CLINICAL TRIAL

Paraspinal for Spinal Cord Injuries

Recruiting · 18+ · All Sexes · Dubai, United Arab Emirates

This study is evaluating whether a combination of stem cell injections and virtual reality may help individuals with spinal cord injuries.

See full description

About the trial for Spinal Cord Injuries

Eligible Conditions
Paraparesis · Paraplegia, Spinal · Spinal Cord Compression · Spinal Paralysis · Ischemia · Paraplegia; Traumatic · Spinal Cord Injuries · Spinal Cord Injuries (SCI) · Spinal Cord Diseases · Paralysis · Paraplegia · Spinal Cord Ischemia · Wounds and Injuries · Paraplegia/Paraparesis

Treatment Groups

This trial involves 3 different treatments. Paraspinal is the primary treatment being studied. Participants will be divided into 3 treatment groups. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Experimental Group 1
Paraspinal
PROCEDURE
+
Paraspinal VR
PROCEDURE
Experimental Group 2
Paraspinal
PROCEDURE
Experimental Group 3
Paraspinal
PROCEDURE
+
Paraspinal EX
PROCEDURE

Eligibility

This trial is for patients born any sex aged 18 and older. There are 5 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
If the person is stable on their current pharmacologic or surgical treatment and the spinal cord damage is not likely to get worse with the current treatment, then they would not be a good candidate for a DBS. show original
There is evidence of functional damage to the spinal cord that is not likely to improve with the current standard of care. show original
In the estimation of Dr. Weiss and Dr. Silberfarb have the potential for improvement with BMSC treatment and be at minimal risk of any potential harm from the procedure.
View All
Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
Similar Trials

Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: 1,3,6,12 months post-procedure
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 1,3,6,12 months post-procedure.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Paraspinal will improve 1 primary outcome and 2 secondary outcomes in patients with Spinal Cord Injuries. Measurement will happen over the course of Pre-procedure, 1,3,6 and 12 months post-procedure.

American Spinal Injury Association (ASIA) Impairment Scale (AIS)
PRE-PROCEDURE, 1,3,6 AND 12 MONTHS POST-PROCEDURE
AIS is based on the Frankel scale which is used to classify the degree or completeness of spinal cord injury (SCI) by assessing motor and sensory function. Patients will have AIS assessment prior to procedure and post-procedure for comparison and identification of any improvements in motor or sensory function.
Autonomic Nervous System (ANS) Function
1,3,6 AND 12 MONTHS POST-PROCEDURE
The autonomic nervous system (ANS) through the sympathetic and parasympathetic divisions is responsible for many functions of the body including bladder and bowel control and sweating. Patients will self-report changes in ANS function and their abilities to perform ANS functions following the procedure.
General Well-Being
1,3,6,12 MONTHS POST-PROCEDURE
General Well-Being is a term that may encompass mood, sense of well-being, family relationships, ability to do daily tasks and other practical or emotional practices that vary from person to person. Patients will self-report changes in their Quality of Life

Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What causes spinal cord injuries?

Spinal cord injuries result from trauma to the spine. The spine is the most susceptible to injury due to high mechanical stress and low blood perfusion. The cervical spine is most commonly injured due to impact or collision. The most severe injuries are usually sustained by high-impact sports. Injuries occur during leisure activities, such as bicycling, riding scooters, skateboarding, boating, or horseback riding. Most incidents involve the thoracic spine, followed by those in the cephalic and lumbosacral spine, with only slightly more injuries occurring in the thoracic and the lumbosacral spine. The incidence of thoracic fractures in patients is increasing. Most injuries are sustained by adults.

Anonymous Patient Answer

How many people get spinal cord injuries a year in the United States?

About 3.6 million people in the United States are currently being treated for spinal cord injuries. This is over 25% of all U.S. neurologic disorders. Spinal cord injury occurs at a rate of one every 4,100-10,000 live births. Of those who have an injury, 40% will not have full recovery or complete functional independence. Survival rates with good functional independence and with complete or excellent recovery are 40%. Survival and functional outcome in the population without injury is approximately 95%. About 30% of these injuries recover without treatment over 6 to 12 months. Spinal cord injury is the third most common cause of death in the United States.

Anonymous Patient Answer

What is spinal cord injuries?

The severity of spinal cord injuries varied considerably and the quality of life of patients was compromised by multiple factors. Spinal Cord Injury (SCI) is a major health issue and the number of people affected is increasing. The disability and financial loss are significant. The aim of this article is to raise awareness of the SCI, to the general public, the healthcare professionals, and the government.

Anonymous Patient Answer

What are common treatments for spinal cord injuries?

Spinal cord injury was mostly treated in a conservative fashion. There are a few cases where surgery was considered on patients who had chronic complications due to the spinal cord injuries but none were reported. There have been a lot of advancements in medical treatment in the last years with the treatment of acute, chronic neurological deficits in adults. However, the treatment of spinal cord injuries still remains a very complicated and challenging procedure.

Anonymous Patient Answer

What are the signs of spinal cord injuries?

The onset of a traumatic cord injury involves more than one organ system. The signs of an achromic cord injury include the absence of a radial pulse and a decrease in tone above C6. There are several signs of an anesthetic cord injury that include absent peripheral pulses and diminished sensation or weakness above the level of injury (below C9). Caudal cord injury signs include decreased leg muscle tone and diminished sensation below T6.

Anonymous Patient Answer

Can spinal cord injuries be cured?

Spinal cord injury can be a devastating event not only for the victims but also for their families. Families often struggle tremendously in their coping process after the death of a loved one due to the fact that they are unable to do or control the usual routines necessary for their daily living. In some instances, families may experience the same kind of problems with their coping that their loved ones experienced before they died. When a family is unable to find help, the only option is for them to accept these issues alone. While in some cases, it might be possible for some injuries to be cured, there is no way of determining what the outcome will be.

Anonymous Patient Answer

How does paraspinal work?

Spinal work is a component of spinal functional compensation. It is used during weight bearing postimplant, which may account for the high number of posttraumatic complications. In contrast to most experimental models, the present study found that spinal work did not increase intrafascicular pressures after weight bearing postimplant in our small animal model.

Anonymous Patient Answer

Have there been other clinical trials involving paraspinal?

There have been several clinical trial involving paraspinal nerve blocks. There is no evidence that such trials have shown any benefit. More attention is needed to encourage a search for new ways to help patients with pain related to injury.

Anonymous Patient Answer

Has paraspinal proven to be more effective than a placebo?

This pilot study is the first to compare the effectiveness of paraspinal to a placebo regimen in a population of individuals with incomplete TSC. Results from a recent clinical trial of this study demonstrate that paraspinal was ineffective in reducing CINV and opioid use and was not more effective than placebo in reducing analgesic and opiate usage with complete or incomplete TSC.

Anonymous Patient Answer

What is the latest research for spinal cord injuries?

This review highlights the recent advances in spinal cord injury biology and potential opportunities for therapy. In the future, the emerging biological models of neuronal regeneration may offer an excellent strategy to enhance recovery after a contusive injury.

Anonymous Patient Answer

What is paraspinal?

What is paraspinous? answer: This is one way to think about the anatomy of the spine with respect to the paraspinous muscles. The most common location of the muscles of the neck in relation to the spine is posterior to the sternocleidomastoid muscle. This concept deserves consideration in the treatment of neck pain. In addition, the term paraspinal may be applied in broader terms to all muscles of the back (see spine).

Anonymous Patient Answer

Is paraspinal typically used in combination with any other treatments?

This meta-analysis shows that paraspinal is one of the most frequently used anesthetics in spine surgery. However, its usage varies widely, which has a major impact on the outcome of the operation; paraspinal can exacerbate both the surgical environment and the degree of analgesia and anesthesia provided to the patient postoperatively.

Anonymous Patient Answer
See if you qualify for this trial
Get access to this novel treatment for Spinal Cord Injuries by sharing your contact details with the study coordinator.