Enhancing Recovery in Non-Traumatic Spinal Cord Injury: Implementation of an Integrated Program for the Assessment of Rehabilitation Therapies
The investigators have spent the last decade uncovering unique metabolic and functional abnormalities in the brains of patients with spinal cord compression. Degenerative spinal cord compression represents a unique model of reversible spinal cord injury. In the investigator's previous work, they have demonstrated that cortical reorganization and recruitment is associated with metabolic changes in the brains of patients recovering from spinal cord compression and is correlated with recovery and improved neurological scores. The goal of this study is to combine a rigorous platform of clinical care that includes preoperative evaluation, surgery, and rehabilitation, with state of the art imaging techniques to demonstrate how rehabilitative therapy can increase brain plasticity and recovery of neurological function in patients with spinal cord injury. Neurological function will be carefully evaluated in two groups of patients, those receiving rehabilitation and those not receiving rehabilitation after spine surgery, and will be correlated with the results of advanced imaging.
NCT03320759 — Spinal Cord Injuries
Status: Recruiting
http://inclinicaltrials.com/spinal-cord-injuries/NCT03320759/
Phase I Clinical Trial of Autologous Adipose Derived Mesenchymal Stem Cells in the Treatment of Paralysis Due to Traumatic Spinal Cord Injury
The purpose of this study is to determine if mesenchymal stem cells (MSC) derived from the fat tissue can be safely administered into the cerebrospinal fluid (CSF) of patients with spinal cord injury. Adipose-derived mesenchymal stem cells (AD-MSCs) have been used in previous research studies at the Mayo Clinic. All subjects enrolled in this study will receive AD-MSC treatment, which is still experimental and is not approved by the U.S. Food and Drug Administration (FDA) for large scale use. However, the FDA has allowed the use of this agent in this research study.
NCT03308565 — Spinal Cord Injuries
Status: Completed
http://inclinicaltrials.com/spinal-cord-injuries/NCT03308565/
The Effectiveness of Early Sacral Nerve Stimulation in Improving Bladder- Related Complications and Quality of Life After Acute Traumatic Spinal Cord Injury
The purpose of this study is to see what effects sacral neuromodulation has on bladder function and quality of life in patients with acute spinal cord injury. Within 12-weeks of injury, participants will either receive an implanted nerve stimulator (like a pace-maker for the bladder) or standard care for neurogenic bladder. Patients will be assigned to one of these groups at random and followed for one year. The hypothesis is that early stimulation of the nerves will help prevent the development of neurogenic bladder.
NCT03083366 — Urinary Tract Infections
Status: Terminated
http://inclinicaltrials.com/urinary-tract-infections/NCT03083366/
Treating Cognitive Deficits in Traumatic Spinal Cord Injury: A Randomized Clinical Trial
Multiple studies in the spinal cord injury (SCI) population have documented deficits in learning and memory (LM) and processing speed (PS) that adversely impact daily life and the ability to benefit from rehabilitation. The investigators have previously attributed the cognitive deficits demonstrated in the SCI population to low blood pressure (BP) and cerebral blood flow (CBF) and are currently conducting a study to determine the effect of a 30-day elevation in BP (using midodrine hydrochloride - an alpha agonist) on CBF and cognitive performance compared to placebo in hypotensive individuals with SCI. In addition, the investigators believe that cognitive behavior therapy (CBT) may improve cognition independent of changes in BP and CBF in individuals with SCI. The current randomized clinical trial (RCT) will examine the efficacy of 2 treatment protocols shown to be effective in improving cognitive performance in other neurologically impaired populations for use in persons with SCI demonstrating (1) LM impairment and/or (2) PS impairment on objective measures of cognitive functioning during a complete Neuropsychological assessment. Two methods of outcome assessment will be used to examine treatment impact: (1) a traditional Neuropsychological assessment (NP) and (2) an assessment of global functioning (AGF) composed of broader outcome measures that examine the impact of the treatment on everyday life activities. In this way, the investigators will be able to objectively evaluate the presence or absence of changes in memory performance through a NP assessment, while also evaluating the impact of this treatment protocol on everyday life through the AGF. While most studies evaluating the efficacy of cognitive retraining usually employ a pre- and post-training evaluation, such evaluations have been criticized for their lack of ecological validity (i.e., real world generalizability). The present design allows the assessment of the efficacy of these treatment techniques within an SCI population using traditional measures, as well as the assessment of the impact that treatment has on everyday life. The investigators will additionally evaluate the long-term efficacy by including a 6-month post-treatment follow-up. Few studies examine long-term effects, but given the time, labor and expense involved, it is critical to demonstrate long-term efficacy.
NCT03037879 — Blood Pressure
Status: Completed
http://inclinicaltrials.com/blood-pressure/NCT03037879/
A Phase I/IIa, Randomized, Double-blind, Single-dose, Placebo Controlled, Two-way Crossover Clinical Trial to Assess the Safety and to Obtain Efficacy Data in Intrathecal Administration of Expanded Wharton's Jelly Mesenchymal Stem Cells in Chronic Traumatic Spinal Cord Injury
This is a phase I/IIa, randomized, double-blind, two-arms, two-dose administration, placebo controlled, two-way crossover clinical trial in which 10 patients from 18 to 65 years of age affected with chronic traumatic spinal cord will enter the study with the objective to assess the safety and to obtain efficacy data in intrathecal administration of expanded Wharton's jelly mesenchymal stem cells.
NCT03003364 — Spinal Cord Injury, Chronic
Status: Completed
http://inclinicaltrials.com/spinal-cord-injury-chronic/NCT03003364/
Association Between Depressive Symptoms and Sexual Dysfunction in Men With Traumatic Spinal Cord Injury
Aims: assess the relationship between sexual function and depressive symptoms in individuals with spinal cord injury.
NCT02958904 — Spinal Cord Injuries
Status: Completed
http://inclinicaltrials.com/spinal-cord-injuries/NCT02958904/
Clinical Trial of Phase 1/2 to Evaluate the Feasibility, Safety, Tolerability and Preliminary Efficacy of the Administration of FAB117-HC, a Drug Whose Active Ingredient is HC016, Allogeneic Adipose Derived Adult Mesenchymal Stem Cells Expanded and Pulsed With H2O2, in Acute Traumatic SCI Patients.
The main objective of the study is the evaluation of the safety and tolerability of FAB117-HC (a medicinal product containing human allogeneic adipose derived adult mesenchymal stem cells expanded and pulsed with H2O2, HC016 cells) administered at a single-time point to patients with acute thoracic traumatic spinal cord injury (SCI). The study will also include initial exploration of potential clinical efficacy. Dose levels of 20 million and 40 million cells will be administered.
NCT02917291 — Acute Traumatic Spinal Cord Injury
Status: Recruiting
http://inclinicaltrials.com/acute-traumatic-spinal-cord-injury/NCT02917291/
Predictive Factors for Male Sexual Dysfunction After Traumatic Spinal Cord Injury
Objective: To analyze the association between sexual function of men with spinal cord injury with possible predictive factors for dysfunction.
NCT02860689 — Spinal Cord Injury
Status: Completed
http://inclinicaltrials.com/spinal-cord-injury/NCT02860689/
Biomarkers of Spontaneous Recovery From Traumatic Spinal Cord Injury
The purpose of the study is to profile biochemical responses and measure functional recovery in parallel, throughout the 1st year after spinal cord injury (SCI), within the same participants. These responses and recovery will be evaluated in samples from people who have had a spinal cord injury due to trauma (e.g. car accident or a fall) within the first year after SCI. Specifically, the investigators will test the hypothesis that a subset of inflammatory biomarkers correlate inversely with functional recovery. The investigators will use these data to build a predictive model of functional recovery after SCI that incorporates biomarkers that can be easily quantified in the clinic. Total anticipated enrollment will be 100 participants with SCI across three different sites (Northwell Health System (NY), The Kessler Institute for Rehabilitation (NJ), University of Louisville (KY) and may enroll up to 30 participants without SCI.
NCT02731027 — Spinal Cord Injury
Status: Completed
http://inclinicaltrials.com/spinal-cord-injury/NCT02731027/
The Effects Upon the Bladder of Transcutaneous Tibial Nerve Stimulation in Acute Traumatic Spinal Cord Injury
The purpose of this research study is to evaluate the effects upon the bladder of electric stimulation of the leg's tibial nerve in people with acute spinal cord injury with an intervention called transcutaneous tibial nerve stimulation (TTNS).
NCT02573402 — Spinal Cord Injury
Status: Completed
http://inclinicaltrials.com/spinal-cord-injury/NCT02573402/