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Spinal Cord Injuries clinical trials

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NCT ID: NCT02564419 Completed - Spinal Cord Injury Clinical Trials

Brain Machine Interface (BMI) in Subjects Living With Quadriplegia

BMI
Start date: November 2015
Phase: N/A
Study type: Interventional

In this study, investigators will show proof-of-concept that brain signals can be used in real-time, closed-loop mode to trigger stimulation for hand function. Subjects will undergo surgery to implant a unilateral subdural strip electrode (Resume II, Model 3587A) over the motor cortex. These electrodes implanted in the brain will enable bioelectrical data recording (sensing) from the brain to the implanted Activa PC+S. The cortical sensing data will be 1. either processed in the Activa PC+S; or 2. off-loaded via the Nexus D communication device (Medtronic) to a computer.

NCT ID: NCT02562001 Completed - Clinical trials for Spinal Cord Injuries

Association Between tDCS and Lokomat Training in Patients With Incomplete Spinal Cord Injury

Start date: May 6, 2015
Phase: N/A
Study type: Interventional

The spinal cord injury is identified as the major cause of permanent disability worldwide, with the loss of ability to walk being the largest and most devastating of them for these patients. Our goal is to analyze the effects of electrical transcranial direct-current stimulation (tDCS) combined with gait training with partial body weight support aided by robotic device (Lokomat, Hocoma) in the gait of patients with incomplete spinal cord injury (SCI). In this stratified randomized double-blind study, the participants will be randomly allocated into one of both groups, outpatients (GA) or inpatients (GI), and will receive active or placebo tDCS followed by gait training with Lokomat (GA: 3 sessions/week x 10 weeks = 30 sessions; GI: 5 sessions/week x 6 weeks = 30 sessions). The functional assessments (through clinical and functional scales, assess gait, muscle strength, spasticity, balance and pain) and neurophysiological (cortical excitability measured by transcranial magnetic stimulation, electroencephalography and functional near-infrared spectroscopy) will be held before and after the training period. The functional assessments will be also held after 15 sessions (intermediate) and after 3 months follow up. The expected result is that patients that received the active tDCS presents an improvement over the ground gait after the Lokomat training period significantly greater than the placebo group, with relations between neurophysiologic, kinematics and functional measurements.

NCT ID: NCT02561676 Completed - Chronic Pain Clinical Trials

Improving Functioning in Persons With Chronic Pain Post-SCI Through Virtual Classroom Education

Start date: March 2015
Phase: Phase 1/Phase 2
Study type: Interventional

Chronic pain (pain that is that is present for a long period of time) is very common among people with spinal cord injury (SCI). The purpose of this study is to compare how well two different web-based education programs reduce the level to which chronic pain interferes with daily activities and well-being.

NCT ID: NCT02560506 Completed - Spinal Cord Injury Clinical Trials

Development of Low Cost Devices to Increase Access to Treadmill Training

Start date: January 2008
Phase: N/A
Study type: Interventional

The goals of this Model System Program are to expand upon and advance the findings and outcomes of previous and current Model Systems clinical research, to continue to develop and study the effectiveness of innovative treatment strategies for persons with spinal cord injury (SCI); and to evaluate the benefits of a well-designed, comprehensive, coordinated, interdisciplinary continuum of care that lead to improved outcomes for all persons with SCI. In order to achieve these goals, the following objectives of the Midwest Regional Spinal Cord Injury Care System (MRSCICS) model system grant proposal will be accomplished.

NCT ID: NCT02556125 Completed - Clinical trials for Injuries, Spinal Cord

Diaphragm Pacing After Spinal Cord Injury

Start date: December 2015
Phase:
Study type: Observational

Respiratory dysfunction is the leading cause of death in individuals with spinal cord injuries (SCIs). Nearly one quarter of all SCI cases involve injury to the upper spinal cord segments which impairs neural activation of the diaphragm muscle and compromises breathing. Although mechanical ventilation can be life-saving after cervical SCI (C-SCI), it also triggers rapid and profound diaphragm muscle atrophy, thereby complicating (or even preventing) ventilator weaning. Intramuscular diaphragm stimulation, or diaphragm pacing, was developed to replace long-term ventilator support, and is now used acutely post C-SCI (<4 months following injury) to promote ventilator weaning. The impact of diaphragm pacing on respiratory function and diaphragm muscle activation has not been formally evaluated. This is an essential step in determining the efficacy of intramuscular diaphragm stimulation and its effects on respiratory function after SCI. Accordingly, this research study will evaluate the effects of intramuscular diaphragm stimulation and test the hypothesis that diaphragm pacing enhances neuromuscular diaphragm activation and respiratory function in adults with cervical SCIs. The investigators will test the hypothesis by evaluating the effects of diaphragm pacing on neuromuscular activation of the diaphragm by directly recording electromyogram (EMG) activity from the intramuscular pacing electrodes. Recording from these surgically-implanted electrodes allows direct comparisons of EMG activity across time, minimizing methodological limitations inherent with surface or percutaneous EMG recordings. This approach, in association with respiratory assessments, will be used to investigate the impact of diaphragm pacing in adults with intramuscular diaphragm pacing electrodes following acute, traumatic C-SCIs.

NCT ID: NCT02554201 Completed - Clinical trials for Spinal Cord Injuries

Efficacy of Electrical Pudendal Nerve Stimulation for Neurogenic Lower Urinary Tract Dysfunction

Start date: October 2015
Phase: N/A
Study type: Interventional

The main goal to treat early NLUTS is to relieve lower urinary tract syndrome and prevent from late complications. The present study is to evaluate the efficacy of electrical pudendal nerve stimulation (EPNS) and transanal/transvaginal electrical stimulation (TES) in NLUTD.The study design consists of a non-randomized, parallel controlled trial. A total of 60 eligible patients will be involved and divided into EPNS or TES group according to their location of medical treatment. The primary endpoint is lower urinary tract syndromes (ICIQ-FLUTS/MLUTS). The second endpoint is assessment of daily life Qol (ICIQ-LUTSqol), and residual urine volume.

NCT ID: NCT02554058 Completed - Spinal Cord Injury Clinical Trials

Combined Tactile and Proprioception Training After Spinal Cord Injury

Start date: May 2015
Phase: N/A
Study type: Interventional

A novel rehabilitation bike has been developed for patients with incomplete spinal cord injuries that incorporates mechanical stimulators on the bike pedals to stimulate the sensory receptors in the soles of the feet; the effect of mechanical stimulator on muscle strengthening has been reported by NASA to improve muscle atrophy in astronauts in zero-gravity environments. Cycling also stimulates lower limb position sensors. We predict that the combination of mechanical stimulation with cycling may be similar enough to walking over ground to lead to gains in balance and mobility. The present study will evaluate the therapeutic effect of this bike on balance, walking, as well as cortical-spinal and spinal pathways in patients with incomplete spinal cord injuries.

NCT ID: NCT02550834 Completed - Spinal Cord Injury Clinical Trials

Wheelchair Indoors Curling With SCI patients_RCT

SCI-RCT
Start date: August 2015
Phase: Phase 1/Phase 2
Study type: Interventional

This study investigates if, patients with diagnosed chronic spinal cord injury will benefit from an Indoor Curling Exercise program on their control capabilities of trunk movements and on their intrinsic motivation for physical activity. Half of participants will receive 8 training-sessions during 4 weeks, while the other will receive usual care.

NCT ID: NCT02537899 Completed - Spinal Cord Injury Clinical Trials

Spinal Cord Injury - Assessing Tolerability and Use of Combined Rehabilitation and NeuroAiD

SATURN
Start date: April 2015
Phase: Phase 4
Study type: Interventional

SATURN investigates the promising role of NeuroAiD in patients with spinal cord injury and will provide important information on the feasibility of conducting larger controlled trials.

NCT ID: NCT02522507 Completed - Cerebral Palsy Clinical Trials

A Peer E-mentoring Intervention to Improve Employment

Start date: January 2016
Phase: N/A
Study type: Interventional

Despite the strong business case of hiring people with disabilities, a significant proportion of youth with disabilities leave high school and neither work nor continue their education and are unprepared to meet the demands of a work environment. Although youth with disabilities have much to gain from employment readiness programs, they are often excluded from, or have limited access to school and community vocational programs. One encouraging approach to address gaps in vocational programming is through peer mentoring, which may facilitate a smoother transition to adulthood by offering support to enhance coping skills. Despite the increase in online communities, little is known about their impact on vocational mentoring for youth with physical disabilities and their parents. The purpose of this study is to develop, implement and assess the feasibility of an online peer mentor employment readiness intervention for youth with physical disabilities and their parents to improve their self-efficacy, career maturity and social support.