CLINICAL TRIAL

Temporary Peripheral Nerve Stimulator for Nerve Injury

Recruiting · 18+ · All Sexes · Hamilton, Canada

This study is evaluating whether a temporary peripheral nerve stimulator can be used to treat chronic migraine.

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About the trial for Nerve Injury

Treatment Groups

This trial involves 2 different treatments. Temporary Peripheral Nerve Stimulator is the primary treatment being studied. Participants will be divided into 2 treatment groups. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Experimental Group 1
Temporary Peripheral Nerve Stimulator
DEVICE
Experimental Group 2
Temporary Peripheral Nerve Stimulator
DEVICE

Eligibility

This trial is for patients born any sex aged 18 and older. There are 3 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Are between 18-65 years old
Have a Sunderland II-V peripheral nerve injury of the upper extremity
Are receiving surgery within 14 days of injury
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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: 6 months
Screening: ~3 weeks
Treatment: Varies
Reporting: 6 months
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 6 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 Temporary Peripheral Nerve Stimulator will improve 4 primary outcomes and 2 secondary outcomes in patients with Nerve Injury. Measurement will happen over the course of Immediately after procedure.

Device Usability Questionnaire
IMMEDIATELY AFTER PROCEDURE
IMMEDIATELY AFTER PROCEDURE
Patient Tolerance to Therapy Questionnaire
IMMEDIATELY AFTER PROCEDURE
IMMEDIATELY AFTER PROCEDURE
Static Two Point Discrimination
6 MONTHS
Measurement of spatial determination
6 MONTHS
Semmes-Weinstein Monofilament Test
6 MONTHS
Measurement of pressure sensitivity
6 MONTHS
DASH Questionnaire
6 MONTHS
Validated questionnaire for functionality in upper extremity injury
6 MONTHS
Safety
6 MONTHS
As measured by the cumulative incidence of adverse events.
6 MONTHS

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 nerve injury?

The most common causes of nerve injury are injury at the point of impact, compression of the nerve by nearby structures, and trauma during surgery. Of these two, the most common nerve lesion is from the impingement of adjacent structures. There are other possible causes of injury but they are much less common. There is also some evidence that nerve growth factors may be involved. At least one factor, the neurotrophic factors, is known or postulated to be the cause of most nerve injuries. The problem is that nobody knows how and why these proteins are associated with nerve damage. If they are in the blood at all, they must be present in very low concentrations.

Anonymous Patient Answer

What are the signs of nerve injury?

Nerves may be affected by many different symptoms, depending on what part of the body the nerve is damaged. Pain is the most common complaint, though it may first appear as numbness or tingling in the hands and feet. The numbness is typically located in the hands, while the tingling is typically in the feet. Other symptoms may include pain, impaired coordination, and loss of appetite.

Anonymous Patient Answer

How many people get nerve injury a year in the United States?

The proportion of adults with nerve injury who require medical or surgical care is not increasing. On the contrary, the proportion of children seen for nerve injury increased between 2002-2005. This suggests that the nerve injury diagnosis could be being underreported, possibly because healthcare providers are not ask[ing]: to the patients if they sustain a nerve injury.

Anonymous Patient Answer

What is nerve injury?

Nerve injury can occur in any part of the body; but is most commonly seen in the legs. Nerve injuries are the most frequent cause of paralysis in adults and children below the age of 10 years, affecting more children than adults to a greater degree. The mechanism of nerve injuries is very complex and many different types of nerve injury have been described.

Anonymous Patient Answer

Can nerve injury be cured?

Theoretically, nerve regeneration can be successful even in the presence of axon trunks that have been irreversibly crushed. However, repair of nerve injuries remains problematic. There is a limitation to the extent to which nerve growth factors and cell transplants can improve the healing of transected nerves. For most axon trunks, nerve regeneration is limited by the distance that axons can grow to before terminating. Therefore, treatment of nerve injuries generally leads to improved function, although functional recovery after such traumatic dislocations is often minimal.

Anonymous Patient Answer

What are common treatments for nerve injury?

Many techniques used for nerve block and nerve repair are common solutions to [pain management](https://www.withpower.com/clinical-trials/pain-management). Neuroplasty, a surgical technique where nerves are reattached to reconstruct the nerve or the muscle, is a new form of treatment. However, this treatment has been used for only a few years and there is no evidence regarding its effectiveness. The use of a peripheral nerve stimulator can cause pain and numbness in the arms or legs, which is typically temporary and disappears over a few days to weeks. Most cases of foot-drop are associated with injury to the peroneal nerve, which innervates portions of the front, back, and lower legs. One study reported that 60% of patients with foot-drop had peroneal nerve injury.

Anonymous Patient Answer

Has temporary peripheral nerve stimulator proven to be more effective than a placebo?

Use of a PNS in the treatment of postoperative pain is safe and effective. Further randomized and controlled clinical studies are needed to determine its long-term results and the optimal clinical applications of this technique.

Anonymous Patient Answer

Does temporary peripheral nerve stimulator improve quality of life for those with nerve injury?

Findings from a recent study demonstrated that temporary use of a peripheral nerve stimulator did not significantly improve QoL for patients with peripheral nerve injury. Thus, temporary stimulation for the relief of symptoms in such patients is unlikely to be cost-effective.

Anonymous Patient Answer

What are the latest developments in temporary peripheral nerve stimulator for therapeutic use?

In the last 13 years new improvements have been made in both the technology and the surgical technique of the peripheral nerve stimulation. New developments are under study to verify the efficacy of the new technologies and technique that are capable of improving the functional recovery of the injured peripheral nerves. In the long term we should be able to solve a chronic problem that has gone on since the early years of nerve stimulation.

Anonymous Patient Answer

What is the latest research for nerve injury?

There is still a need for research focused on nerve repair. Further studies are needed to define different treatments and determine what constitutes a suitable treatment.

Anonymous Patient Answer

What are the common side effects of temporary peripheral nerve stimulator?

Peripheral nerve stimulation with a TENS unit produces few adverse effects on people with peripheral nerve injury. TENS should be considered for all patients who develop PAS for the benefit of pain relief, and the few side effects experienced relate to the temporary nature of the device.

Anonymous Patient Answer

What does temporary peripheral nerve stimulator usually treat?

It takes approximately one month after applying PNMS for the nerve to become inactive because of the natural healing process. PNMS is better than no treatment, and provides temporary and lasting relief. The duration of temporary relief by use of PNMS seems to be a reflection of the healing period of the nerve.

Anonymous Patient Answer
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