Clinical Research Directory

At-Home Genital Nerve Stimulation for SCI Bowel

The purpose of this study is to test whether electrical stimulation of the skin in the pelvic area (near the genitals) can reduce the reflexes that cause bowel accidents in people with spinal cord injuries. Current bowel treatments either involve diet and medications or surgery. This study will evaluate whether electrical stimulation can be an alternate option for bowel management. Researchers will: * Use an FDA approved Transcutaneous Electrical Nerve Stimulation (TENS) device off-label * Compare a target stimulation level to a placebo stimulation level Participants will: * Use electrical stimulation on the skin in the pelvic area for 6-8 hours each day for 4 weeks at home * Visit the research center 3 times to participate in exams and answer questions * Keep a daily diary of their bowel symptoms and stimulation times

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.

Influence of Transcranial Electrical Stimulation on Arm and Hand Function After Cervical Spinal Cord Injury

The goal of this pilot study is to find out how four different types of transcranial electrical stimulation (tES) affect brain activity, the process of acquiring new skills (also called motor learning), and hand function after cervical spinal cord injury (cSCI). Participants will complete 5 study sessions: one sign-up session and four testing \& intervention sessions. Total participation will take about 18 hours. During the sign-up session, researchers will: discuss study details, review the participant's health history to make sure that it is safe for them to participate, perform tests to ensure that the participant meets the study criteria, and collect the participant's demographic information. During each testing \& intervention session, the participant will receive a different type of tES. Before and after getting tES, they will take part in tests that measure their brain activity and the strength, sensation, and function of their right hand.

Understanding and Enhancing Human Health and Movement

By doing this study, investigators hope to learn how electrical stimulation can improve human movement, biomechanics, and function and to gather information on the safety and effectiveness of an implanted electrical stimulation system after paralysis from spinal cord injury, stroke, multiple sclerosis, and traumatic brain injury.

Effect of TMS on Neuropathic Pain for Patients With Spinal Cord Injury

Patients will be randomly assigned to three groups using a randomization scheme: active primary motor cortex (M1) rTMS, active anterior cingulate cortex (ACC) rTMS, or sham M1 rTMS. Stimulation will be delivered using a Magstim Rapid2 Magnetic Stimulator (Magstim, Whitland, UK) with figure-of-eight active and sham coils or a double-cone coil, depending on the treatment group. All patients will receive 10 sessions of 5 Hz rTMS over two weeks under physician supervision. Stimulation intensity will be set at 90% of the resting motor threshold (RMT), determined from the contralateral first dorsal interosseous muscle following stimulation of the dominant hemisphere. Each session will consist of 10 trains of stimulation separated by 50-second intervals, delivering a total of 500 pulses. All patients will continue their conventional physical therapy programs throughout the study.

Treating Central Neuropathic Pain With Low Dose Naltrexone for People With Spinal Cord Injury

The goal of this pilot clinical trial is to find out how well low dose naltrexone works for people with pain due to spinal cord injury. The main questions it aims to answer are: will low dose naltrexone reduce pain, and increase the quality of life for people with central neuropathic pain due to spinal cord injury. Hypothesis 1: LDN will decrease the severity of CNP in adult patients with SCI as measured by the Neuropathic Pain Scale (NPS) Hypothesis 2: LDN will improve quality of life of patients with SCI as measured by various validated clinical tools There is no comparison group. This study is being completed to give investigators more information for how to best run a larger clinical trial. Participants will be asked to take an oral dose of 4.5mg of naltrexone, daily, for 12 weeks.

tSCS Combined With Rehabilitation Training in Treating Paraplegic Patients After SCI

This clinical trial aims to evaluate the safety and efficacy of transcutaneous spinal cord stimulation (tSCS) combined with rehabilitation training for treating paraplegia after spinal cord injury (SCI). Previous studies have shown that applying tSCS in the thoracolumbar region can enable patients with complete and incomplete SCI to immediately restore partial voluntary movement, but there are currently no domestic reports on the treatment of SCI paraplegia using tSCS combined with rehabilitation training. The main questions this study aims to answer include: 1. Compared with using tSCS alone, does combined rehabilitation therapy enable patients to better restore voluntary movement? 2. Will this treatment protocol result in fewer adverse events? 3. Can the tSCS combined with rehabilitation training protocol be applied to a large number of patients with paraplegia after SCI to help them restore voluntary movement?For paraplegic patients with SCI (spinal cord injury) whose injury duration exceeds 1 week, baseline data (pre-stimulation, at the end of the first week of stimulation, and post-experiment) need to be collected after assessment. After adjusting the stimulation parameters of tSCS (transcutaneous spinal cord stimulation) and modifying the rehabilitation training plan, a one-month personalized rehabilitation training program will be conducted, followed by at least four weeks of follow-up. Researchers will compare the assessment results recorded at different stages and use specific indicators to evaluate the safety and effectiveness of this treatment protocol.

Informational Needs of Caregivers of Patients With Neuromotor Disease in Rehabilitation Hospitalization: Validation Study of the QBI-R/V

Background and rationale. Although the literature suggests that caregivers have different needs at various stages of the patient's illness, to date, most studies have focused only on the needs of caregivers of patients with specific diseases or during specific periods of the illness trajectory, and have not explored changes in caregivers' needs throughout the entire neuromotor recovery process, from admission to discharge in rehabilitation wards. In a patient-centered care perspective, it is important not only to explore the informal experiences of patients and caregivers regarding outcomes and consequences of the transition from hospital to home, but also their perspectives on interventions that would support them in self-management. In this context, this study represents the next phase of a qualitative study that identified the underlying dimensions of caregivers' informational needs, essential for constructing a measurement tool that allows both qualitative and quantitative assessment of these needs. The tool would make it possible to identify, upon patient admission to rehabilitation, the essential informational needs in order to address them during hospitalization. The same items would also serve to assess the response obtained, in terms of healthcare service quality, before discharge. Study design. Experimental with low level of intervention. Objectives. The study aims to validate a questionnaire specifically developed to detect and assess the informational needs of caregivers of neurological patients during rehabilitation hospitalization (post-acute phase). Endpoint. Creation of a reliable and valid tool for detecting the informational needs of caregivers of neurological patients during rehabilitation hospitalization.

Extracorporeal Shockwave Therapy as an Additional Treatment for Spasticity Secondary to Spinal Cord Injury

Spasticity is a common consequence of spinal cord injury and can have a profound impact on quality of life. The goal of this study is to learn if an intervention called focused extracorporeal shockwave therapy can enhance the effectiveness of injections received for spasticity, such as Botox. The main questions this study seeks to answer are whether shockwave therapy and toxin injection 1) can improve spasticity symptoms greater than toxin injection alone, and 2) change the structure of the injected muscles. Researchers will compare the group who receives both shockwave therapy and toxin injection to a group who receives only toxin injection. Participants will be asked to visit the clinic five times over the span of three months. The first three visits will occur on three consecutive weeks, during which participants will receive shockwave therapy or the sham therapy. The final two visits will occur four and eight weeks later, during which participants will be asked a series of questions about their spasticity and have ultrasounds and MRIs collected of their leg muscles.

Recovery and Safety After Epidural Spinal Cord Stimulation in People With Spinal Cord Injury

Spinal cord injury can cause lasting difficulties with movement, sensation, bladder and bowel function, and daily activities. Epidural spinal cord stimulation delivers electrical pulses through implanted electrodes and may be used together with rehabilitation to support recovery. This retrospective case series will review clinical records from six patients with spinal cord injury who previously received implanted epidural spinal cord stimulation at Haikou People's Hospital. Three of the patients are children. The study aims to describe changes in movement, sensation, standing and walking ability, daily activities, and other functions, as documented in the available records. It will also summarize complications related to implantation, the stimulation system, and stimulation during follow-up. The research involves reviewing existing treatment and follow-up information. Participation in this retrospective study does not require a new implantation procedure or changes to the patient's treatment.

Effects of Functional Electrical Stimulation on Spasticity, Quadriceps Muscle Strength and Functional Mobility in Individuals With Paraplegia

Spinal cord injury (SCI)-related paraplegia is a complex neurological condition characterized by motor impairment, increased spasticity, and significant functional limitations in daily activities. Spasticity is one of the most common secondary complications after upper motor neuron lesions and can negatively affect rehabilitation outcomes, gait ability, and functional independence. This randomized controlled study aims to investigate the effects of Functional Electrical Stimulation (FES) applied to the quadriceps muscle in individuals with paraplegia. Brief Summary This randomized controlled trial aims to investigate the effects of Functional Electrical Stimulation (FES) applied to the quadriceps muscle in individuals with paraplegia. Individuals included in the study will be divided into three groups: control group, FES application group, and Sham group. The control group will receive only a standard neurological rehabilitation program, while the FES group will receive Functional Electrical Stimulation to the quadriceps muscle in addition to the FES program. The Sham FES group will receive Conventional neurorehabilitation + sham/placebo FES. The primary outcomes include changes in spasticity level, quadriceps muscle strength, and functional mobility. Spasticity will be assessed using the Modified Ashworth Scale (MAS), muscle strength will be evaluated with Manual Muscle Testing (MMT), and functional mobility will be measured using the Spinal Cord Independence Measure (SCIM), Timed Up and Go Test (TUG), and 6-Minute Walk Test (6MWT). The intervention period will last 8 weeks, with standardized rehabilitation programs applied to both groups. The FES group will additionally receive quadriceps stimulation with specific neuromuscular electrical stimulation parameters. The findings of this study are expected to provide evidence regarding the effectiveness of FES as an adjunct to conventional rehabilitation in improving motor function and functional independence in individuals with paraplegia.

Comparison Between Objective Biomechanical Cost and Perceived Physical Demand in Manual Wheelchair Users During Propulsion Tasks

Wheelchair users must be able to move around freely and access public buildings and transport, but current accessibility standards (e.g. maximum 8% ramp slope) are based on limited scientific evidence about the real biomechanical and perceived difficulties encountered by manual wheelchair users in daily life. Manual wheelchair propulsion is not purely a motor activity: it also involves cognitive and emotional demands (attention, trajectory planning, stress and frustration management) that contribute to a mental workload. This cognitive dimension is still rarely integrated into biomechanical evaluation protocols. This exploratory (pilot) study aims to test the feasibility of a protocol combining objective biomechanical data (shoulder joint loading estimated from motion capture and instrumented handrims) with the subjective experience of participants (perceived physical demand from the NASA-TLX questionnaire, perceived exertion from the Borg scale), during standardized and more realistic manual wheelchair propulsion tasks, including tasks performed under an added cognitive load (auditory-verbal 2-back dual task).

A Neuroprosthesis for Seated Posture and Balance

The purpose of this study is to evaluate a surgically implanted functional electrical stimulation (FES) system to facilitate stability of the trunk and hips. FES involves applying small electric currents to the nerves, which cause the muscles to contract. This study evaluates how stabilizing and stiffening the trunk with FES can change the way spinal cord injured volunteers sit, breathe, reach, push a wheelchair, or roll in bed.

Implementing a Decision Support Tool to Prevent Community-Acquired Pressure Injury in Spinal Cord Injury (SCI) in the Spinal Cord Injury Clinic

Spinal cord injury (SCI) is a permanent condition affecting every aspect of life including health, daily activities, and participation and quality of life. Persons with SCI are at high risk of pressure injury (PrI) throughout their lives due to loss of sensation, nerve damage and immobility. PrIs are local areas of damage to the skin and underlying soft tissue caused by pressure and shear commonly located over bony prominences. While most PrIs are hospital- or nursing home-acquired, in people with SCI, PrIs typically develop in the community. Community-acquired pressure injuries (CAPrIs) are common, devastating, and costly. This grant proposal will assess how well a decision support tool, called the Community Acquired Pressure Injury Prevention Field Implementation Tool (CAPP-FIT), is used in the clinic and how well it prevents CAPrIs. The CAPP-FIT will be implemented at seven sites across the country in a staggered fashion. The CAPP-FIT includes: 1) an automated Veteran survey to identify risks, actions, and resources needed to prevent CAPrIs and 2) a companion Provider Report immediately available in the electronic health record listing Veteran responses to survey items with recommended evidence-based provider actions. The Veteran survey can be completed via a secured email on the computer or phone. There are three aims in the proposal: Aim 1 is implementing the CAPP-FIT at the seven geographically diverse VA SCI clinics. After CAPP-FIT implementation, each site will determine how the CAPP-FIT will be maintained in clinical practice to support sustainability. Aim 2 assesses how well the CAPP-FIT prevents CAPrIs and CAPrI-associated hospitalizations and assesses provider and Veteran satisfaction. Aim 3 assesses how well the CAPP-FIT is implemented in the SCI clinic.

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.

Transcutaneous Spinal Cord Stimulation for Neurorehabilitation After Spinal Cord Injury

This pilot controlled study aims to evaluate the clinical and instrumental effects and feasibility of transcutaneous cervical spinal cord stimulation (tSCS) combined with conventional rehabilitation in adults with spinal cord injury (SCI). A total of 20 participants will be enrolled and assigned to two parallel groups. The experimental group will receive conventional rehabilitation combined with transcutaneous cervical spinal cord stimulation using the ExaStim® system, while the control group will receive conventional rehabilitation alone. In the experimental group, stimulation will be delivered twice weekly for 4 weeks, for a total of 8 sessions. The study will primarily explore the immediate effects of a single stimulation session on motor control and muscle tone. It will also assess changes in motor function, muscle tone, and clinical, robotic, and electrophysiological measures over the 4-week intervention period, as well as feasibility, tolerability, and adverse events. Comparisons between the experimental and control groups will be exploratory, consistent with the pilot nature of the study.

Augmenting Upper Limb Function and Functional Neuroplasticity Using Epidural Stimulation of the Cervical Spinal Cord

This study will test whether spinal stimulation combined with rehabilitation can improve arm and hand function in people with tetraplegia after spinal cord injury. Tetraplegia causes weakness or paralysis in the arms and legs. The stimulation sends electrical pulses through a paddle placed near the spinal cord in the neck. Researchers will study changes in arm and hand function and how the brain and spinal cord respond. The study has two phases. \*\*Phase 1: Initial testing\*\* Participants will: * Complete screening to see whether they qualify. * Have surgery to place a stimulation paddle in the neck, with wires extending outside the body. * Take part in arm and hand exercises with spinal stimulation. * Complete tests to measure their response. The study team will check whether each participant meets the criteria to continue. Those who qualify may choose to enter Phase 2. Those who do not qualify will have the paddle and external wires removed and will not enter Phase 2. \*\*Phase 2: Permanent implant\*\* Participants will have surgery to implant a battery that powers the stimulation system. They will continue arm and hand exercises with stimulation. The study team will adjust the settings to support each participant's movement goals.

Fermented Foods and Bowel Health in SCI

The goal of this clinical trial is to learn whether consuming a high fermented food diet improves bowel function and gut health in adults with chronic spinal cord injury (SCI). The study will also evaluate the feasibility and tolerability of consuming fermented foods daily for 10 weeks. The main questions it aims to answer are: 1. Does a high fermented food diet improve neurogenic bowel dysfunction symptoms and colonic transit in adults with SCI? 2. Does fermented food intake change gut microbiome composition, short-chain fatty acid production, and intestinal inflammation? Researchers will compare a high fermented food diet to a control diet to evaluate effects on bowel health and gut microbiome outcomes. Participants will: * Consume study foods daily for 10 weeks * Attend 2 in-person study visits * Collect stool samples at home and ship them overnight to the research team using provided collection kits and prepaid shipping materials * Complete bowel health questionnaires and dietary recalls * Undergo Sitz marker testing with abdominal X-rays to assess colonic transit * Participate in biweekly monitoring contacts throughout the study period

Shockwave for Elbow and Wrist Spasticity in People With Spinal Cord Injury

Approximately 305,000 people live with a spinal cord injury (SCI) in the United States. Sixty percent of these individuals have tetraplegia, which can cause significant dysfunction of the arms and hands. One of the consequences of SCI is spasticity - involuntary activation of muscles that can hinder bodily functions and negatively affect participation in various aspects of life. Spasticity can lead to loss of functional independence and activity limitations, cause pain, and lead to mood disorders like depression. It can even interfere with rehabilitation and lead to hospitalization. In people with tetraplegia, spasticity of the arms and hands can have a tremendous impact on independence and quality of life, and thus regaining function in these areas remains a top priority. Unfortunately, spasticity is difficult to treat. Common treatments include physical therapy, including exercise or stretching; medications such as Baclofen; and injections with agents like botulinum toxin (also known as Botox). Botox injections are often implemented alongside other modalities like therapy, yet they are invasive, tend to last for only a few months, and carry potential side effects. One potential non-invasive treatment for upper limb spasticity is focused extracorporeal shockwave therapy (f-ESWT), which involves an external application of high-pressure sound waves, similar to ultrasound. An applicator/handpiece is placed on the skin over the spastic muscle and the focused sound waves are applied. f-ESWT carries no long-term side effects with minimal discomfort during application. However, there has been limited research on this treatment option in people with SCI who have arm and hand dysfunction caused by spasticity. The purpose of this study is to fill in that knowledge gap. This will be accomplished by measuring different aspects of spasticity from the perspective of both the clinician and the person with SCI. These will include clinical measures, such as elbow and wrist range of motion, as well as how the treatment impacts the person's functional independence and quality of life. Ultrasound methods will be used to look at the person's muscles to see if any beneficial changes occur in their structure and stiffness. People with SCI who meet eligibility criteria will be invited to the laboratory to receive f-ESWT, which will occur once per week for three consecutive weeks. Treatment will entail application of f-ESWT to the elbow and wrist flexor muscles. Participants will be invited back to the laboratory to have their spasticity measured by a clinician, be asked questions about how their spasticity has impacted their lives, and have their muscles imaged with ultrasound. Findings from this study are expected to generate insight on whether f-ESWT could be a viable treatment option for spasticity of the arms and hands in people with SCI, and if a larger clinical trial is warranted.

Olfactory Cell Transplantation and Intensive Rehabilitation to Repair Chronic Spinal Cord Injury

This is a randomised, blinded and controlled Phase I trial to measure the safety, feasibility and efficacy of a combined cell transplantation and intensive rehabilitation intervention to treat spinal cord injury. The trial aims to examine whether transplantation of olfactory cell nerve bridges combined with intensive rehabilitation is safe and feasible for people living with chronic spinal cord injury in Australia, and whether the intervention improves structural integrity of the spinal cord, functional recovery, overall health, and social wellbeing. For the olfactory cell nerve bridge transplant, cells from inside the patient's own nose will be purified and engrafted as 3D cellular nerve bridges. Participants will receive a dose that is dependent on the size of the accessible space within the injury site of the spinal cord with up to 60 million cells being engrafted. The surgery for the transplantation will be performed by a neurosurgeon in which the spinal cord will be exposed to enable the nerve bridges to be placed into the injury site. The duration of the procedure will be 3-4 hours. Surgical notes will be used to monitor adherence to the protocol. For intensive exercise rehabilitation, the intervention will be supervised and provided by physiotherapists and exercise physiologists at a for-purpose neurorehabilitation facility. The mode of administration will be one-on-one sessions. The 12- and 32-week rehabilitation programs will consist of up to 3 hours per day at the rehabilitation service providers, for 5 days per week. Participants will attend the provider that is within their geographical area. Over each week, sessions will involve a range and mix of activities which could include, but are not limited to, standing, gait training, upper limb strength, trunk stability/core strength, and aerobic training. Throughout the trial, logs of exercise activities will be completed by the participants and staff at the neurorehabilitation gyms. Rehabilitation will start from day 1 of the priming rehabilitation (PR) program and go for 12 weeks, then surgery and cell transplantation will occur at week 1 of the cell transplantation surgery and recover program which is 2 weeks post conclusion of Priming Rehabilitation (PR), followed by 5 weeks of recovery. Rehabilitation is for 32 weeks starting 6 weeks post transplant surgery. Regenerative rehabilitation program is from weeks 1-32 of the regenerative rehabilitation (RR) program. If nerve bridge production fails for whatever reason in the weeks prior to surgery, this will start an extension/contingency/alternative timeline, where a new nasal biopsy will need to be taken from the participant (along with accompanying tests). The cells will be grown up over the next 4 weeks with an additional week of nerve bridge production, while the participant engages in a further five weeks of priming rehabilitation.

Effect of Neuro20 Functional Electrical Stimulation Suit on Autonomic Function, Muscle Performance, and Gait

This research aims to understand the effect of the Neuro20 Functional Electrical Stimulation Suit on autonomic nervous system function, muscle performance, and gait after amputation or neurologic injury.

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.

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

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.