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.

Addressing Spasticity and Motor Function With Epidural Spinal Cord Stimulation

The purpose of this study is to investigate treating severe spasticity in persons with spinal cord injury by implanting a device in the body that delivers electrical stimulation around the spinal cord (spinal cord epidural stimulation). This study will be closely monitoring a program designed to treat spasticity using an epidural stimulator to better understand its effects on spasticity and voluntary movement.

Cardiocentric Inotropic Optimization in Spinal Cord Injury

The first hours-to-day following acute traumatic cervical SCI represent a critical period of time to optimize hemodynamic management. After a spinal cord injury, cardiovascular function is affected. Maintaining blood pressure becomes is an important part of treatment as it supports recovery of the injured spinal cord. Blood pressure is most often increased using vasopressors, such as norepinephrine. Although these drugs help maintain blood flow, they may also lead to increased bleeding in the injury site, making the lesion worse. Alternatively, dobutamine, a medication that helps the heart pump more effectively, has shown to maintain blood pressure and improve prefusion at the injury site. This study will assess dobutamine capacity to maintain blood pressure acutely post injury.

Food Intake and Thermogenesis in High Spinal Cord Injury

The purpose of this research is to determine the effects of food on cardiovascular and metabolic health in men with and without spinal cord injury (SCI).

Exploring the Utility of [18F]3F4AP for Demyelination Imaging

The overall objective is to obtain an assessment of the pharmacokinetics of \[18F\]3F4AP in healthy volunteers and subjects with demyelinating diseases such as mild cognitive impairment (MCI), Alzheimer's Disease (AD), Multiple Sclerosis (MS), Spinal Cord Injury (SCI) and Spinal radiculopathy (SR).

The Effect of a Muscle-mimicking, Fabric-type Shoulder Orthosis on Functional Movements of the Upper Limb in Patients With Neuromuscular Disorder

The goal of this clinical trial is to investigate the effect of a muscle-mimicking, fabric-type shoulder orthosis on functional movements of the upper limb in patients with neuromuscular disorder. The main questions it aims to answer are: * What is the impact of the muscle-mimicking, fabric-type shoulder orthosis on upper limb functional movements in patients with neuromuscular disorder? * Are there observable differences in upper limb function when the shoulder orthosis is worn versus when it is not? Participants will: * Receive education on how to wear and use the shoulder orthosis. * Undergo evaluations, including assessment of upper limb performance, shoulder muscle strength testing, active range of motion measurements, assessment of functional workspace, goal attainment scale evaluation, surface electromyography, physiological measurements such as blood pressure and heart rate, fatigue assessment, and assessment for any musculoskeletal or skin-related issues. Researchers will compare neuromuscular disorder patients before and while wearing and operating the shoulder orthosis to see if there are any significant effects on variables such as upper limb function, range of motion, functional workspace, goal attainment scale, and surface electromyography.

Effects of CBD/CBD-A Oral Extract on Resting-state EEG and Neuropathic Pain Symptoms After SCI

The main purposes of this study are to (1) measure the effect of CBD/CBD-A on pain symptoms, pain intensity, pain unpleasantness, and skin sensitivity to hot and cold temperatures; and (2) measure the effect of CBD on brain electrical activity with electroencephalography (EEG).

NeuroRise: Intrathecal CE-1 Treatment for Traumatic SCI

The purpose of this study is to assess the safety and tolerability of intrathecal administration of CE-1 at a weight-based dose (cells/kg BW), capped at a maximum total dose of 1×10⁸ cells in 10 mL, with administered volume calculated using M = 0.167 mL/kg BW. Study details include: The overall study duration will be up to three years. The primary endpoint will be assessed at 6 months following investigational product administration. An additional secondary endpoint will be assessed at 12 months in the form of a phone call. Study visits therefore consist of one interventional visit, an evaluation visit within two weeks post-injection, a primary endpoint follow-up visit at 6 months, and a secondary endpoint follow-up phone call at 12-months.

Gut-Brain Neural Coupling in Spinal Cord Injury

The purpose of this research is to determine the effects of food on brain and stomach activity in persons with and without spinal cord injury (SCI).

FES-assisted Gait Training for Incomplete Spinal Cord Injury

Spinal cord injuries (SCI) impair neural communication, leading to difficulties in walking due to muscle weakness, altered reflexes, and impaired muscle activation below the injury. Functional electrical stimulation (FES) has been shown to enhance voluntary control, strength, and walking performance when used during gait training. This study aims to assess whether the FES yields superior improvements in walking ability compared to conventional gait training without stimulation.

Vagus Nerve Stimulation (VNS) in Spinal Cord Injury (SCI) Adaptive Follow-On Study

This study is an open label extension of the SCI EFS clinical trial (NCT04288245) that developed an innovative strategy to enhance recovery of motor and sensory function after neurological injury. The objectives of this study are to provide continued safety assessment for the investigational ReStore system, and to gain further estimate of the effect of Vagus Nerve Stimulation (VNS) with rehabilitative exercises in four different tracks - upper limb (UL), lower limb (LL), bladder control (BC), and sensory (SY) for participants with chronic SCI (Spinal Cord Injury).

Double Dose 4-AP on Functional Recovery After Spinal Cord Injury

The purpose of this study is to test a strategy to potentiate functional recovery of lower limb motor function in individuals with spinal cord injury (SCI). The FDA approved drug, Dalfampridine (4-AP). 4-AP will be used twice-daily in combination of Spike-timing-dependent plasticity (STDP) stimulation and STDP stimulation with limb training.

Home-Based Heat Therapy in Spinal Cord Injury to Improve Cardiovascular Health

The study is designed to investigate the effects of passive heat therapy on blood vessel health in 40 people (48 enrolled with attrition rate of 20%). Following an extensive set of vascular function tests, participants will engage in either a passive heat therapy intervention for 60 minutes, 4 times a week for 8 weeks, or a placebo intervention at a lower temperature. Seven of the 8 weeks of intervention will occur in the home setting. Vascular function tests will be repeated after the 8 weeks to determine if chronic passive heat stress improved vascular health.

ECoG BMI for Motor and Speech Control

Test the feasibility of using electrocorticography (ECoG) signals to control complex devices for motor and speech control in adults severely affected by neurological disorders.

A Novel Repetitive Synchronized Associative Stimulation Neuromodulation Approach for Spinal Cord Injury Patients

The purpose of this research is to explore the effect of magnetic stimulation to activate the brain, electrical spinal cord stimulation to activate spinal cord, and electrical muscle stimulation used to activate upper limb (arms), lower limb (legs) and trunk (stomach) muscles in people with spinal cord injury (SCI) and able-bodied subjects (without SCI).

ARC-IM Therapy To Support and Promote Recovery of Ambulatory Functions in People With Subacute and Chronic Spinal Cord Injury

The EIGER study aims to evaluate the safety and preliminary efficacy of ARC-IM Therapy (Epidural Electrical Stimulation) to support and promote recovery of ambulatory functions, such as walking, in people with subacute and chronic spinal cord injury.

Epidural Stimulation After Neurologic Damage: Long-Term Outcomes

This study will evaluate the long-term effect of chronic spinal cord stimulation to restore volitional movement for patients with chronic spinal cord injuries.

SCS Therapy for Patients With Bladder and Bowel Dysfunction After SCI

This clinical trial aims to evaluate the safety and efficacy of spinal cord stimulation (SCS) in treating patients with urinary and bowel dysfunction after spinal cord injury (SCI). SCI is a highly disabling condition that can lead to sensory, motor, and autonomic nervous system dysfunction below the injury level. Neurogenic bladder and bowel dysfunction are common sequelae of SCI, seriously affecting patients' quality of life. Currently, clinical treatments can only partially alleviate urinary and bowel dysfunction, and more effective therapeutic approaches are still needed. Existing clinical studies have shown that SCS is gradually being applied to treat neurogenic bladder and bowel dysfunction in SCI patients. SCS can significantly improve urinary efficiency, bladder capacity, compliance, and detrusor pressure in SCI patients, thereby enhancing their quality of life. The main questions this study aims to answer include: 1. Can this protocol help patients restore partial urinary and bowel function? 2. Besides the restoration of partial urinary and bowel function , can the SCS therapy could also help patients to restore the walking function. Patients with urinary and bowel dysfunction more than 6 months after spinal cord injury will undergo epidural spinal stimulation electrode implantation surgery two weeks after functional assessment. Then the parameter optimization and rehabilitation will last for 6 months. The follow-up records and assessments will be conducted monthly at 2, 4, and 6 months after surgery.

Nutrition and Pain Study

The purpose of this research is to assess the effectiveness of a nutrition intervention on diet quality in managing pain in individuals with spinal cord injury (SCI).

The Utilization Effects of Powered Wearable Orthotics in Improving Upper Extremity Function and ADL in Persons With SCI

To evaluate the usefulness of an upper extremity assistive device, called (MyoPro) in improving upper extremity activities in people with incomplete spinal cord injury. The Department of Defense is supporting this study.

Augmented Reality BCI Longitudinal Study for Persons With ALS, Stroke, TBI and SCI Utilizing Cognixion + Apple Vision Pro

The goal of this study is refine the usability of a BCI capable communication platform. The study will take place in the United States area and will enroll up to 10 participants with late stage ALS, traumatic brain injury (TBI) or spinal cord injury (SCI) that have assistive communication and computer control needs. Each subject will receive an integrated Cognixion + Apple Vision Pro device that includes an augmented reality brain computer interface and associated communication software. The study duration is 3-4 months for each participant. The key questions that will be addressed in this study are: 1. Identify the ability of individuals with target indications to use the integrated Cognixion-Apple Vision Pro system to communicate effectively. 2. Identify the ability of such individuals to learn to use BCI, ET-BCI and other modalities, and to measure their progress over time. 3. Identify the effectiveness of the different forms of input supported by the combined Cognixion-Apple Vision Pro system (BCI, eye-tracking) in allowing such individuals to communicate and have agency. 4. Identify how input such as BCI can be optimized to suit the needs of individuals (e.g., specific frequencies that work best for an individual, SNR with different frequencies, number of targets, length of recording for each frequency) and improve overall usability. 5. Identify the extent to which personalization through a large language model (LLM) affects communication. 6. Identify the appropriate capabilities to enable through an agentic communication interface. Key measures include: ITR - information transfer rate SUS - system usability scale

Near-Infrared Imaging of Motor Imagery Effects in Spinal Cord Injury

The primary objective of this clinical trial is to investigate the efficacy of motor imagery-based brain-computer interface (MI-BCI) technology in improving motor function among patients with spinal cord injury (SCI), as well as its impact on cortical motor area function across varying states. To achieve this, the study will implement MI-BCI intervention in SCI patients, evaluate post-treatment motor function improvements, and assess changes in cortical motor area oxygen metabolism (via functional near-infrared spectroscopy, fNIRS) and neural activity (via electroencephalography, EEG). The ultimate goal is to establish a novel rehabilitation strategy for SCI. Specifically, the trial aims to: (1) determine whether MI-BCI effectively enhances motor function in SCI patients; and (2) clarify the differential effects of MI-BCI on cortical motor area function under distinct states (e.g., resting vs. task-performing) in this population. Participants will be randomly assigned to one of two groups: the experimental group will undergo MI-BCI training, while the control group will receive active cycling training (as a conventional rehabilitation control). Both interventions will be structured as 20-minute sessions, administered 5 days per week, over a total of 4 weeks.Pre- and post-treatment assessments will include: lower limb motor function (measured by the Lower Limb Motor Score), activities of daily living (evaluated via the Modified Barthel Index), walking capacity (quantified using the Spinal Cord Injury Walking Index), and cortical motor activity (captured through fNIRS and EEG measurements).

Long-term Follow-up for Epidural Stimulation in SCI

The goal of this study is to understand long-term effects of spinal cord stimulation in individuals who have a spinal cord injury. The main aims are to: 1. provide support for those with epidural stimulators who choose to continue stimulating because they deemed them to improve their quality of life 2. provide additional sites for follow-up so that the financial burden can be minimized for the research participants to travel 3. collect long-term safety data; and 4. when feasible collect data to understand the sustainability of outcomes. Participants will: * receive stimulation programs and software for the activities and/or functions completed in the previous study and demonstrate to the research staff that I can conduct them without their help to use at home * continue using the stimulation programs at home as directed by the research staff * return to Kessler Foundation for a follow-up visit (approx. 2 hours) with assessments at 6 months, 1 year, and once a year after enrolled in the follow-up study last until either the device is turned off, removed or the device is commercially approved.

Improving Balance After Spinal Cord Injury Using a Robotic Upright Stand Trainer and Spinal Cord Epidural Stimulation

The purpose of this study is to understand how standing and sitting balance control is altered after spinal cord injury and how a new type of robotic assistive device may be used with spinal stimulation to improve muscle function. The investigators will be testing a device called the Tethered Pelvic Asist Device (or "TPAD") in this study. The TPAD may be helpful in two ways. It can be used to help control and support of the trunk, pelvis, and knees during stand training. Also, the TPAD can be used as a training tool by providing controlled "pushes" or "perturbations" that must be corrected by the person with spinal cord injury in order to maintain proper posture and upright balance. This could be helpful for improving muscle function after spinal cord injury. Participants will be placed into one of two groups based on availability and preference. Group 1 will receive TPAD training with stimulation and assessments with and without stimulation. Participation in this group lasts approximately 4 months. Group 2 will only receive assessments with and without stimulation. Participation in this group last approximately 3 weeks.