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Spinal Cord Injuries clinical trials

View clinical trials related to Spinal Cord Injuries.

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NCT ID: NCT05744271 Recruiting - Stroke Clinical Trials

Evaluation of FES+VFBT With Individuals With Lived Experience

Start date: April 1, 2023
Phase: N/A
Study type: Interventional

Falls are an "emerging public health crisis" that cost the Canadian health care system billions of dollars each year. Moreover falls have a significant, detrimental impact on the lives of those who fall. In addition to physical injury and hospital admission, individuals may experience a post-fall syndrome characterized by dependence, depression, and reduced mobility and participation. Individuals living with the effects of neurological disease or injury are at a particularly high risk of falling. For example, 69-78% of individuals with spinal cord injury or disease (SCI/D) and 73% of individuals post-stroke fall at least once per year. Despite this high fall risk, evidence-based initiatives to prevent falls among those with SCI/D or stroke are lacking in neurorehabilitation. Furthermore, little time is dedicated to improving balance during inpatient neurorehabilitation. For example, ambulatory inpatients with SCI/D spend, on average, a mere 2.0±2.0 hours on balance training over the course of their entire inpatient stay. Our team is developing effective solutions to the "high-volume, high-risk and high-cost challenge" of falls. Our long-term objective is to develop an intervention that improves balance in a clinically meaningful and feasible way, facilitating the recovery of safe upright mobility and addressing the current health crisis of falls in individuals living with neurological disease or injury. The intervention will be developed with a focus on neurological populations, as these patient groups have a critical need for balance training; however, the intervention will be transferrable to other populations at risk of falls, such as older able-bodied adults. A probable solution to the gap in balance interventions is functional electrical stimulation (FES), whereby an electrical current is applied to peripheral nerves to facilitate muscle contractions. By applying the appropriate amount of electrical stimulation at the appropriate time during movement execution, the central nervous system can be re-educated, facilitating motor and functional improvements. The investigators developed a closed-loop FES system whose controller mimics the physiological control system. By combining this system with visual feedback balance training (VFBT), the investigators developed a prototype system of FES and VFBT (FES+VFBT). This intervention involves standing on a force plate with one's centre of pressure (COP) presented on a monitor. As the user moves his/her COP in response to a game, FES is delivered to the plantarflexor and dorsiflexor muscles through the device, MyndSearch.

NCT ID: NCT05741788 Recruiting - Chronic Pain Clinical Trials

The Teaspoon Study - Telefitting Spinal Cord Stimulation for Pain

Start date: October 1, 2023
Phase: N/A
Study type: Interventional

Spinal cord stimulation modulates the nervous system to effectively block pain signals originating from the back and legs. Spinal cord stimulation has been shown to improve chronic pain, improve quality of life, and reduce disability. Unfortunately, spinal cord stimulation has a high trial failure rate and a high long-term failure rate. This study consists of a prospective cohort of patients clinically scheduled to undergo spinal cord stimulation for the treatment of chronic back pain or radiculopathy. Participants will undergo a structured optimization evaluating existing types of stimulation (tonic, burst, and multistim). Each participant will try out all types of available stimulation but be blinded to the type. Over the course of four months, each participant will evaluate each type of stimulation by reporting daily pain scores. Thompson sampling will be used to identify which setting produces the biggest improvement in pain and recommend it for future use. Participants will follow up routinely to collect laboratory, behavioral, and survey responses to test for the feasibility of obtaining data explaining pain phenotype.

NCT ID: NCT05739734 Not yet recruiting - Clinical trials for Thoracic Spinal Cord Injury

Safety of CRIS100 on Treatment Spinal Cord Injury

Start date: May 15, 2023
Phase: Early Phase 1
Study type: Interventional

The goal of this clinical trial is to test CRIS100 treatment in participants with acute thoracic spinal cord injury. The main questions it aims to answer are: - safety of CRIS100 - efficacy of CRIS100 Participants will receive 75 mcg CRIS100 in the epicenter of the spinal injury, within 72 hours of the trauma.

NCT ID: NCT05731986 Recruiting - Clinical trials for Cardiovascular Diseases

Spinal Cord Transcutaneous Stimulation Effect on Blood Pressure in Acute Spinal Cord Injury (SCI)

SCI
Start date: June 2023
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to evaluate the effect of transcutaneous spinal cord stimulation on blood pressure in individuals with an acute spinal cord injury (within 30 days of injury). Blood pressure instability, specifically orthostatic hypotension (a drop in blood pressure when moving lying flat on your back to an upright position), appears early after the injury and often significantly interferes with participation in the critical rehabilitation time period. The main questions it aims to answer are: 1. Can optimal spinal stimulation increase blood pressure and resolve orthostatic symptoms (such as dizziness and nausea) when individuals undergo an orthostatic provocation (a sit-up test)? Optimal stimulation and sham stimulation (which is similar to a placebo treatment) will be compared. 2. What are the various spinal sites and stimulation parameters that can be used to increase and stabilize blood pressure to the normal range of 110-120 mmHg? Participants will undergo orthostatic tests (lying on a bed that starts out flat and then moved into an upright seated position by raising the head of bed by 90° and dropping the base of the bed by 90° from the knee) with optimal and sham stimulation, and their blood pressure measurements will be evaluated and compared.

NCT ID: NCT05730049 Recruiting - Inflammation Clinical Trials

Neuromodulation as an Anti-inflammatory Treatment in SCI

Start date: January 1, 2024
Phase: N/A
Study type: Interventional

The goal of this single-blinded randomized, controlled trial is to assess the impact of 1-hour of active transcutaneous auricular vagus nerve stimulation (taVNS) vs sham taVNS on serum biomarkers of the inflammatory reflex and inflammation in individuals with spinal cord injury. The main question it aims to answer is: whether taVNS is a safe and effective anti-inflammatory intervention for individuals with SCI. Participants will perform a single 1-hour bout of the respective taVNS treatment with blood draws prior to treatment, immediately following treatment, and 24 hours following treatment. Changes in biomarkers between the active and sham taVNS conditions will be compared.

NCT ID: NCT05726773 Completed - Tetraplegia Clinical Trials

The Effect of Robot Assisted Hand Therapy in Patients With Spinal Cord Injury

Start date: December 15, 2021
Phase: N/A
Study type: Interventional

Considering the scarcity of studies on robotic hand therapy, it has been seen that larger-scale and long-term follow-up studies are needed. In this study, our aim is to compare the effects of robot-assisted hand therapy and conventional physiotherapy on hand functions and quality of life in patients with spinal cord injury.

NCT ID: NCT05726591 Recruiting - Cerebral Palsy Clinical Trials

Evaluating Long-term Use of a Pediatric Robotic Exoskeleton (P.REX/Agilik) to Improve Gait in Children With Movement Disorders

Start date: May 2, 2023
Phase: N/A
Study type: Interventional

Background: People with cerebral palsy, spina bifida, muscular dystrophy, or spinal cord injury often have muscle weakness and problems controlling how their legs move. This can affect how they walk. The NIH has designed a robotic device (exoskeleton) that can be worn on the legs while walking. The wearable robot offers a new form of gait training. Objective: To learn whether a robotic device worn on the legs can improve walking ability in those with a gait disorder. Eligibility: People aged 3 to 17 years with a gait disorder involving the knee joint. Design: Participants will be screened. They will have a physical exam. Their walking ability will be tested. Participants will have markers taped on their body; they will walk while cameras record their movements. They will undergo other tests of their motor function and muscle strength. The study will be split into three 12-week phases. During 1 phase, participants will continue with their standard therapy. During another phase, participants will work with the exoskeleton in a lab setting. Their legs will be scanned to create an exoskeleton with a customized fit. The exoskeleton operates in different modes: in exercise mode, it applies force that makes it difficult to take steps; in assistance mode, it applies force meant to aid walking; in combination mode, it alternates between these two approaches. During the third phase, participants may take the exoskeleton home. They will walk in the device at least 1 hour per day, 5 days per week, for 12 weeks. Participants walking ability will be retested after each phase....

NCT ID: NCT05725499 Recruiting - Clinical trials for Cardiovascular Diseases

The Effect of Transcutaneous Stimulation on Blood Pressure in Spinal Cord Injury (SCI)

SCI
Start date: May 1, 2023
Phase: N/A
Study type: Interventional

This project will investigate the effect of spinal cord transcutaneous stimulation on blood pressure in individuals with a chronic spinal cord injury who experience blood pressure instability, specifically, orthostatic hypotension (a drop in blood pressure when moving from lying flat on your back to an upright position). The main questions it aims to answer are: 1. What are the various spinal sites and stimulation parameters that normalize and stabilize blood pressure during an orthostatic provocation (70 degrees tilt)? 2. Does training, i.e., exposure to repeated stimulation sessions, have an effect on blood pressure stability? Participants will undergo orthostatic tests (lying on a table that starts out flat, then tilts upward up to 70 degrees), with and without stimulation, and changes in their blood pressure will be evaluated.

NCT ID: NCT05725161 Recruiting - Depression Clinical Trials

Acceptance and Commitment Therapy for Depressed Individuals Living With Spinal Cord Injury Sustained Within 5 Years

Start date: March 8, 2023
Phase: N/A
Study type: Interventional

This randomized controlled trial aims to assess effects of videoconferencing acceptance and commitment therapy (ACT) on mental health outcomes in individuals living with spinal cord injuries (SCI). A total of 40 individuals living with SCI sustained within 5 years and experiencing depressive symptoms will be recruited and randomly assigned to either the ACT group or the wait-list control group. The ACT group will receive 8 weekly individual ACT sessions guided by a coach through videoconferencing. The wait-list group will receive ACT sessions after the study period ends. We will provide psychoeducation materials related to SCI as supplemental resources to both groups. Mental health outcomes using self-reported questionnaires will be collected at pretest, posttest, and 2-month follow-up. Exploratory hypotheses are that the group undergoing the ACT intervention supplemented with psychoeducation will show improvements in mental health outcomes (e.g., depression) and ACT processes (e.g., psychological flexibility) at posttest and 2-month follow-up, compared to the wait-list control group provided with psychoeducation materials alone. Interviews will be conducted at posttest to explore the participants' experiences in ACT.

NCT ID: NCT05724173 Recruiting - Clinical trials for Spinal Cord Injuries

Feasibility of the BrainGate2 Neural Interface System in Persons With Tetraplegia

BG-Speech-01
Start date: October 18, 2023
Phase: N/A
Study type: Interventional

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.