Spinal Cord Injury clinical trials at University of California Health
19 in progress, 11 open to eligible people
BrainGate2: Feasibility Study of an Intracortical Neural Interface System for Persons With Tetraplegia
““Turn thoughts into action” for people living with paralysis”
open to eligible people ages 18-80
The purpose of this study is to obtain preliminary device safety information and demonstrate proof of principle (feasibility) of the ability of people with tetraplegia to control a computer cursor and other assistive devices with their thoughts.
at UC Davis
Canadian-American Spinal Cord Perfusion Pressure and Biomarker Study
open to eligible people ages 17 years and up
This multicenter study will enroll 100 patients with acute traumatic cervical and thoracic SCI who have a lumbar intrathecal catheter inserted within 24 hours of their injury. The lumbar intrathecal catheter will be inserted pre-operatively for the measurement of ITP and the collection of cerebrospinal fluid (CSF) samples. SCPP will be calculated as the difference between MAP and the ITP. There are two important distinct yet related objectives in this prospective interventional study. 1. Determine the effect of SCPP maintenance ≥ 65 mmHg in acute SCI on neurologic recovery as measured by ASIA Impairment Scale (AIS) grade conversion and motor score improvement. 2. Collect CSF and blood samples for the measurement of neurochemical biomarkers and storage for future biomarker discovery and validation studies.
at UCSF
Closed-Loop Deep Brain Stimulation for Refractory Chronic Pain
open to eligible people ages 22-80
Chronic pain affects 1 in 4 US adults, and many cases are resistant to almost any treatment. Deep brain stimulation (DBS) holds promise as a new option for patients suffering from treatment-resistant chronic pain, but traditional approaches target only brain regions involved in one aspect of the pain experience and provide continuous 24/7 brain stimulation which may lose effect over time. By developing new technology that targets multiple, complimentary brain regions in an adaptive fashion, the investigators will test a new therapy for chronic pain that has potential for better, more enduring analgesia.
at UCSF
ECoG BMI for Motor and Speech Control
open to eligible people ages 21 years and up
Test the feasibility of using electrocorticography (ECoG) signals to control complex devices for motor and speech control in adults severely affected by neurological disorders.
at UCSF
BrainGate2 Neural Interface System in Persons With Tetraplegia (BG-Speech-02)
open to eligible people ages 18-80
The goal of this study is to improve our understanding of speech production, and to translate this into medical devices called intracortical brain-computer interfaces (iBCIs) that will enable people who have lost the ability to speak fluently to communicate via a computer just by trying to speak.
at UC Davis
Improving Bladder Function in SCI by Neuromodulation
open to eligible males ages 18-45
This trial will investigate the safety and utility of spinal cord neuromodulation to improve urinary bladder function in the context of spinal cord injury.
at UCLA
Neuromodulation to Improve Respiratory Function in Cervical Spinal Cord Injury
open to eligible people ages 18-75
This is a phase 1 study of safety and feasibility of cervical spinal cord stimulator implantation in cervical SCI subjects who are ventilator dependent. The Investigators will be focusing on the safety and feasibility of this approach. Participants may qualify for the study if they are male or female 18-75 years old, are at least 1 year after original injury, have injury at C2 to C7 level, and dependent on mechanical ventilation to help them breathe. Additionally, they need to be able to attend up to twice weekly testing sessions for up to 21 months.
at UCLA
Spinal COrd NeuromodulaTor by SpIneX and ScoNE to Treat NeurogeniC BladdEr - SCONE "CONTINENCE" Clinical Study
open to eligible people ages 18-75
The purpose of this study is to evaluate the effectiveness and safety of SCONE neuromodulation therapy after 12 weeks of therapy in comparison to inactive sham control in improving symptoms of Neurogenic Lower Urinary Tract Dysfunction
at UCSD
Telenutrition for Individuals With SCI
open to eligible people ages 20 years and up
This study will provide nutrition counseling via FaceTime on an iPad to persons with traumatic spinal cord injury (SCI) who are overweight or obese and are at least one-year post-injury. Nutrition counseling may help participants to develop eating behaviors that match the participants' needs and help improve heart health. The purpose of this project is to decrease the risk of complications like obesity, high cholesterol, or diabetes, and explore associations between bowel and bladder function and nutrition. This study will require 3 in person visits that are about 3 months apart. The total length of the study is about 6 months and includes 3 months of telenutrition counseling.
at UCSF
Telerehabilitation Early After CNS Injury
open to eligible people ages 18 years and up
The goal of this clinical trial is to assess the safety and feasibility of providing extra doses of rehabilitation therapy for persons with a recent stroke, traumatic brain injury (TBI) and/or spinal cord injury (SCI). The therapy treatment targets to improve arm function by introducing telerehabilitation to the bedside of participants during the inpatient rehab admission period. Participants will use a newly developed functional training system (HandyMotion) to access therapy treatment program directly from their hospital room. HandyMotion is a sensor-based training system that can connect to the TV set in the hospital room, enabling patients to access their therapy training program to practice rehab-oriented games and exercises ad libitum, at any time of the day.
at UCLA
Transcranial Magnetic Stimulation for Chronic Neuropathic Pain
open to eligible people ages 18-80
Chronic neuropathic pain is defined as pain caused by a lesion or disease of the somatosensory nervous system. It is highly prevalent, debilitating, and challenging to treat. Current available treatments have low efficacy, high side effect burden, and are prone to misuse and dependence. Emerging evidence suggests that the transition from acute to chronic neuropathic pain is associated with reorganization of central brain circuits involved in pain processing. Repetitive transcranial magnetic stimulation (rTMS) is a promising alternative treatment that uses focused magnetic pulses to non-invasively modulate brain activity, a strategy that can potentially circumvent the adverse effects of available treatments for pain. RTMS is FDA-approved for the treatment of major depressive disorder, obsessive-compulsive disorder, and migraine, and has been shown to reduce pain scores when applied to the contralateral motor cortex (M1). However, available studies of rTMS for chronic neuropathic pain typically show variable and often short-lived benefits, and many aspects of optimal treatment remain unknown, including ideal rTMS stimulation parameters, duration of treatment, and relationship to the underlying pain etiology. Here the investigators propose to evaluate the efficacy of high frequency rTMS to M1, the region with most evidence of benefit in chronic neuropathic pain, and to use functional magnetic resonance imaging (fMRI) to identify alternative rTMS targets for participants that do not respond to stimulation at M1. The central aim is to evaluate the pain relieving efficacy of multi-session high-frequency M1 TMS for pain. In secondary exploratory analyses, the investigator propose to investigate patient characteristic that are predictive of responsive to M1 rTMS and identify viable alternative stimulation targets in non-responders to M1 rTMS.
at UCSF
Intravenous (IV) Administration Of Elezanumab To Assess Change In Upper Extremity Motor Score (UEMS) In Adult Participants With Acute Traumatic Cervical Spinal Cord Injury (SCI)
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Sorry, in progress, not accepting new patients
Acute Spinal Cord Injury (SCI) is a rare injury that leads to permanent neuromotor impairment and sudden disability. Approximately 25,000 people experience cervical SCI in the United States, Europe, and Japan every year. The purpose of this study is to see if elezanumab is safe and assess change in Upper Extremity Motor Score (UEMS) in participants with acute traumatic cervical SCI. Elezanumab is an investigational drug being developed for the treatment of SCI. Elezanumab is a monoclonal antibody, that binds to an inhibitor of neuronal regeneration and neutralizes the inhibitor, thus potentially promoting neuroregeneration. This study is "double-blinded", which means that neither trial participants nor the study doctors will know who will be given which study drug. Study doctors put the participants in 1 of 2 groups, called treatment arms. Each group receives a different treatment. There is a 1 in 3 chance that participants will be assigned to placebo. Participants 18-75 years of age with a SCI will be enrolled. Approximately 54 participants will be enrolled in the study in approximately 49 sites worldwide. Participants will receive intravenous (IV) doses of elezanumab or placebo within 24 hours of injury and every 4 weeks thereafter through Week 48 for a total of 13 doses. There may be a higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the course of the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.
at UC Davis
Closed-loop Deep Brain Stimulation to Treat Refractory Neuropathic Pain
Sorry, in progress, not accepting new patients
Deep brain stimulation (DBS) holds promise as a new option for patients suffering from treatment-resistant chronic pain, but current technology is unable to reliably achieve long-term pain symptom relief. A "one-size-fits-all" approach of continuous, 24/7 brain stimulation has helped patients with some movement disorders, but the key to reducing pain may be the activation of stimulation only when needed, as this may help keep the brain from adapting to stimulation effects. By expanding the technological capabilities of an investigative brain stimulation device, the investigators will enable the delivery of stimulation only when pain signals in the brain are high, and then test whether this more personalized stimulation leads to reliable symptom relief for chronic pain patients over extended periods of time.
at UCSF
Decision Support Tool to Prevent Community-Acquired Pressure Injury in Spinal Cord Injury (SCI) in the Spinal Cord Injury Clinic
Sorry, not yet accepting patients
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.
at UCSD
Spinal Cord Neuromodulation for Spinal Cord Injury
Sorry, in progress, not accepting new patients
This study is designed to assess the strategy of using spinal cord stimulation to improve the ability to move in spinal cord injured humans.
at UCLA
MT-3921 in Subjects With Acute Traumatic Cervical Spinal Cord Injury
Sorry, in progress, not accepting new patients
The purpose of this study is to compare the efficacy and safety of intravenous (IV) infusions of MT-3921 to placebo in subjects with acute traumatic cervical spinal cord injury. Subjects meeting eligibility criteria will enter the 6-month double-blind period. Subjects will be randomized in a 2:1 ratio to receive MT-3921 or placebo in a double blind manner.
at UC Irvine
Telepsychology in Spinal Cord Injury
Sorry, in progress, not accepting new patients
This study will determine the effectiveness of tele-psychology in treating persons with spinal cord injury (SCI) with depressed mood in the early period post-rehabilitation discharge. Depression among individuals with SCI is the most common psychological condition following an injury; 22% of civilians with SCI and 28% of veterans with SCI experience depression after injury, which is higher than the able-bodied population (Williams 2015; Ullrich 2014). Individuals with SCI face many barriers in receiving psychotherapy, such as lack of accessible transportation, unfamiliarity with community resources, or stigma associated with seeking treatment for depression, which this project aims to address. Cognitive behavior therapy (CBT), which helps people develop different ways of thinking and behaving to reduce their psychological distress, will be provided via iPad FaceTime by a psychologist with expertise in working with persons with SCI. The objectives of the proposed project are to reduce depressive symptoms, decrease associated symptoms of anxiety, and to improve satisfaction with life with CBT provided via tele-psychology. The secondary objective is to show intermediate efficacy of tele-psychology in persons with SCI with depressed mood.
at UCSF
Incomplete Cervical SCI Without Instability
Sorry, not currently recruiting here
A multicenter, international, prospective, observational case series patient cohort with incomplete cervical SCI without instability will be enrolled to obtain information and data that could inform the feasibility of administering a set of additional core and optional outcome assessments in cervical SCI patients to capture the aspects of neurologic impairment. Baseline, intraoperative, and postoperative characteristics, including demographics, injury details, treatment details, neurological assessments, gait and balance assessments and upper extremity assessments, will be recorded for adult patients.
at UCSF
Transforming Research and Clinical Knowledge in Spinal Cord Injury
Sorry, accepting new patients by invitation only
The overall goal of Transforming Research and Clinical Knowledge in Spinal Cord Injury (TRACK-SCI) study is to determine the relationships among the clinical, neuroimaging, cognitive, genetic and proteomic biomarker characteristics of acute traumatic spinal cord injury (SCI). TRACK-SCI seeks to combine high quality care variables with high density physiology data collection to better understand diagnose, characterize, and track the temporal profile of recovery for SCI patients. The Investigators are enrolling patients within 24 hours of injury who present to a TRACK-SCI site with a spinal cord injury that meets eligibility criteria.
at UCSF
Our lead scientists for Spinal Cord Injury research studies include Karunesh Ganguly, MD, PhD Sergey Stavisky, Ph.D. Michael Su, MD David M Brandman, MD, PhD Julian C Motzkin, MD/PhD Anthony Digiorgio Prasad Shirvalkar Edward Chang, M.D. Michael S Beattie, PhD Daniel Lu, MD, PhD.
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