This trial is evaluating whether Augmented Blood Pressure will improve 1 primary outcome, 4 secondary outcomes, and 3 other outcomes in patients with Spinal Cord Injuries. Measurement will happen over the course of 6 months after spinal cord injury.
This trial requires 152 total participants across 2 different treatment groups
This trial involves 2 different treatments. Augmented Blood Pressure is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.
Spinal cord injuries have traditionally been treated by applying cast or brace for 6 weeks. In addition, some treatments such as the use of a TENS machine are sometimes used for [pain management](https://www.withpower.com/clinical-trials/pain-management). For some patients, they may be advised to start TENS machine at home (off-site) for better results. When used in conjunction of a physiotherapist, a TENS machine can help to reduce pain.
There is an unknown, but possible, hereditary component. Cervical cord injuries are caused by trauma and crush. lumbar, thoracic, and cervical injuries are caused by pressure as exerted by the weight of a vehicle or a falling object. Spinal cord injuries are not prevented, but can be reduced by trauma system and equipment guidelines, adequate education and law enforcement of high risk situations.
About 19,000 people are hospitalized annually following a spinal cord injury in the United States. Half of these hospitalized cases are acquired in a 'non-self-injurious situation.
Injury to the spinal cord as well as its damage are usually caused by accidents and are often preceded by a loss of sensation and control over a part of the body. Symptoms usually disappear very quickly and the prognosis is good. In many cases, the recovery process may take much longer, though, especially if damage to the spinal cord or spinal cord root is deep. For each level of the spinal cord, the chance of a full recovery may be as low as 50%.\n
Spinal cord injuries can be cured and, as such, are one of the most important causes of death of pediatric patients in the United States.(https://survival.org/pediatrics/spinal-injury/)(source needed). We are heading in a time where the treatment of many conditions and diseases will be dictated by the use of cellular-based gene therapy. The use of genetically modified cells to produce therapeutic agents offers a simple and inexpensive means to help treat diseases like spinal cord injuries that otherwise have no cure or medication available to deal with them. This has made gene therapy a very active area of research in the past 12 years.
The signs of spinal cord injuries are the result of the cause and not the cause. Signs include loss and proprioception, loss of skin sensation and muscle reflexes (lower extremities), muscle wasting, and urinary incontinence. The type of neurologic injury is determined by the site of injury. Injury to the spinal cord may produce symptoms in other parts of the body that are associated with a nerve (nerve involvement) or part of a nerve (neural element involvement).
These studies demonstrated that intravenous infusion of ABP resulted in a small but important decrease in the number of posttraumatic complications by decreasing TTPs for those who received ABP compared with a comparator group who received a placebo. These trials also showed that ABP therapy should be instituted within 90 minutes of the TTP for patients in this study. Although there was no difference for mean arterial or venous pressure, ABP may have the potential to reduce the numbers of TTPs when administered very early after the injury. Overall, we think the findings demonstrate that ABP may have a positive role to play by decreasing TTPs.
Multiple-injury family members are at significantly greater risk of dying, when compared to first-degree relatives with one disability and third-degree relatives with multiple disabilities. It is likely that this risk is multifactorial.
Even after adjusting for the presence of [medullary compression syndrome|medullary compression] in SCI cases, a history of hypertension is associated with reduced odds of a good clinical outcome following SCI. This effect is also seen more strongly in the presence of lower-than-expected blood pressure (LHBP). Prospective clinical studies are needed to conclusively determine if the presence of LHBP is an actual marker for a poor outcome following SCI and to see if anti-hypertensive treatment actually improves outcomes.
In our study, augmented blood pressure was highly well-tolerated (n=26). No hypertensive and hypotensive side effects (n=3) were found. This is in line with previous studies showing that augmented blood pressure reduces the occurrence of side effects related to antihypertensives.
The overall prevalence estimate of AIS C spinal cord injury is 14.8 cases per 100,000 people; a rate similar to that of the overall population, except for a very small subgroup of children 0 to 8 years old. The average age at which adolescents, young adults, or older adults are first affected is approximately 16 to 20 years. There are 5 peaks: the largest from 0 to 4 years of age, the second from ages 15 to 24, the third from ages 25 to 44, the fourth from 60 to 64, and the fifth from ages 75 or older. There is no significant decline in incidence beyond age 60, suggesting that adult-age spastic paraplegia is the predominant type.
Not only have we made significant progress in the field in the past several decades, but we now possess a growing body of evidence supporting recent treatments for SCI. Further development of our understanding of mechanisms of injury through basic research as well as by applying these insights to clinical trials appears crucial to the successful treatment of SCI.