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Spinal Cord Injuries clinical trials

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NCT ID: NCT04054414 Recruiting - Clinical trials for Acute Spinal Cord Injury

PMZ-1620 (Sovateltide) in Patients of Acute Spinal Cord Injury

Start date: January 10, 2019
Phase: Phase 2
Study type: Interventional

This was a prospective, multicentric, randomized, double blind, parallel, saline controlled Phase II clinical study to compare the safety and efficacy of PMZ-1620 (INN: Sovateltide) therapy along with standard supportive care in patients of acute spinal cord injury.

NCT ID: NCT04052009 Recruiting - Clinical trials for Incomplete Spinal Cord Injury

Locomotor Training in Individuals With Incomplete Spinal Cord Injury. A Pilot Study

Start date: September 24, 2019
Phase: N/A
Study type: Interventional

Background: In Switzerland, about 6000 individuals live with the consequences of a spinal cord injury (Brinkhof et al, 2016). One of the major goals after an incomplete spinal cord injury (iSCI) is to regain walking function. To this end, different approaches are used in rehabilitation such as treadmill-based, robotic-assisted (exoskeleton or end-effector) and conventional gait training. According to current literature, the superiority of one of these approaches remains unclear (Mehrholz, Harvey, Thomas, and Elsner, 2017); In the research on gait rehabilitation after iSCI, recent randomized clinical trials (RCTs) found no statistical differences between conventional gait training and robotic-assisted gait training. Nevertheless, according to the comparison of effect sizes obtained from these training, these trials suggested that the conventional training approach leads to larger improvements in gait capacity when compared to robotic-assisted therapy (Field-Fote and Roach, 2011; Nooijen, Ter Hoeve, and Field-Fote, 2009). Therefore, these trials highly recommended further research considering these aspects. However, in clinical settings, the implementation of such systematic and intense training sessions remains challenging. The present study aims to test the hypothesis that conventional training might have larger effect sizes on gait capacity and to evaluate the feasibility of such systematic training in a clinical setting of inpatient rehabilitation. Objectives: To contribute to the current knowledge on best clinical practice in gait rehabilitation within the iSCI population. More specifically, the study objectives are two-fold: A first objective is to compare the effects of conventional training, end-effector based therapy and the combination of these interventions on the gait ability of iSCI. A second objective is the evaluation of the feasibility of systematic gait training protocols in a clinical setting. Participants: Individuals with motor incomplete spinal cord injury (iSCI), presenting a traumatic or non-traumatic iSCI with an injury onset <6 months. Intervention: Participants will be trained in one of the three groups by trained physical therapists during 10 sessions, 3x/week with an average duration of 30 minutes. Outcomes: To attain the first objective the effects will be quantified by the following main outcomes: Walking capacity (independence), walking speed, and safety. Feasibility of the systematic intervention will be evaluated using the drop-outs of therapy interventions.

NCT ID: NCT04050696 Recruiting - Clinical trials for Incomplete Spinal Cord Injury

The Use of Electromagnetic Field (EMF) Treatment in Chronic Spinal Cord Injury (SCI) Patients

Start date: September 18, 2019
Phase: N/A
Study type: Interventional

The purpose of this study is to further establish safety and efficacy of the BQ EMF treatment of chronic SCI subjects who demonstrate stability in The Graded and Redefined Assessment of Strength, Sensibility and Prehension (GRASSP) strength score following a one-month physical therapy run-in period.

NCT ID: NCT04047992 Recruiting - Clinical trials for Spinal Cord Injuries

Seated Balance Using the Indego™

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

Exoskeleton-assisted walking (EAW) provides a new mobility option and appears to have potential therapeutic benefits for persons with SCI. However, present day technology is not sufficient to replace the wheelchair. During EAW, users stand upright, maintain static and dynamic balance by actively and passively stimulating trunk and lower limb muscles in a manner not challenged during wheelchair use. Preliminary results in our laboratory suggest that the indirect balance challenges and postural perturbations that result during EAW training transfer to better seated balance control, resulting in more independence during seated activities. The purpose of this pilot study is to determine the effects of EAW training on various measures of seated balance (primary outcomes) and body composition (secondary outcomes). Twenty people with SCI (T4 and below) who are wheelchair users for mobility and cannot walk independently will be recruited. The participants will receive 36 sessions of EAW training in 12 weeks. The outcomes will be evaluated pre (baseline) and post (24 and 36 sessions). If EAW devices can be demonstrated to help people with SCI have better seated balance, in addition to the other potential benefits that are being investigated elsewhere, then exoskeletons may have the possibility to be more readily accepted in the clinical, home environments, and by the insurance companies.

NCT ID: NCT04041063 Recruiting - Clinical trials for Spinal Cord Injuries

Rehabilitation and Cortical Remodeling After Surgical Intervention for Spinal Cord Injury

Start date: July 26, 2019
Phase: Phase 2
Study type: Interventional

The aim of this study is to determine the effects of rehabilitation on dexterous hand movements and cortical motor map changes in tetraplegic patients following nerve transfer surgery. The working hypothesis is that robot-assisted, intensive rehabilitation will support the return of hand and arm function and strengthen the cortical representations of targeted muscles. The investigators will assess this through TMS mapping and clinical measures of hand and arm function.

NCT ID: NCT04032990 Recruiting - Clinical trials for Spinal Cord Injuries

Transcutaneous Spinal Stimulation: Safety and Feasibility for Upper Limb Function in Children With Spinal Cord Injury

Start date: November 14, 2019
Phase: N/A
Study type: Interventional

Children who suffer a spinal cord injury in the neck region have difficulty using their hands due to paralysis and/or weakness of their arms and hand muscles. The purpose of this project is to test the safety, comfort, and practicality of a new therapy that stimulates the spinal cord to facilitate activation of arm and hand muscles while practicing grasping, pinching, and reaching movements. The long-term goal is to provide better therapies that will improve the ability of children with SCI to more successfully play and accomplish everyday tasks using their arms and hands, similar to before their injury.

NCT ID: NCT04029974 Recruiting - Clinical trials for Spinal Cord Injuries

Speed of Robotic Leg Movements and Orthostatic Hypotension in Subacute SCI

Start date: August 20, 2019
Phase: N/A
Study type: Interventional

This study seeks to evaluate whether the speed (cadence) of lower extremity robotic movement has an impact on orthostatic hypotension and upright tolerance when training with the ErigoPro robotic tilt-stepper. It is hypothesized more frequent short-lasting leg movements (faster cadence) reduces the occurrence/severity of orthostatic hypotension better than less frequent longer-lasting leg movements (slower cadence).

NCT ID: NCT04023591 Recruiting - Clinical trials for Spinal Cord Injuries

Nerve Transfer After Spinal Cord Injury- Multi-center

Start date: April 13, 2020
Phase:
Study type: Observational

Current treatment strategies of acute cervical spinal cord injuries remain limited. Treatment options that provide meaningful improvements in patient quality of like and long-term functional independence will provide a significant public health impact. Specific aim: Measure the efficacy of nerve transfer surgery in the treatment of patients with complete spinal cord injuries with no hand function. Optimize the efficiency of nerve transfer surgery by evaluating patient outcomes in relation to patient selection and quality of life and functional independence.

NCT ID: NCT04017767 Recruiting - Clinical trials for Spinal Cord Injuries

Motor Plasticity, Intermittent Hypoxia and Sleep Apnea

Start date: July 16, 2021
Phase: N/A
Study type: Interventional

The purpose of this study is to learn about the effect of sleep apnea and low oxygen on muscle strength and lung function in people with chronic spinal cord injury.

NCT ID: NCT04015362 Recruiting - Clinical trials for Spinal Cord Injuries

Pulsed Magnetic Stimulation - Managing Spasticity in Spinal Cord Injury

OsStim
Start date: January 2, 2018
Phase: N/A
Study type: Interventional

Spasticity (tightening, spasming and/or contractions of muscles) is a commonly encountered consequence of injuries to the central nervous system. Spasticity has an adverse effect on quality of life and function of patients with spinal cord injuries, stroke and cerebral palsy. Conventional management consists of medication, injections of botulinum toxin and occasionally extensive surgical interventions. Several studies have examined the use of repetitive magnetic stimulation of the brain and of peripheral nerves to produce long-term depression of spasticity. Recently, Theta burst sequence low-dose magnetic stimulation has been shown to mark unused synaptic connections for deletion. By using pulsed magnetic stimulation of the spinal cord the abnormal connections arising from injury may be identified for deletion, therefore potentially minimising the mis-firing circuits. The investigators plan, in this pilot study, to test whether firstly the application of pulsed magnetic stimulation of the spinal cord is achievable in patients with spinal cord injury (SCI) and secondly whether it has an effect on lower limb spasticity. These results will be used to help design a larger trial, to expand the numbers of participants and variety of pathologies treated. Participants (in-patients at the Midland Centre for Spinal Injuries) with stable SCI will be randomised to receive either intermittent pulsed magnetic stimulation or no stimulation. Patients will be blinded as to whether they are receiving stimulation (the machine will be active up and placed in the same position for both groups, except the sham group will have the stimulation coil applied in an orientation that does not deliver the magnetic field to the spinal cord).