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Spinal Cord Injuries clinical trials

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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: NCT03048331 Recruiting - Clinical trials for Spinal Cord Injury Cervical

Functional Electrical Stimulation (FES) and Reconstructive Tetraplegia Hand and Arm Surgery

FES
Start date: March 1, 2017
Phase: N/A
Study type: Interventional

FES is a common and established method in the rehabilitation of persons with spinal cord injury (SCI). Some known effects of FES were investigated in several studies e.g. avoiding disuse and denervation atrophy, improving muscle force, power output and endurance changing muscle fibre type, increasing cross sectional area of muscle, increasing muscle mass, activation of nerve sprouting, reducing spasticity and motor learning. Most of the studies investigated the impact of FES in the lower limbs. For the upper extremities fewer studies exist. However, it is supposed that the effects of FES are similar. In the rehabilitation of persons with tetraplegia, FES, especially the stimulation of the upper extremities triggered by electromyography (EMG) is an established method to generally improve hand and arm function. However, none of those studies has investigated the effect of FES in combination with reconstructive tetraplegia hand surgery. Improved muscle strength is supposed to improve the functional outcome in participation. Additionally, FES could increase the motor learning process. Supported by the clinical observation we hypothesize that FES has a positive influence on the outcome of surgical reconstruction of tendon and/or nerve transfers.

NCT ID: NCT03031223 Recruiting - Clinical trials for Spinal Cord Injuries

Evaluation of Sensory-motor Response to Low-level Laser Therapy for the Treatment of Spinal Injuries

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

Spinal cord injuries have become increasingly frequent due mainly to the increase in urban violence. The growing number of automobile collisions and violence-related events merits particular attention, as such occurrences can lead to death or disability stemming from a spinal injury. The severity of the consequences depends on the location affected and degree of destruction of afferent and efferent spinal cord pathways, with higher, more extensive injuries leading to less physical fitness and functional independence. Unfortunately, injured neurons of the central nervous system are unable to regenerate following a spinal injury and spinal cord regeneration is therefore a major challenge to researchers in the fields of neuroscience and neurologia. Upon receiving an external stimulus, the central nervous system is believed to adapt and reorganize itself using mechanisms to compensate for neuronal loss and promote, even if partially, the remodeling of remaining synaptic connections, leading to new neuronal sprouting. Low-level laser therapy (LLLT) has proven to be a possible option for the stimulation of the repair process in the central nervous system. It is plausible that this type of therapy can offer the same benefits previously established in other types of tissues, the stimulation of bone formation, neovascularization and the regeneration of peripheral nerves. Research groups have investigated the efficacy of LLLT for the treatment of spinal cord injuries and have demonstrated that laser therapy administered simultaneously to an injured sciatic nerve and corresponding segment of the spinal cord accelerates the regeneration process of the injured peripheral nerve.

NCT ID: NCT03026816 Recruiting - Clinical trials for Spinal Cord Injuries

Epidural Stimulation After Neurologic Damage

E-STAND
Start date: August 7, 2017
Phase: N/A
Study type: Interventional

This study will evaluate a method to optimize parameter settings in epidural spinal cord stimulation used to recover lower extremity volitional movement. The study will also characterize improvement in autonomic function (such as blood pressure control) and other functions related to spinal cord injury.

NCT ID: NCT02991690 Recruiting - Clinical trials for Spinal Cord Injury, Acute

Systemic Hypothermia in Acute Cervical Spinal Cord Injury

Start date: August 4, 2017
Phase: N/A
Study type: Interventional

This study is a prospective multi-center trial designed to determine the safety profile and efficacy of modest (33ºC) intravascular hypothermia following acute cervical (C1 to C8) Spinal Cord Injury (SCI).

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: NCT02983955 Recruiting - Clinical trials for Spinal Cord Injury Cervical

UPNRIDE Powered Wheelchair for Individuals With Walking Impairment: Evaluation of Safety and Usability

UPNRIDE_SAFE
Start date: November 2016
Phase: N/A
Study type: Interventional

The UPnRIDE Powered Wheelchair device is a product which changes people position from sitting to standing and standing to sitting. The product provides indoor and outdoor mobility. The main purpose of this study is to evaluate the safety of the UPnRIDE powered wheelchair as an outdoor and indoor mobility device by individuals with walking impairment.

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: NCT02944669 Recruiting - Clinical trials for Injuries, Spinal Cord

ReWalk Personal Device Postmarket Study

Start date: June 2016
Phase: N/A
Study type: Observational

This study seeks to further evaluate the Multi-Tiered Training Program and to further explore the overall safety profile of the ReWalk Personal Device outside of the institutional setting under conditions of routine medical practice.

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.