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Spinal Cord Injuries clinical trials

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NCT ID: NCT02923817 Recruiting - Clinical trials for Spinal Cord Injuries

Clinical Trial Using Bone Marrow-derived Mononuclear Cells for Spinal Cord Injury

DNH
Start date: September 2016
Phase: Phase 2
Study type: Interventional

The purpose of study is to determine whether autologous mononuclear cells deriving from the bone marrow are effective in the treatment of spinal cord injury.

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: NCT02917291 Recruiting - Clinical trials for Acute Traumatic Spinal Cord Injury

Safety and Preliminary Efficacy of FAB117-HC in Patients With Acute Traumatic Spinal Cord Injury

SPINE
Start date: December 2016
Phase: Phase 1/Phase 2
Study type: Interventional

The main objective of the study is the evaluation of the safety and tolerability of FAB117-HC (a medicinal product containing human allogeneic adipose derived adult mesenchymal stem cells expanded and pulsed with H2O2, HC016 cells) administered at a single-time point to patients with acute thoracic traumatic spinal cord injury (SCI). The study will also include initial exploration of potential clinical efficacy. Dose levels of 20 million and 40 million cells will be administered.

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.

NCT ID: NCT02859792 Recruiting - Spinal Cord Injury Clinical Trials

Riluzole in the Treatment of Spasticity in the Traumatic Chronic Spinal Cord Injury Condition

RILUSCI
Start date: May 27, 2019
Phase: Phase 2
Study type: Interventional

The study will be conducted in two steps: 1. Determination of the Minimal Effective Dose (MED) among the four doses of the panel 2. Estimation of the probability of response associated to the MED. Each step has a main objective: Step 1 Objective: To determine a daily dose of Riluzole that improves spasticity in patients with chronic SCI Step 2 Objective: To demonstrate, in a phase 2b trial, the efficacy of Riluzole to improve spasticity vs placebo, in patients with chronic SCI.

NCT ID: NCT02808078 Recruiting - Stroke Clinical Trials

Gait Adaptation for Stroke Patients With Augmented Reality

GASPAR
Start date: June 2016
Phase: N/A
Study type: Interventional

The GASPAR trial is a pragmatic, parallel-arms, single-center, non-blinded, superiority randomized control trial in neurorehabilitation. The main objective is to test whether a 4 weeks gait rehabilitation program that uses augmented reality is superior to a conventional treadmill training program of equivalent intensity. Baseline assessments precede allocation, which consists in blocking randomization (2:1 ratio) with stratification according to the disease etiology. Post-intervention assessments serve to compare the short-term efficacy of the intervention between the two groups. Three months after discharge, follow-up assessments take place to detect potential long-term effects.

NCT ID: NCT02721615 Recruiting - Clinical trials for Spinal Cord Injuries

Injured Spinal Cord Pressure Evaluation

ISCoPE
Start date: September 2010
Phase: N/A
Study type: Interventional

About a thousand people a year in the United Kingdom survive a spinal cord injury but are left paralysed or wheelchair-bound. The annual cost of care for spinal cord injury victims is more than half a billion pounds. We propose that after spinal cord injury, cord pressure at the injury site rises, damaging the spinal cord further by secondary ischaemia. The value of measuring and reducing cord pressure after spinal cord injury is unknown. The injured spinal cord is compressed by bone malalignment and cord swelling. Current management involves realigning and fixing the bony fragments using metal screws, rods and plates. We hypothesise that: 1. Bony realignment alone does not adequately decompress the swollen cord, which remains compressed against the surrounding dura. 2. That duraplasty reduces intra spinal pressure more effectively than bone realignment alone. 3. Localised hypothermia reduces intra spinal pressure and improves metabolism. We will develop a novel method to measure cord pressure and metabolism at the injury site after spinal cord injury and determine whether the cord pressure rises, for how long, and with what impact on spinal cord metabolism. This is a pilot study to find out whether spinal cord pressure and metabolism can be measured after spinal cord injury and whether they are effected by treatment choices. We will examine if spinal cord perfusion pressure correlates with clinical outcomes.

NCT ID: NCT02687672 Recruiting - Spinal Cord Injury Clinical Trials

Transplantation of Autologous Bone Marrow or Leukapheresis-Derived Stem Cells for Treatment of Spinal Cord Injury

Start date: January 2016
Phase: Phase 2
Study type: Interventional

This is a double-armed, Phase I/II trial aims to compare bone marrow and leukapheresis as sources for purified, autologous CD34+ and CD133+ stem cells (SCs), to be utilized in treatment of patients with chronic complete spinal cord injuries (SCI). The study focuses on the safety and efficacy of transplanting un-manipulated, autologous, purified stem cells into the injured spinal cords of patients.

NCT ID: NCT02672670 Recruiting - Spinal Cord Injury Clinical Trials

Effects of a Coping-oriented Supportive Programme (COSP) for People With Spinal Cord Injury During Inpatient Rehabilitation

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

The aim of this proposed PhD study is to test the effectiveness of a newly developed coping-oriented supportive programme (COSP) for Chinese people with SCI during their early period of inpatient rehabilitation in Xi'an, China. The objectives of this study are to develop and validate the COSP in the inpatient rehabilitation hospitals; and to evaluate the effectiveness of this COSP for the SCI inpatients in two rehabilitation wards on their coping abilities, self-efficacy, mood status, and life satisfaction, when compared to those receiving routine care in another two rehabilitation wards. This proposed PhD study is a quasi-experimental study, using repeated-measures, comparison group design. The study will be conducted in two rehabilitation hospitals in Xi'an, China. There will be 50 patients in each of the two study groups (i.e., one intervention and one comparison group). The intervention group will receive the COSP including 8 weekly sessions, and the comparison group will receive usual rehabilitation care in brief didactic group-based education. Outcome measures will be examined at baseline and immediately, 1- and 3-month after completion of the interventions. The primary outcomes of this proposed study are coping ability and self-efficacy, while the secondary outcomes include mood status, life satisfaction, and pain. All data will be analysed using SPSS for Windows, version 21.0. Descriptive statistics will be employed for demographic and disease-related data and outcome scores. Data analysis for intervention effects will be based on both Per-protocol (PP) analyses and Intention-To-Treat (ITT). The missing data will be handled by the Last Observation Carried Forward (LOCF) strategy. Inferential statistics will be conducted for between-group and within-group comparison with specific considerations with the measurement level of the data and the fulfillment of the statistical assumptions of parametric or non-parametric tests, and further consider to use multivariate analysis of covariance (MANCOVA) or the analysis of covariance (ANCOVA).This study will provide evidence on the clinical effectiveness of the coping-oriented supportive programme in improving patients' psychological adjustment to SCI during earlier stage of inpatient rehabilitation, enhancing their psychosocial adaptation to the illness and subsequent life satisfaction and hence, integrating this psychosocial intervention into the conventional treatment and SCI rehabilitation practices.

NCT ID: NCT02663310 Recruiting - Clinical trials for Spinal Cord Injuries

Treatment for Chronic Spinal Cord Injury: Surgery With Rehabilitation vs Rehabilitation

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

The purpose of this study is to investigate the efficacy of surgical decompression/untethering, combined with weight bearing rehabilitation, on neurological recovery following chronic spinal cord injury.