Electrical Nerve Stimulation for Nerve Injury

(REGAIN Trial)

Recruiting in Palo Alto (17 mi)

+10 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Epineuron Technologies Inc.

Disqualifiers: Peripheral neuropathy, active implanted device

No Placebo Group

Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this trial?

A novel temporary peripheral nerve stimulation system that delivers a single dose of electrical stimulation therapy for 1 hour will be evaluated for safety and effectiveness.

Do I need to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Electrical Nerve Stimulation for Nerve Injury?

Research shows that peripheral nerve stimulation (PNS) is effective in reducing chronic pain from various conditions, including pain after amputation and knee surgery. It works by using electrical signals to block pain messages from reaching the brain, offering a promising non-drug option for managing pain. ^{1 2 3 4 5}

Is electrical nerve stimulation safe for humans?

Peripheral nerve stimulation (PNS) has been used safely since 1965 for treating pain, although some studies note a high rate of hardware-related issues that may require fixing. ^{3 4 6 7 8}

How is the Temporary Peripheral Nerve Stimulation System different from other treatments for nerve injury?

The Temporary Peripheral Nerve Stimulation System is unique because it uses electrical stimulation to target peripheral nerves, helping to block pain signals without the need for surgery or drugs. This noninvasive approach can be used temporarily to assess its effectiveness before considering a permanent implant, making it a flexible option for managing chronic pain from nerve injuries. ^{1 4 8 9 10}

Research Team

Eligibility Criteria

This trial is for individuals who have recently suffered a peripheral nerve injury. It's not suitable for those with ongoing nerve conditions like peripheral neuropathy or anyone with an active implanted device, such as a pacemaker.

Inclusion Criteria

I have a nerve injury in my arms or legs.

Exclusion Criteria

Patients with any active implanted device

I do not have numbness, tingling, or pain in my hands or feet.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single dose of electrical stimulation therapy for 1 hour

1 hour

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Sham Temporary Peripheral Nerve Stimulation System (Procedure)
• Temporary Peripheral Nerve Stimulation System (Electrical Stimulation)

Trial Overview The study is testing the safety and effectiveness of a new temporary nerve stimulation system that delivers electrical therapy for one hour compared to a sham (inactive) version of the same system.

Participant Groups

Group I: Active treatment Experimental Treatment 1 Intervention

Group II: Sham treatment Placebo Group 1 Intervention

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

John Peter Smith Hospital Fort Worth, TX

University of Florida Health Gainesville, FL

Orlando Health Jewett Orthopedic Institute Orlando, FL

The Curtis National Hand Center Baltimore, MD

More Trial Locations

Who Is Running the Clinical Trial?

Epineuron Technologies Inc.

Lead Sponsor

Trials

3

Patients Recruited

160+

Findings from Research

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Uses of percutaneous electrical stimulation of the nervous system. Long, DM.[2011]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Percutaneous Peripheral Nerve Stimulation for the Treatment of Chronic Pain Following Amputation. Cohen, SP., Gilmore, CA., Rauck, RL., et al.[2022]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Peripheral nerve stimulation for saphenous neuralgia. McCullough, M., Kenney, D., Curtin, C., et al.[2023]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mechanism of Action of Temporary Peripheral Nerve Stimulation. Abd-Elsayed, A., Attanti, S., Anderson, M., et al.[2023]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The role of peripheral nerve stimulation in refractory non-operative chronic knee osteoarthritis. Vangeison, CT., Bintrim, DJ., Helms, J., et al.[2023]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term peripheral nerve stimulation for painful nerve injuries. Eisenberg, E., Waisbrod, H., Gerbershagen, HU.[2019]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A technique of distal to proximal revision of peripheral neurostimulator leads: technical note. Mammis, A., Mogilner, AY.[2014]

In a study of patients with chronic neuropathic pain who had previously responded to external noninvasive peripheral nerve stimulation (EN-PNS), all five participants reported continued use of the device and ongoing pain relief after an average of 3.5 years.

Pain intensity significantly decreased from an average of 5.6 to 3.5, and the worst pain reported dropped from 8.6 to 4.8, indicating that EN-PNS can provide long-term benefits for managing chronic pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-Term Treatment of Chronic Neuropathic Pain Using External Noninvasive External Peripheral Nerve Stimulation in Five Patients. Johnson, S., Goebel, A.[2022]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Advancement in Neuromodulation Technology with the Innovation of Design-Specific Peripheral Nerve Stimulators: Sural Nerve Stimulation for Radiculopathy. Langford, B., Mauck, WD.[2021]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

External Noninvasive Peripheral Nerve Stimulation Treatment of Neuropathic Pain: A Prospective Audit. Johnson, S., Ayling, H., Sharma, M., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Uses of percutaneous electrical stimulation of the nervous system. [2011]

2. England pubmed.ncbi.nlm.nih.gov

Percutaneous Peripheral Nerve Stimulation for the Treatment of Chronic Pain Following Amputation. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Peripheral nerve stimulation for saphenous neuralgia. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Mechanism of Action of Temporary Peripheral Nerve Stimulation. [2023]

5. England pubmed.ncbi.nlm.nih.gov

The role of peripheral nerve stimulation in refractory non-operative chronic knee osteoarthritis. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Long-term peripheral nerve stimulation for painful nerve injuries. [2019]

7. Switzerland pubmed.ncbi.nlm.nih.gov

A technique of distal to proximal revision of peripheral neurostimulator leads: technical note. [2014]

8. United States pubmed.ncbi.nlm.nih.gov

Long-Term Treatment of Chronic Neuropathic Pain Using External Noninvasive External Peripheral Nerve Stimulation in Five Patients. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Advancement in Neuromodulation Technology with the Innovation of Design-Specific Peripheral Nerve Stimulators: Sural Nerve Stimulation for Radiculopathy. [2021]

10. United States pubmed.ncbi.nlm.nih.gov

External Noninvasive Peripheral Nerve Stimulation Treatment of Neuropathic Pain: A Prospective Audit. [2022]