CLINICAL TRIAL

Neuro-Spinal Scaffold for Spinal Cord Injuries

Recruiting · Any Age · All Sexes · Pittsburgh, PA

This study is evaluating whether a spinal implant may help individuals with spinal cord injuries.

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About the trial for Spinal Cord Injuries

Eligible Conditions
Wounds and Injuries · Spinal Cord Injuries · Spinal Cord Injuries (SCI) · Spinal Injuries

Treatment Groups

This trial involves 2 different treatments. Neuro-Spinal Scaffold 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.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Neuro-Spinal Scaffold
DEVICE
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.

Eligibility

This trial is for patients born any sex of any age. There are 9 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
The patient must have a Glasgow Coma Scale score of at least 14 (10 for intubated subjects) at the time of the screening and a score of at least 15 (10 for intubated subjects) within two hours prior to spine surgery. show original
is significantly associated with incomplete motor recovery If you have a non-penetrating SCI (contusion injury) that is at least 4 mm in diameter, you are likely to have incomplete motor recovery. show original
AIS A classification of traumatic spinal cord injury at T2 - T12 neurological level of injury confirmed by a qualified medical professional
The person must have had an open spine surgery within the past seven days. show original
The patient has a low Injury Severity Score and is not likely to have a serious injury. show original
Any person who needs surgery to access their injured spinal cord will be eligible for this study show original
Informed consent obtained
People who are 16 to 70 years old, inclusive, can use the library. show original
A blood pressure above 90 mmHg for eight hours prior to surgery is considered to be hemodynamically stable. show original
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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
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: 72-hours, 3-months, 6-months, 12-months, and 24-months post-open spine surgery
Screening: ~3 weeks
Treatment: Varies
Reporting: 72-hours, 3-months, 6-months, 12-months, and 24-months post-open spine surgery
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 72-hours, 3-months, 6-months, 12-months, and 24-months post-open spine surgery.
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 Neuro-Spinal Scaffold will improve 1 primary outcome and 10 secondary outcomes in patients with Spinal Cord Injuries. Measurement will happen over the course of 6 months post-implant.

Change in AIS grade of one or more levels
6 MONTHS POST-IMPLANT
The proportion of subjects with an improvement of at least one AIS grade will be presented for each study arm. The International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) examinations determine the ASIA Impairment Scale (AIS) grade.
6 MONTHS POST-IMPLANT
Changes in bladder, bowel, and sexual function
6-MONTHS, 12-MONTHS AND 24-MONTHS, POST-OPEN SPINE SURGERY
Bladder, bowel and sexual function will be assessed using the Lower Urinary Tract, Bowel and Sexual Function System/Organ section of the ASIA Autonomic Standards Assessment Form. The Autonomic Standards Assessment Form has three questions in each category (Lower Urinary Tract or bladder, Bowel, Sexual Function) and each question is scored on a scale from 0 (complete loss of control) - 2 (normal function). Observed values and change from baseline will be presented for each study arm. The hospital discharge visit will be used as the baseline visit.
6-MONTHS, 12-MONTHS AND 24-MONTHS, POST-OPEN SPINE SURGERY
Change in Neurological Level of Injury (NLI)
3-MONTHS, 6-MONTHS, 12-MONTHS, 24-MONTHS POST-OPEN SPINE SURGERY
The ISNCSCI examinations determine the the Neurological Level of Injury (NLI). The NLI refers to the most caudal segment of the spinal cord with normal sensory and antigravity motor function on both sides of the body, provided that there is normal (intact) sensory and motor function rostrally. NLI will be summarized for each study arm at visits (pre-surgery, 3-months, 6-months, 12-months, 24-months). Observed values and change from the baseline will be presented for each study arm.The ISNCSCI exam performed within 8 hours prior to surgery (pre-surgery ISNCSCI) will be used as the baseline.
3-MONTHS, 6-MONTHS, 12-MONTHS, 24-MONTHS POST-OPEN SPINE SURGERY
Change in motor scores
3-MONTHS, 6-MONTHS, 12-MONTHS, 24-MONTHS POST-OPEN SPINE SURGERY
A numerical summary score of motor function in each extremity determined by the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) examination. This score can reflect the degree of neurological impairment associated with the SCI, with lower score indicating greater impairment. Score ranges from 0-25 for each extremity, with maximum scores of 50 for the upper limbs and 50 for the lower limbs. Motor scores will be summarized for each study arm at visits (pre-surgery, 3-months, 6-months, 12-months, 24-months). Observed values and change from the baseline will be presented for each study arm.The ISNCSCI exam performed within 8 hours prior to surgery (pre-surgery ISNCSCI) will be used as the baseline.
3-MONTHS, 6-MONTHS, 12-MONTHS, 24-MONTHS POST-OPEN SPINE SURGERY
Change in sensory scores
3-MONTHS, 6-MONTHS, 12-MONTHS, 24-MONTHS POST-OPEN SPINE SURGERY
A numerical summary score of sensory function in each determined by the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) examination. This score can reflect the degree of neurological impairment associated with the SCI, with lower score indicating greater impairment. Score ranges from 0-56 points each for light touch and pin prick (sharp/dull discrimination) modalities, with a maximum total score of 112 points per side of the body. Observed values and change from the baseline will be presented for each study arm.The ISNCSCI exam performed within 8 hours prior to surgery (pre-surgery ISNCSCI) will be used as the baseline.
3-MONTHS, 6-MONTHS, 12-MONTHS, 24-MONTHS POST-OPEN SPINE SURGERY
Changes in spinal cord anatomy-Presence of cyst
72-HOURS, 3-MONTHS, 6-MONTHS, 12-MONTHS, AND 24-MONTHS POST-OPEN SPINE SURGERY
Cyst presence or absence will be assessed by an independent board-certified neuroradiologist central reader. Observed values and change from baseline will be presented for each study arm. The Screening MRI will be used as the baseline.
72-HOURS, 3-MONTHS, 6-MONTHS, 12-MONTHS, AND 24-MONTHS POST-OPEN SPINE SURGERY
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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 are the signs of spinal cord injuries?

Weakness or loss of sensation, or muscle spasm, may be the only signs of spinal cord injuries. Some other signs include a reduced bladder reflex, bowel and urinary incontinence and paralysis of external genitalia and internal genitals such as the penis and scrotum. A diagnosis can be confirmed only by a magnetic resonance myelogram.

Anonymous Patient Answer

What are common treatments for spinal cord injuries?

Many treatments are available for spinal cord injuries. Rehabilitation in the early stage of recovery is important. Spinal cord injury may necessitate surgical decompression. Steroids are commonly used.

Anonymous Patient Answer

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

Of the 25,000 Americans annually who sustained an SCI at least 1 year before the analysis, approximately 11,000 would have developed a motor deficit and 18,000 would have an FIM score above 20 which is probably attributable to motor deficits. The FIM score is an important tool in facilitating post-injury rehabilitation planning and providing discharge planning. As more research is done, further refinements seem warranted.

Anonymous Patient Answer

What is spinal cord injuries?

Spinal cord injury is a wide term encompassing disabling and fatal diseases of the spinal cord and can be caused by a number of causes including trauma, stroke and infectious diseases. Most of the reported cases of spinal cord injuries are related to traffic accidents. The prognosis of the SCI is very poor. Spinal cord injuries can lead to disability, dependency and often death. However, the death rate has significantly decreased over the last three decades due to the improved survival of spinal cord trauma patients. The main causes of death are infection, respiratory distress and anemia"

"Nacoleia cuspialis\n\nNacoleia cuspialis is a moth in the family Crambidae.

Anonymous Patient Answer

Can spinal cord injuries be cured?

As SCI patients suffer from severe complications (particularly multiple organ dysfunction syndrome [MODS]) resulting from their own injuries, the ability of SCI to cure itself is highly unlikely. However, new research and better understanding of SCI will likely provide additional insight into potential cure or treatment for the disorder.

Anonymous Patient Answer

What causes spinal cord injuries?

The risk of sustaining a spinal cord injury due to an accidental or penetrating injury is very small. However, if a spinal cord injury occurs, the recovery process is slow.

Anonymous Patient Answer

Is neuro-spinal scaffold safe for people?

Overall, there was no evidence to suggest that the use of SPARs is an acceptable or safe form of treatment for the management and rehabilitation of traumatic spinal cord injury sufferers. However, further studies are warranted to determine whether application of SPARs is safer than traditional therapies, or whether SPAR use poses greater or different risks of serious complications for traumatic spinal cord injury sufferers to those undergoing traditional treatments.

Anonymous Patient Answer

Does neuro-spinal scaffold improve quality of life for those with spinal cord injuries?

NeuroSpa significantly improved a series of outcome measures for participants with spinal cord injury and can be considered as a useful addition to standardized assessments.

Anonymous Patient Answer

Have there been any new discoveries for treating spinal cord injuries?

Although there are many kinds of treatments that have been shown to improve outcomes of patients with SCI, none have been proven to be complete. There continues to be a lot to discover for the treatment of SCI.

Anonymous Patient Answer

What is the latest research for spinal cord injuries?

The spinal cord injury literature is ever changing, as some recent studies have been positive and many recent studies have been negative that suggest the need for more work to determine the mechanisms of spinal cord injury. While there are some positive findings, the negative findings are still quite numerous. In the past, the literature showed positive results for most of the treatments, but the literature showed mixed results in recent journals. While not all of the research has positive outcomes, it is clear that the information that is now available is much more complete than it has been in the past and will continue to get better (with more clinical trials underway).

Anonymous Patient Answer

What are the latest developments in neuro-spinal scaffold for therapeutic use?

[With advances made in scaffold design and materials (e.g. biocompatibility and biodegradability of the scaffolds, biomimetic properties] combined with advancement in nanobiotechnology and nano-fabrication techniques, biomimetic scaffolds have reached a state of readiness for clinical deployment.

Anonymous Patient Answer

Who should consider clinical trials for spinal cord injuries?

Individuals with spinal cord injury (SCI) and clinical trial eligibility criteria may differ by age and sex due to medical and sociodemographic-related conditions which affect trial enrollment. A process of case selection and assessment of eligibility is needed to identify eligible individuals with SCI for clinical trials. Inclusion of individuals on clinical trial eligibility criteria who are ≥55 years of age, female, or persons with a disability may allow for a broader representation of relevant patient populations in clinical trials.

Anonymous Patient Answer
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