Clinical Research Directory

Nerve Transfer Surgery to Restore Upper-limb Function After Cervical Spinal Cord Injury

The goal of this prospective, open-label cohort study is to assess functional outcomes in individuals with cervical spinal cord injury who have undergone nerve transfer surgery to restore upper limb function. The main questions it aims to answer are: * Does nerve transfer improve hand function in individuals with cervical spinal cord injury? * What factors are associated with functional improvement following nerve transfer? Researchers will compare functional outcomes at 24 months post-surgery to 1) baseline outcomes and 2) individuals with cervical spinal cord injury who did not undergo nerve transfer. Participants who have received nerve transfer surgery as part of their regular medical care will complete functional hand tests, electrodiagnostic assessments, and questionnaires on independence and mood every 3 months for 24 months after surgery.

The Impact of Community-based Wellness Programs on The Triple Aim

People with disabilities experience a staggering incidence of secondary conditions that can result in death or negatively impact their health, participation in the community, and quality of life. Many of these chronic secondary conditions are preventable. The Institute for Healthcare Improvement has advocated for optimizing care through programs that simultaneously improve health and the patient experience of care, while reducing cost, called the "Triple Aim." Studies have shown that the Triple Aim can be achieved through programs that facilitate community integration; however the U.S. healthcare system lacks a paradigm of care for individuals with disabilities that promotes community integration. In order to identify potential models of healthcare delivery for individuals with disabilities that are effective in achieving the Triple Aim, we will conduct a rigorous research project to evaluate the impact of two different models of care on the Triple Aim: 1) a community-based care management program delivered by a non-profit organization through waiver funds, and 2) the Program for All-inclusive Care for the Elderly (PACE) applied to younger individuals with disabilities between ages 55-64.

Paired Stimulation Plasticity for Motor Recovery in Humans With and Without Spinal Cord Injury

This study will investigate how aging and spinal cord injury (SCI) affect the transmission and plasticity of the corticospinal and reticulospinal tracts, which are important pathways for motor control. The study includes two experiments. Experiment 1 will assess corticospinal and reticulospinal tract transmission to lower-limb muscles in older adults with and without SCI. Experiment 2 will examine how aging and spinal cord injury affect the body's ability to strengthen nerve pathways involved in movement. The investigators will compare two pathways that help control leg movement, the corticospinal and reticulospinal pathways, to determine whether aging affects these pathways differently and whether spinal cord injury has a greater effect on the corticospinal pathway.

Co-contraction and Corticoreticular Excitability in Spinal Cord Injury

This study is to elucidate whether hyperexcitability of the cortico-reticulospinal tract leads to abnormal co-contraction and spasticity of elbow flexors in persons with cervical cervical spinal cord injury. By measuring the supplementary motor area (SMA) regulation of the StartReact response, it is possible to quantify whether the cortico-reticular pathway is excessively active or weakened in these persons. Participants will 1. Be assessed for upper limb function 2. Receive motor evoked potential of tested biceps muscle 3. Receive a standard StartReact paradigm to measure the reticulospinal excitability. 4. Received a conditioning-test paradigm to assess corticoreticular excitability. 5. Conduct a sustained isometric elbow extension task

SERENITY Study of Chronic Pain Interference in Adults

SERENITY is a remote observational study designed to characterize inter-individual differences in chronic pain among adults with chronic low back pain and adults with spinal cord injury-related neuropathic pain. Participants will complete baseline assessments and intensive longitudinal data collection using ecological momentary assessment surveys, brief cognitive tests, and passive Fitbit data collection. Ecological momentary assessment surveys will be completed 4 times per day for at least 3 weeks and will assess pain interference, pain intensity, stress, affect, sleep, body and mind awareness, agency, medication use, manual therapy frequency, and related factors. The study will use Bayesian hierarchical modeling, clustering analyses, and causal discovery approaches to identify person-specific and group-level factors associated with pain interference.

Time Comparison of Interventions on Bowel Programs in Spinal Cord Injury

The goal of the study is to find out which of three different options (a suppository, a mini enema, or a transanal irrigation device) takes the least amount of time for completing bowel program amongst those who have spinal cord injuries with a neurogenic bowel. The main questions this study aims to answer are: * Does one of these tools meaningfully reduce the amount of time people with spinal cord injury need to complete their bowel programs? * Does one of these tools meaningfully reduce the number of times someone might experience incontinence or constipation? * Are participants satisfied in using these devices, and would they prefer to use the same tool at home? Researchers will compare the answers to these questions between the three different tools to improve quality of life for patients while improving the efficiency of the care provided. Participants in this study will: * Be enrolled in one of these options depending on when they are admitted to Casa Colina Hospital * Will receive the same tool for their bowel program for the majority or entirety of their stay * Will have a tracking sheet placed in their rooms for nursing to record when bowel program started and when it was completed * Will receive questionnaires when they enroll and when they finish the study on their experience with the tool and how likely they would be to use it at home

Patterns of Rehabilitation After Spinal Cord Injury

Patients with spinal cord injuries typically achieve a level of independence that allows them to return to their daily lives through an acute-phase rehabilitation program. However, in our country, it has been observed that many patients continue to make multiple hospital visits for rehabilitation purposes even in the later stages following a spinal cord injury, resulting in prolonged hospital stays. This situation negatively affects both the patients' social lives and their financial situations. Additionally, it places a burden on rehabilitation centers. The aim of this study is to examine the length of hospital stays and the time it takes for patients to return to their daily lives as they continue rehabilitation following a spinal cord injury.

Testosterone and Neural Function in Men With Spinal Cord Injury

Spinal cord injury (SCI) disrupts the nerves controlling movement, along with those that regulate functions like heart rate and blood pressure (known as the autonomic nervous system, or ANS). Testosterone (T) plays a significant role in brain health and ANS reflex function in non-neurologically impaired men. However, little is known about the relationships between T, nerve function, and ANS dysfunction after SCI. Interestingly, up to 60% of men with SCI exhibit persistently low T concentrations, which may worsen nerve and ANS dysfunction. In uninjured eugonadal people (normal physiologic range of serum T concentrations), a single pharmacologic dose of intranasal T has been shown to quickly improve nerve function, but no study has evaluated if T administration alters nerve and ANS function in men with SCI. Herein, the investigators will conduct the first study to test how a single dose of intranasal T impacts motor and ANS function in this population.

Robot-Assisted Intensive Physiotherapy in Individuals With Spinal Cord Injury

This randomized controlled trial aims to investigate the effects of robot-assisted intensive physiotherapy on trunk control, posture, and activities of daily living in individuals with spinal cord injury. A total of 52 participants will be randomly assigned to an experimental group or a control group. Both groups will receive 45-minute treatment sessions 7 days per week for 8 weeks. The experimental group will receive robot-assisted physiotherapy 3 days per week and trunk-focused conventional physiotherapy 4 days per week, whereas the control group will receive trunk-focused conventional physiotherapy 7 days per week. Participants will be evaluated at baseline, at the end of week 4, and at the end of week 8.

Leg Stretching Using an Exoskeleton on Demand for People With Spasticity

The purpose of this research study is to develop a protocol using a fully wearable, portable lower-limb exoskeleton for improving leg and walking function in people with movement disorders. The study investigates the effects of wearing the device during a set of experiments including leg stretching, treadmill walking and overground walking in muscle activity, joint motion, and gait performance. The goal is to develop an effective lower-limb strategy to restore lost leg function (e.g., range of motion) and gait ability, and improve quality of life in people with movement deficits following a neurological disorder.

The International Spinal Cord Injury Blood Biomarker Longitudinal Evaluation (I-SCRIBBLE) Study

To determine the accuracy of serum NF-L and GFAP levels (ie the biomarkers) at different time points postinjury for predicting the severity of neurologic impairment at 6 months postinjury as either motor complete (AIS grade A/B) or motor incomplete (AIS grade C/D) a group of patients who suffer traumatic spinal fracture and/or dislocation of the spinal column but without neurologic injury will be enrolled as non-SCI spine trauma control participants.

Reliability and Validity of the PReFS

This study is testing the psychometric properties of a new tool to determine recommendations for pressure relief frequency in wheelchair users.

PNS Motor Stimulation Study

Paralysis is one of the most disabling features of Spinal cord injury and stroke. In select cases, where the nerve is intact, stimulation can achieve meaningful muscle contraction e.g. to restore grip and release function. Previously, products to serve this purpose had been developed and successfully implanted (Freehand device). However, they had technical and cost limitations and have gone out of production. The investigators aim to investigate if a simple implantable and commercially available system could replicate the same function. Patients implanted with a wireless peripheral nerve stimulation (PNS) system for chronic pain in the upper limb shall be identified and approached for consent. Surface electromyography (EMG, baseline and with active contraction) shall be performed to confirm intact motor nerves. Baseline MRC (Medical Research Council Scale for Muscle Strength) grade shall be assessed. PNS shall be programmed to produce muscle contraction (within FDA approved safe limits for the device) with the EMG monitoring. The muscle contraction shall be recorded on video for further evaluation. Strength of contraction shall be assessed on the MRC scale. Stimulation parameters shall be then re-adjusted to pain-relief setting. Neurological examination shall be performed and return to baseline EMG ascertained. Data shall be analysed and the Study shall end when the data for the last participant is gathered.

The Effects of Eccentric Compared to Standard Strength Training in Primary Spinal Cord Injury Rehabilitation

The goal of this clinical trial is to assess the effects of eccentric arm-crank (KREHA) training compared to standard clinical routine strength (STAN) training in individuals undergoing primary spinal cord injury (SCI) rehabilitation. The main questions this trail aims to answer are: * what are the effects of the training on upper body strength, aerobic performance, muscle volume, functional independence, and health-related quality of life? * is the KREHA training feasible to implement into the rehabilitation routine? Participants will: * perform either 20 KREHA sessions or 20 STAN sessions within 12 weeks * perform a test battery to collect data on training effects before (pretest) and after (posttest) the study intervention

Modified Yoga for Pulmonary Function and Quality of Life in Spinal Cord Injury Patients

This pilot interventional study evaluated whether adding wheelchair-adapted Modified Yoga Therapy to conventional physical rehabilitation could improve pulmonary function, respiratory muscle strength, and quality of life in adults with traumatic thoracic spinal cord injury. Participants with operated traumatic thoracic spinal cord injury were assigned to either an experimental group or a control group. The control group received Conventional Physical Rehabilitation Therapy (CPRT), while the experimental group received CPRT together with a 20-minute Modified Yoga Therapy program, five days per week for four weeks. The yoga program included wheelchair-adapted postures, breathing exercises (Pranayama), and relaxation. Outcomes were assessed at baseline and after four weeks and included Peak Expiratory Flow Rate (PEFR), Maximum Inspiratory Pressure (MIP), and quality of life measured using the WHOQOL-BREF questionnaire. The study evaluated whether Modified Yoga Therapy could serve as an adjunct to conventional rehabilitation for individuals with thoracic spinal cord injury.

European Multicentre Study of Human Spinal Cord Injury

Today there is accumulating evidence from animal experiments that regeneration can be induced after a spinal cord injury (SCI). Consequently in the near future, new therapeutic approaches to induce some regeneration will be included in the treatment of patients with SCI. The aim of this proposal is to provide the required clinical basis for the implementation of novel interventional therapies. The establishment of combined clinical, functional and neurophysiological measures for a qualitative and quantitative assessment of spinal cord function in patients with SCI at different stages during rehabilitation represents a basic requirement to monitor any significant effect of a new treatment. Therefore, several European Paraplegic Centres involved in the rehabilitation of acute traumatic SCI patients build up a close collaboration for standardised assessment. The aim is to get knowledge about the natural recovery after spinal cord lesion in a larger population of patients in the sense of a historical control group and to bring new standardised assessment tools to the clinical setting.

Personal Exoskeleton or Manual Wheelchair: a Comparison of Performance and Satisfaction in Activities of Daily Living Among People With Spinal Cord Injuries, Using the SCED Methodology.

Spinal cord injuries resulting in paraplegia affect patients' mobility and, consequently, their ability to participate in activities of daily living. In France, according to available sources, the number of people with a symptomatic spinal cord injury is estimated to be between 97,000 and 132,000, with an average age of 55. The incidence is estimated at 1,300 new cases per year. Following initial treatment, patients' aim is to resume their daily activities. Engaging in these activities is associated with a better quality of life and is recognised as having a positive effect on health. Limitations in their ability to move around directly affect their participation in activities of daily living and, consequently, their quality of life. To this end, mobility can be supported by a manual wheelchair (MW) or an electric wheelchair (EW); however, these aids do not enable patients to regain the ability to stand, which remains one of the main goals for people with spinal cord injuries. Robotic exoskeletons can assist with standing and locomotion. To date, robotic exoskeletons have been used in rehabilitation centres. During the rehabilitation phase, these devices have proven to be usable and safe for a wide range of patients with spinal cord injuries. Motorised exoskeletons thus enable patients to perform tasks such as walking, standing upright, rotating, and carrying out dynamic balance exercises. In the longer term, personal exoskeletons, used at home, could facilitate the performance of productive, domestic, social or recreational activities, such as those carried out on a daily basis by every individual. Personal powered exoskeletons (PPEs) also appear to generate physiological and psychosocial benefits. Studies describe potential improvements in cardiovascular health, bladder and sphincter function, and a reduced risk of osteoporosis. After a few weeks of training with a motorised exoskeleton, patients report improvements in social functioning, mental health and sub-domains of general health perception on the SF36 Walk Wheel. It should be noted that the ability to interact socially whilst standing is an important aspect of quality of life for patients with spinal cord injuries. Patients describe the pleasure of eye contact, of being able to walk with assistance, and an improvement in mood. The PPE would complement the wheelchair by enabling ambulation and participation in activities whilst standing. Preserving upper limb function is a prerequisite for the widespread use of walking exoskeletons in everyday life. A self-supporting PPE, such as the EVE® device, which does not require the use of crutches, aims to enable users to stand up and walk whilst retaining the use of their upper limbs. This active balance control is a crucial function for achieving many functional skills in a domestic environment. One of the technological advantages of the self-balancing exoskeleton lies in the use of dynamics to eliminate the need for crutches, whilst ensuring walking safety. The next step towards the development of personal exoskeletons for people with spinal cord injuries is to investigate the performance of activities of daily living whilst wearing an exoskeleton. To our knowledge, no such study has been carried out, and our work addresses a gap in the scientific literature by analysing the impact of using a self-propelled PPE on satisfaction and performance when carrying out activities of daily living. The investigators hypothesise that the personal exoskeleton leads to greater satisfaction when carrying out the four tasks of daily living, compared with that achieved using a manual wheelchair. In this context, the KER-EXHOME clinical trial, proposed by Dr Stéphanie LEPLAIDEUR (coordinator of this study), and led by the Kerpape Centre (sponsor), aims to compare, in participants with paraplegia, satisfaction and performance when carrying out activities of daily living and physical activities, using the EVE® device compared with a manual wheelchair.

Xo-Motion R Exoskeleton in SCI-Adoption Study

After spinal cord injury (SCI), many people lose their ability to walk and do not have access to equipment and assistance that could help them regain functional abilities. Furthermore, many who have the potential to regain function are further hindered by a loss of function in their upper body that limits their ability to use a walker or crutches, thus eliminating options for mobility. This study seeks to determine the safety and feasibility of the XoMotion-R, a self-balancing exoskeleton that allows people with American Spinal Injury Association Impairment Scale (AIS) rating of B-D SCI to walk hands-free in inpatient and outpatient settings. This study will examine how use of the XoMotion-R affects functional outcomes and identify setting-specific barriers and facilitators to clinical adoption. This single-arm feasibility study will recruit 8 SCI inpatients and 8 SCI outpatients whose goal is to improve their walking and incorporate the XoMotion-R into their rehabilitation sessions. Participants will work on a variety of gait tasks tailored to their functional level. The goal is to determine whether early robotic gait training can improve functional outcomes and decrease length of stay, secondary complications, and long-term disability burden.

CBD for Lower Urinary Tract Dysfunction in Spinal Cord Injury

The goal of this feasibility study is to learn whether Cannabidiol (CBD) can improve urinary incontinence and other symptoms in people with recent spinal cord injury (SCI). Participants will take Epidiolex (purified CBD) for 90 days

Study on Preliminary Safety and Efficacy of Epidural Electrical Stimulation to Manage Lower Urinary Tract Dysfunction After Spinal Cord Injury

This clinical trial aims to assess the preliminary safety and efficacy of Epidural Electrical Stimulation (EES) therapy in managing lower urinary tract dysfunction in individuals with sub-acute or chronic spinal cord injury (SCI). The study evaluates the therapy's potential to improve urinary function and prevent neurogenic detrusor overactivity, ultimately seeking to enhance quality of life for individuals with SCI.

Digital Patient Engagement in Technology-Supported Neurorehabilitation

The goal of this observational study is to investigate digital patient engagement and its psychosocial correlates and potential predictors among adults aged 18-85 years with neurological disorders who are undergoing technology-supported neurorehabilitation using robotic systems for upper-limb training and/or virtual reality-based technologies. Specifically, the study will examine the roles of hope and the quality of the patient-healthcare professional relationship as the potential predictors of engagement with rehabilitation technologies. It will also explore the contribution of disease-management self-efficacy, technology anxiety, and sociodemographic, clinical, functional, and rehabilitation-related characteristics. Finally, the study will examine whether digital patient engagement predicts the perceived psychosocial impact of rehabilitation technologies, behavioural intention to continue using them, and overall satisfaction with the rehabilitation pathway. Participants will: * continue their standard neurorehabilitation pathway without any modification to routine clinical procedures; * complete a computerized self-report questionnaire via the Qualtrics digital platform at a single time point after completing at least three rehabilitation sessions using the technologies under study. No experimental intervention, comparison group, or follow-up assessment is planned.

GOAT (Gait Observation of Achilles Tendon)

The purpose of this study is to evaluate the mechanical properties of the Achilles tendon (stiffness, length, volume) and the force production capacities of the gastrocnemius medialis muscle in patients with spastic paresis (post-stroke or incomplete spinal cord injury) compared to healthy subjects, during gait.

mSCI: Mobile Health App for Veterans With SCI and Caregivers

Caregivers of persons with Spinal Cord Injury (SCI) face increased risk of psychological distress, health problems, reduced quality of life, relationship strain, and restrictions in social and work participation. Military caregivers (Family Caregivers of wounded or disabled Veterans) reported similar negative effects of becoming a caregiver on their physical and mental health. Using results from our previous work in mHealth interventions for individuals with SCI, we developed a dual-target intervention for both individuals with SCI and their caregivers. The overall objective of this research study is to conduct translational research focused on adapting and tailoring the interactive Mobile Health and Rehabilitation (iMHere) 2.0 system to meet the needs of Veterans with SCI and their family caregivers, expanding the psychosocial intervention, and evaluating the feasibility of implementing the iMHere system among Veterans with SCI and their family caregivers.

Safety and Feasibility of Intranasal Insulin in Patients With Spinal Cord Injury

The purpose of this study is to find out whether insulin, a drug approved by the FDA for the treatment of diabetes mellitus, is safe when administered as a nasal spray (intranasally) to people who have experienced a spinal cord injury. While insulin nasal spray has been shown to be safe in many patient populations, it has not yet been studied in people with spinal cord injury. This study would be the first step to developing insulin nasal spray as a treatment for spinal cord injury in the future. This study is recruiting up to 12 individuals who have experienced a spinal cord injury at least 4 months ago to administer either 76 IU insulin nasal spray or a placebo (inactive nasal spray) at home every day for up to 24 days. Participants will be asked questions about their health and symptoms related their spinal cord injury, and will have their blood collected throughout the study. Participants who are unable to administer the medication independently must have a study partner in order to participate.