Spinal Cord Injuries Clinical Trials

Spinal cord injury (SCI) is associated with severe neuropathic pain that is often refractory to pharmacological intervention. Preliminary data suggest brivaracetam is a mechanism-based pharmacological intervention for neuropathic pain in SCI. Based on this and other reports in the literature, SCI-related neuropathic pain is hypothesized to occur largely because of upregulation of synaptic vesicle protein 2A (SV2A) within the substantia gelatinosa of the injured spinal cord. Furthermore, compared to placebo, brivaracetam treatment is hypothesized to reduce severe below-level SCI neuropathic pain and increases parietal operculum (partsOP1/OP4) connectivity strength measured by resting-state functional Magnetic Resonance Imaging (rsfMRI). Circulating miRNA-485 levels may be associated with change in pain intensity due to brivaracetam treatment. The study aims to determine the efficacy of brivaracetam treatment for SCI-related neuropathic pain. Read Less

The purpose of this study is to develop a health promotion group intervention to meet the unique health promotion needs of people aging with SCI, to test the efficacy of the adapted intervention program, Living Longer and Stronger with SCI, in a randomized controlled trial and to assess the mechanisms through which the intervention may enhance physical, psychological, and social health. Read Less

The purpose of this study is to examine the relationship between common clinical assessments and measurements of the function of brain-spinal cord-muscle connections, and to examine the effects of training a brain-spinal cord-muscle response in individuals with incomplete spinal cord injury. A transcranial magnetic stimulator (TMS) is used for examining brain-to-muscle pathways. This stimulator produces a magnetic field for a very short period of time and indirectly stimulates brain cells with little or no discomfort. The target muscle is the wrist extensor (extensor carpi radialis) muscle that bends the wrist back. It is hypothesized that training the wrist extensor muscle response to transcranial magnetic stimulation will increase the strength of the brain-to-muscle pathway, which will improve the ability to move the arm. It is hoped that the results of this training study will help in developing therapy strategies for individuals, promoting better understanding of clinical assessments, and understanding treatments that aim to improve function recovery in people with spinal cord injury (SCI). This study requires 30 visits, and each visit will last approximately 1.5 hours. Read Less

The purpose of this study is to develop and test the hardware and software components of the MyHand-SCI device to assist with hand function for individuals with C6-C7 spinal cord injury. Read Less

Locomotor training is often used with the aim to improve corticospinal function and walking ability in individuals with Spinal Cord Injury. Excitingly, the benefits of locomotor training may be augmented by noninvasive electrical stimulation of the spinal cord and enhance motor recovery at SCI. This study will compare the effects of priming locomotor training with high-frequency noninvasive thoracolumbar spinal stimulation. In people with motor-incomplete SCI, a series of clinical and electrical tests of brain and spinal cord function will be performed before and after 40 sessions of locomotor training where spinal stimulation is delivered immediately before either lying down or during standing. Read Less

The goal of this clinical trial is to investigate the effects of transcutaneous spinal cord stimulation (TSCS) combined with exoskeleton training, as compared to exoskeleton training alone to improve motor function in individuals with incomplete spinal cord injury who are 12 months or less post-injury. Participants will be randomly assigned to a treatment group (exoskeleton training with TSCS, or exoskeleton training without TSCS). Participants in both groups will undergo a baseline evaluation, then take part in 24, 1-hour training sessions at Craig Hospital. After the 24 sessions have concluded, participants will undergo a post-treatment evaluation as well as a follow-up evaluation four weeks after training is completed. Researchers will compare the two groups by evaluating the following areas: walking ability and speed lower extremity strength, activation, and spasticity trunk control bowel and bladder function Read Less

Aim 1: Determine the safety and feasibility of administration of TSCS to children in a clinical setting. Participants will be randomly assigned to experimental (TSCS) or control (sham stimulation) groups. Both groups will receive eight-weeks of individualized gait training. We will measure adverse events, including pain and skin irritation, to determine safety as the primary outcome. Hypothesis 1: Administration of TSCS to children in a clinical setting will be safe based on similar safety outcomes as sham TSCS. Hypothesis 2: TSCS is feasible based on compliance to session interventions and long-term adherence to the protocol. Additionally, we will collect data on effort during sessions of both participant and therapist. We anticipate that the participants will report less effort in the experimental condition, as compared to the control and therapists will report equal effort across conditions. Aim 2: Determine the neurophysiologic impact of TSCS within a single session. We hypothesize that participants will demonstrate increased volitional muscle activity and strength with TSCS as compared to sham stimulation. This will be assessed by surface EMG and hand-held dynamometry of the dominant-side quadriceps muscle during maximum volitional contraction (MVC), across multiple time points. Changes in EMG activity will indicate change in central excitability in response to stimulation. Aim 3: Exploratory measurement of TSCS and gait training on walking function. We hypothesize that concurrent TSCS and gait training will augment walking function in children with iSCI, as compared to gait training with sham stimulation. In addition to outcomes defined above, participants will be assessed with clinically relevant outcome measures, to include the Timed Up and Go, 10-Meter Walk Test, Walking Index for Spinal Cord Injury II, and 6-Minute Walk Test. Data collected as part of this aim will elucidate trends in responder qualities and timeline of changes to inform future studies. Read Less

This is a double-blind, 12-month pilot study to evaluate of the safety, feasibility, and preliminary efficacy of dorsal myelotomy and expansive duraplasty performed either without or with autologous nerve graft implantation after acute traumatic spinal cord injury. Ten participants will be allocated to receive either DMED (n=5) or DMED + ANGI (n=5) based on a block design. Participants and assessors will be blinded to group allocation. Excess sural nerve samples will be collected for banking/analysis (may include proteomic, culturing, genomic, cellular analysis). Read Less

The goal of this research is to increase physical activity among individuals with a spinal cord injury (SCI) through a customized, interactive smartphone-based health app and e-coaching using three phases: (1) leading focus groups of potential app users and clinicians to gain information regarding health apps preferences for optimal consumer use, (2) conducting a usability study of the customized app to determine the quality and implement further changes for optimization, and (3) conducting a sequential multiple assignment randomized trial (SMART) to determine the most effective adaptive intervention to improve exercise adherence. A SMART trial will be used to determine when and how to adapt dosage, timing, and delivery to increase adherence and address low-response behaviors. In Stage-I, the investigators will compare outcomes among participants using a generic, non-interactive exercise app (Group 1) to a customized, interactive app that can gain information through frequent Ecological Momentary Assessments (EMA) that will be used to modify each participant's exercise programs (Group 2). After 12 weeks, participants who are not meeting the exercise guidelines at least 50% of the time will also be asked to participate in motivational interviewing-based e-coaching either two or four times per month in addition to their originally assigned intervention (Stage-II). By completing these three phases, this project addresses deficiencies in exercise levels and compliance by implementing an individualized exercise prescription, an adaptive intervention for low responders, a way to address barriers to exercise, and a free smartphone app for broad implementation. Read Less

This is a single-cohort early feasibility trial to determine whether an investigational device called the Bidirectional Neural Bypass System can lead to the restoration of movement and sensation in the hand and wrist of up to three individuals with tetraplegia. Read Less

The proposed project seeks to maximize the functional recovery achieved during the rehabilitation of the paretic upper limbs in individuals with SCI. The investigation will work towards optimizing the use of transcranial direct current stimulation (tDCS), an adjunct known to improve the effectiveness of rehabilitation. In particular, the relationship between the specificity of current delivery and functional benefit will be explored, and findings may lead to a framework that can be translated to the clinic setting. Read Less

The investigators are conducting a research study to try to improve rehabilitation interventions for individuals with spinal cord injury (SCI). In this study, the aim is to determine if temporarily numbing non-paralyzed arm muscles with an over-the-counter numbing cream while exercising paralyzed muscles, can improve the strength, function, and sensation of paralyzed muscles after a spinal cord injury. Read Less