCI participants will undergo the standard of care treatment for their injury. Blood will be collected at several time points.  Neuro exams, sensory exams and  questionnaires will be collected postoperatively.  Participants will be followed for 6 months.  Control subjects will come in for a blood draw one time.

ClinicalTrials.gov – NCT00913471

Lumbar Spine (lower back)

Enhanced Recovery after Surgery (ERAS) and Awake Spine Surgeries

  • A prospective- observational study enrolling subjects scheduled for a MIS TLIF.
  • The study follows MIS TLIF patients that are part of the Enhanced Recovery After Surgery Hospital Program (ERAS). The hospital program is also referred to as the Rapid Recovery or Rapid Response program.The goal is to decrease the amount of time patients stay in the hospital. Patients may undergo their surgery with the use of the drug Exparel (an FDA approved anesthesia drug that is being used for the intended purpose. Pacira Sciences, Inc. is providing a limited number of samples.
  • The goal is to decrease the amount of time patients stay in the hospital. Patients may undergo their surgery with the use of the drug Exparel (an FDA approved anesthesia drug that is being used for the intended purpose. Pacira Sciences, Inc. is providing a limited number of samples. 

        *** Exparel may also be used as standard of care. This is not a drug study. The study is just following the hospital program.

      • A substudy of this program tracks patients that undergo awake spinal surgery. Currently we are not doing any Awake TLIF surgeries.
      • The purpose of this research is to compare the outcomes and costs of patients in the ERAS programs to a retrospective cohort that previously underwent minimally invasive spine surgery.
      • Patients will undergo the standard of care treatment for their spinal condition. Questionnaires along with opioid usage will be will be collected. Patients will be followed for two years post-surgery.

      Using Ecological Momentary Assessments Develop Individualized Profiles of Lumbar Fusion Patients

      Abbreviated Title: EMA Study

      Study Status: Currently recruiting study patients

      • Prospective-Observational study
      • The purpose of the study is to use mobile health technology –smart phones and Fitbits to capture a more accurate picture of how spine disease affects patient’s daily life. The goal is to examine whether the use of mobile technology will allow us to better guide patients in the future on what to expect from their treatment and recovery.

      Peripheral Nerves

      Identification and Validation of Non-invasive Mechanomyography as a Valuable Predictor of Clinical Course and Long-term Prognosis for Cubital Tunnel Syndrome and Peroneal Nerve Decompression Patients

                Sponsor: DePuy

      • Non-blinded two-arm design consisting of symptomatic patients with Cubital Tunnel Syndrome (CuTS) or Compressive Peroneal Nerve Neuropathy (CPNN).
      • The purpose of this study is to establish and validate non-invasive MMG biomarkers that may help to predict how well patients will do following surgical decompression in mild and moderate CuTS and CPNN.
      • Both arms will undergo standard of care testing and treatment. During surgery, the surgeon will perform a mechanomyography (MMG) immediately pre-decompression and immediately post-decompression of the nerve.  This is done by placing the sensor and probe on the nerve that will be decompressed.  Patients will be followed for 6 months.