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Spinal Cord Injury clinical trials

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NCT ID: NCT03621254 Recruiting - Spinal Cord Injury Clinical Trials

Investigation Into Optimal FES Training Characteristics After Spinal Cord Injury

Start date: January 7, 2019
Phase: N/A
Study type: Interventional

The aim of this study is to investigate two different modalities of functional electrical stimulation (FES) leg exercise in patients with spinal cord injury (SCI). The primary outcomes being compared are 1. FES-induced leg aerobic fitness, and 2. FES-induced leg strength. There will be two FES-leg training groups, and sub-acute patients with SCI will be randomised between the groups - high-short [HI-SHORT] and low-long [LO-LONG]. Both groups (n=10 per group) will exercise on the Hasomed RehaStimâ„¢ exercise ergometer for 6-8 weeks, three-four times per week (24 therapy sessions). [HI-SHORT] will perform 10 x 2-min of high-intensity interval training with a recovery of 1-2 min between exercise bouts. [LO-LONG] will perform 20+ min of continuous exercise at a low-moderate exercise intensity. Exercise intensity for [HI-SHORT] and [LO-LONG] will be titrated by neuromuscular stimulation characteristics. The primary outcomes will be assessed before training commences and after 6-8 weeks of training has been completed.

NCT ID: NCT03521336 Recruiting - Spinal Cord Injury Clinical Trials

Intrathecal Transplantation of UC-MSC in Patients With Sub-Acute Spinal Cord Injury

Start date: September 1, 2019
Phase: Phase 2
Study type: Interventional

This study aim to evaluate the safety and efficacy of intrathecal transplantation of allogeneic umbilical cord derived mesenchymal stem cells (UC-MSC) for treatment of different phrases of spinal cord injury. Here, the history of spinal cord injury is divided into three periods, Sub-acute SCI, Early stage of chronic SCI, and Late stage of chronic SCI, which is 2W-2M, 2M-12M, and more than 12M after injury, respectively. The purpose is to investigate whether the patients with spinal cord injury benefit from UC-MSC transplantation, and then find out the best time for SCI treatment. In this part of the study, the investigators will treat patients with sub-acute spinal cord injury with UC-MSC transplantation or placebo.

NCT ID: NCT03447509 Recruiting - Spinal Cord Injury Clinical Trials

Grasping Function After Spinal Cord Injury

Start date: March 17, 2020
Phase: N/A
Study type: Interventional

The overall goals of this proposal are to examine the contribution of physiological pathways to the control of grasping behaviors after cervical SCI, and to maximize the recovery of grasping by using tailored non-invasive brain stimulation and acoustic startle protocols with motor training. The investigators propose to study two basic grasping behaviors, which are largely used in most daily-life activities: a precision grip and a power grip.

NCT ID: NCT03096197 Recruiting - Spinal Cord Injury Clinical Trials

Exoskeleton and Spinal Cord Stimulation for SCI

Start date: March 30, 2017
Phase: N/A
Study type: Interventional

The overall aim of this project is to assess the effect of combining transcutaneous lumbosacral stimulation (TLS) during Exoskeleton Assisted Walking (EAW) compared to EAW alone without stimulation on walking recovery.

NCT ID: NCT03053791 Recruiting - Spinal Cord Injury Clinical Trials

Deep Brain Stimulation in Patients With Incomplete Spinal Cord Injury for Improvement of Gait

DBS-SCI
Start date: March 15, 2018
Phase: N/A
Study type: Interventional

Spinal cord injuries are anatomically mostly incomplete, showing tissue bridges of the spinal cord at the injury site. Of the 60% functionally incomplete patients, about half face a life in the wheelchair. Besides conventional rehabilitation, no prominsing further treatment options exist. One of the most plastic systems involved in locomotion is the pontomedullary reticulospinal tract, which is the oldest locomotor command system existing in most vertebrates, including primates. Muscle activation patterns for limb movements are programmed in the spinal cord and have to be activated and coordinated through commands from the so called mesencephalic locomotor region (MLR). The MLR consists of nerve cells in the lower mesencephalic tegmentum sending uni- and bilateral signals through the medullary reticulospinal tracts. Classical physiological studies showed that electrical stimulation of the MLR induce locomotion. For the first time this approach was transferred and recently published in a model of induced incomplete spinal cord injury by the Schwab group. Rats severly impaired in motor hindlimb control with only 10-20% spared white matter, recovered with fully functional weight bearing locomotion under MLR deep brain stimulation (DBS). Even rats with only 2-10% spared white matter regained weight supporting stepping. DBS is a clinical standard treatment option in patients with movement disorders but does not relieve all symptoms. Therefore, small studies of MLR stimulations have been safely used in Parkinsonian patients showing freezing of gait and frequent falls with variable results. In a translational approach, we aim at performing a multidisciplinary phase one clinical trial with 5 patients and incomplete spinal cord injury. With the means of our established universitary setup for DBS treatments the operations will be performed unilaterally under local anaesthesia in the Division of Neurosurgery, USZ, with perioperative electrophysiological recordings, clinical assessments and gait analysis under test stimulation in the Spinal Cord Injury Center Balgrist.

NCT ID: NCT02991248 Recruiting - Spinal Cord Injury Clinical Trials

Improve Dynamic Lateral Balance of Humans With SCI

Start date: November 1, 2018
Phase: N/A
Study type: Interventional

This study is to test whether pelvis perturbation training paired with transcutaneous spinal direct current stimulation (tsDCS) will be effective in improving dynamic balance and locomotor function in humans with SCI. One group will receive pelvis perturbation training paired with tsDCS, one group will receive pelvis perturbation training paired with sham, and one group will receive treadmill training only.

NCT ID: NCT02978638 Recruiting - Spinal Cord Injury Clinical Trials

Electrical Stimulation for Continence After Spinal Cord Injury

Start date: September 2014
Phase: N/A
Study type: Interventional

This study aims to improve continence and voiding of patients with spinal cord injury using electrical stimulation. The Finetech Vocare Bladder System is an implantable sacral nerve stimulator for improving bladder and bowel function in patients with spinal cord injury (SCI). It has been commercially available in Britain and other countries since 1982, and has been used in thousands of patients with SCI to improve bladder, bowel and sexual function. It received FDA approval in 1998 under Humanitarian Device Exemption H980005 and H980008 for providing urination on demand and to aid in bowel evacuation. Electrical stimulation to produce bladder contraction and improve bladder voiding after spinal cord injury has usually been combined with cutting of sensory nerves to reduce reflex contraction of the bladder, which improves continence. However, cutting these nerves has undesirable side effects. This study will not cut any sensory nerve. This study is testing the use of the stimulator for inhibiting bladder contraction by stimulating sensory nerves to improve continence after spinal cord injury, and for blocking sphincter contraction to improve voiding.

NCT ID: NCT02938130 Recruiting - Cerebral Palsy Clinical Trials

The Impact of Community-based Wellness Programs on The Triple Aim

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

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.

NCT ID: NCT02922894 Recruiting - Spinal Cord Injury Clinical Trials

Treatment of Sleep Apnea in Patients With Cervical Spinal Cord Injury

Start date: June 9, 2017
Phase: Phase 4
Study type: Interventional

This study will investigate potential therapeutic approaches for sleep-disordered breathing (SDB) in patients with chronic cervical spine injury (>6 months post-injury).

NCT ID: NCT02870426 Recruiting - Spinal Cord Injury Clinical Trials

Collection and Characterisation of Human Olfactory Ensheathing Cells

Start date: April 9, 2018
Phase:
Study type: Observational

We aim to retrieve olfactory bulbs (OBs) from suitable human donors. We have defined two groups who will qualify: Group 1 - Deceased Donors: 1A: Donors after brainstem death (DBDs) undergoing solid organ donation 1B: Donors after brainstem death (DBDs) considered unsuitable for solid organ donation Group 2 - Living Donors: Neurosurgical patients undergoing anterior cranial surgery in which the olfactory nerve (ON) is cut as part of the surgical procedure. The OB of the concomitant severed ON would be donated. We aim to optimise OB collection and Olfactory Ensheathing Cell (OEC) culture and storage. We will study the effects of patient diagnosis, age, cause of death (if applicable), co-morbidities and warm ischaemic time on cell survival and regenerative function. In future studies we aim to store OECs in a GMP facility and transplant OECs into patients with spinal cord injuries.