Randomised, double-blind, placebo-controlled, parallel-group, multicentric, phase IIA clinical trial for evaluating the safety, tolerability, and therapeutic efficacy of daily oral administration of NFX88 to treat neuropathic pain in individuals with spinal cord injury.

STUDY DESIGN: Double-blind, randomized, placebo-controlled, parallel-group multicentric phase IIA clinical trial. OBJECTIVE: To assess the safety and tolerability of oral administration of NFX-88 in subjects with chronic spinal cord injury (SCI) and explore its efficacy in pain control. SETTING: A total of 7 spinal cord injury rehabilitation units in Spain. METHODS: A total of 61 adult with traumatic complete or incomplete spinal cord injury (C4-T12 level), were randomised 1:1:1:1 to a placebo, NFX88 1.05 g, 2.1 g, 4.2 g/day for up to 12 weeks. The placebo or NFX-88 was administered as add-on therapy to pre-existing pregabalin (150-300 mg per day). Safety and tolerability were evaluated, and the Visual Analogue Scale (VAS) was the primary measure to explore the efficacy of NFX-88 in pain control. RESULTS: No severe treatment-related adverse effects were reported for any of the four study groups. 44 SCI individuals completed the study and were analysed. The data obtained from the VAS analysis and the PainDETECT Questionnaire (PD-Q) suggested that the combination of NFX88 with pregabalin is more effective than pregabalin with placebo at reducing neuropathic pain (NP) in individuals with SCI and that the dose 2.10 g/day causes the most dramatic pain relief. CONCLUSIONS: NFX88 treatment was found to be highly safe and well tolerated, with the dose of 2.10 g/day being the most effective at causing pain relief. Thus, the promising efficacy of this first-in-class lipid mediator deserves further consideration in future clinical trials.

Assessing user experience with BMI-assisted exoskeleton in patients with spinal cord injury.

Spinal Cord Injury (SCI) refers to damage to the spinal cord that can affect different body functionalities. Recovery after SCI depends on multiple factors, being the rehabilitation therapy one of them. New approaches based on robot-assisted training offer the possibility to make training sessions longer and with a reproducible pattern of movements. The control of these robotic devices by means of Brain-Machine Interfaces (BMIs) based on Motor Imagery (MI) favors the patient cognitive engagement during the rehabilitation, promoting mechanisms of neuroplasticity. This research evaluates the acceptance and feedback received from patients with incomplete SCI about the usage of a MI-based BMI with a lower-limb exoskeleton. Clinical Relevance- Patients experienced satisfaction when using the exoskeleton and levels of mental and physical workload were withing reasonable limits. In addition results from the BMI were promising for the inclusion of this type of systems in rehabilitation programs.

Usability and acceptance of using a lower-limb exoskeleton controlled by a BMI in incomplete spinal cord injury patients: a case study.

Spinal cord injury (SCI) limits life expectancy and causes a restriction of patient's daily activities. In the last years, robotics exoskeletons have appeared as a promising rehabilitation and assistance tool for patients with motor limitations, as people that have suffered a SCI. The usability and clinical relevance of these robotics systems could be further enhanced by brain-machine interfaces (BMIs), as they can be used to foster patients' neuroplasticity. However, there are not many studies showing the use of BMIs to control exoskeletons with patients. In this work we show a case study where one SCI patient has used a BMI based on motor imagery (MI) in order to control a lower limb exoskeleton that assists their gait.

Physical activity and transcutaneous oxygen pressure in men with spinal cord injury.

This pilot study proposed a method for assessing the status of vascular flow measured by transcutaneous oxygen pressure (TcPO2) in the area of the ischium in people with spinal cord injury (SCI). In a sample of 38 men (two groups: 12 physically active and 26 sedentary) with thoracic SCI, the distribution of the physiological response of the tissues under load during sitting was assessed through analysis of ischium TcPO2 values obtained by an oximeter. TcPO2 baseline, recovery time of TcPO2 after sitting (Trec), the percentage of TcPO2 (%TcPO2) of maximum pressure TcPO2, and mechanic maximal pressure (Pmax) were evaluated. Trec in the physically active group was significantly lower (p < 0.05) than in the sedentary group. Likewise, significant differences in %TcPO2 between groups (p < 0.05) were also found. We concluded that the physiological response of the tissues under an individual with SCI's own weight resulting from prolonged sitting is better in those who are physically active.

Relation between kinematic analysis of wheelchair propulsion and wheelchair functional basketball classification.

The objective was to conduct a methodological pilot study to analyze wheelchair propulsion upper limb kinematics in standard competitive play considering the functional classification of each athlete. Ten basketball players with a functional classification ranging from 1 to 4 were included in the study. Four camcorders (Kinescan-IBV) and a treadmill for wheelchairs were used. Temporal parameters were analyzed and the upper limb kinematics was obtained using ISB recommendations. The value of the temporal parameters such as push phase duration, the ratio of push phase/recovery phase, contact, and propulsion angle seems to reduce as the functional classification increases. A methodological protocol has been developed that allows the analysis of kinematic characteristics of wheelchair propulsion in basketball players taking into account their functional classification.