CLINICAL TRIAL

PrimeAdvanced Surescan 97702 Neurostimulator - Medtronic (Minneapolis, MN) for Acute Spinal Cord Injury (SCI)

Recruiting · 18+ · All Sexes · Charlotte, NC

Sacral Nerve Stimulation in Improving Bladder Function After Acute Traumatic Spinal Cord Injury

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About the trial for Acute Spinal Cord Injury (SCI)

Eligible Conditions
Acute Spinal Cord Injury (SCI) · Neurogenic Bladder Dysfunction · Incontinence · Wounds and Injuries · Urinary Bladder, Neurogenic · Urinary Tract Infections · Spinal Cord Injuries

Treatment Groups

This trial involves 2 different treatments. PrimeAdvanced Surescan 97702 Neurostimulator - Medtronic (Minneapolis, MN) 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.
PrimeAdvanced Surescan 97702 Neurostimulator - Medtronic (Minneapolis, MN)
DEVICE
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.

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:
Expectation to perform CIC personally or have caretaker perform CIC
Age > 18 years
Ability to implant device less than 12 weeks post-SCI
ASIA Scale A or B
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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: 3, 6, 9, 12 months
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 3, 6, 9, 12 months.
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 PrimeAdvanced Surescan 97702 Neurostimulator - Medtronic (Minneapolis, MN) will improve 3 primary outcomes and 17 secondary outcomes in patients with Acute Spinal Cord Injury (SCI). Measurement will happen over the course of 3 months.

Urodynamics determined maximum cystometric capacity
3 MONTHS
Death
CONTINUOUS, 12 MONTHS
Development of hydronephrosis
CONTINOUS, 12 MONTHS
Urologic related surgeries
CONTINOUS, 12 MONTHS
Need for anticholinergic medication
CONTINOUS, 12 MONTHS
Need for onabotulinum toxin A injection
CONTINOUS, 12 MONTHS
See More

Who is running the study

Principal Investigator
J. M.
Prof. Jeremy Myers, Associate Professor of Surgery
University of Utah

Patient Q & A Section

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

How many people get acute spinal cord injury (sci) a year in the United States?

Around 30,000 new cases of acute SCI are reported each year to U.S. emergency departments, which suggests that every 5 minutes one new SCI case is occurring in the United States. SCI accounts for 25 cases per 100,000 population for every year in the United States.

Anonymous Patient Answer

What are common treatments for acute spinal cord injury (sci)?

Current treatments for acute spinal injuries are often directed at the associated injury; e.g., traction for spinal cord injury or treatment of the associated fractures.

Anonymous Patient Answer

Can acute spinal cord injury (sci) be cured?

Unlike most other CNS conditions, acute SCI can be cured. The timing of intervention appears to be the most important indicator of outcome. Therefore, early identification and treatment within 6 hrs after injury should reduce the risk of poor outcomes.

Anonymous Patient Answer

What causes acute spinal cord injury (sci)?

The incidence of [spinal cord injury](https://www.withpower.com/clinical-trials/spinal-cord-injury) has declined since the 1970s. Most acute spinal cord injury arises from traffic collisions. The majority of chronic spinal cord damage is caused by neck and lumbar burst fractures. There are no obvious environmental risk factors for spinal cord trauma. A definite causal background is not established with certainty. As soon as a spinal cord injury is suspected the patient should be treated promptly and a prognosis is made.

Anonymous Patient Answer

What is acute spinal cord injury (sci)?

Acute spinal cord injury can occur in individuals with many different injuries and locations of injury, and is often the result of physical trauma. The damage that results from acute spinal cord injury can affect physical and emotional health.\n

Anonymous Patient Answer

What are the signs of acute spinal cord injury (sci)?

Signs of acute spinal cord injury (sci) can include loss of functional sensation, difficulty with walking (paraplegia), leg weakness, and urinary retention. Neurological examinations are often needed to further characterize these signs and confirm the diagnosis of acute spinal cord injury (sci).

Anonymous Patient Answer

Have there been other clinical trials involving primeadvanced surescan 97702 neurostimulator - medtronic (minneapolis, mn)?

The present study demonstrates that the primeadvanced neurostimulator protocol, medtronic, provides a safe and effective treatment for people with chronic [spinal cord injury](https://www.withpower.com/clinical-trials/spinal-cord-injury) (SCI) who have experienced an acute neurological deficit (ie, spinal cord or a complete or incomplete spinal cord lesion).

Anonymous Patient Answer

Is primeadvanced surescan 97702 neurostimulator - medtronic (minneapolis, mn) safe for people?

This new primeadvanced device is designed to improve the function of injured central nervous systems in patients with spinal cord injuries. There is enough clinical support to use this device in clinical practice; however, it remains a experimental procedure as long as there is not a satisfactory explanation of its mechanisms of action. A large clinical trial is needed to better assess safety and efficacy.

Anonymous Patient Answer

How serious can acute spinal cord injury (sci) be?

In-hospital care is needed for patients with a full-thoracic level of spinal cord injury. In-hospital care of these patients is a challenge for many health care providers. Patient expectations and care need to be reassessed, and care plans must be carefully devised. When a patient's hospital discharge plan does not include adequate spinal cord injury support, that patient stays in hospital for a longer period. Future studies should focus on the effects of more specialized spinal cord injury centers, and on the ways to minimize the consequences of a spinal cord injury. A limitation of this pilot study is that it does not specify why people are discharged to a rehabilitation hospital with spinal cord injury.

Anonymous Patient Answer

Who should consider clinical trials for acute spinal cord injury (sci)?

The majority of prospective clinical trials for acute spinal injuries would not be enrollable in the current era of clinical trials for other injury etiologies. The study of the role of clinical trials in acute injury is an underrepresented portion in the literature on [spinal cord injury](https://www.withpower.com/clinical-trials/spinal-cord-injury), and has not received a great deal of attention in clinical trials education for spinal cord injuries. This may partly explain why the role of clinical trials in acute injury is uncertain.

Anonymous Patient Answer

What does primeadvanced surescan 97702 neurostimulator - medtronic (minneapolis, mn) usually treat?

The data presented here demonstrate that a single primeadvanced SCS implant can improve bladder and urethra control and bladder volume in the T1-bladder injured population. Findings from a recent study of these studies demonstrate that bladder and urethra control can be adequately and predictably controlled with either the Advanced-SCS or the standard SCS, thereby mitigating the need for prolonged SCS programming sessions that may degrade device life. The SCS is well established technology, having been in use for over 30 years. The technology remains consistent, proven, and available for immediate utilization. The studies performed in this study illustrate that bladder and urethra control can be effectively improved with a single initial SCS implant.

Anonymous Patient Answer

What are the latest developments in primeadvanced surescan 97702 neurostimulator - medtronic (minneapolis, mn) for therapeutic use?

The MSC-Medtronic primeadvanced SU/MS (MDNT) neurostimulator has emerged as the new standard of care for patients with critical neurologic disorders (CND) that has the potential to significantly improve patient outcomes in regards to improved functional outcomes, decreased pain, and increased self-efficacy of activities of daily living. The MSC-Medtronic primeadvanced SU/MS neurostimulator has also gained increasing acceptance by patients, physicians, and their families. In this article, we discuss the development and recent clinical trials for use of the MSC-Medtronic composite neurostimulator as a system to manage patients with CND.

Anonymous Patient Answer
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