Axon Therapy for Post-Traumatic Peripheral Neuropathic Pain Compared to Conventional Medical Management

Neuropathic Pain Clinical Trial

Official title: A Prospective, Randomized, Clinical Trial Comparing the Safety and Effectiveness of Axon Therapy for Post-Traumatic Peripheral Neuropathic Pain (PTPNP) to Conventional Medical Management (CMM)

Status Active, not recruiting

Clinical Trial Summary

Compare Axon Therapy using transcutaneous magnetic stimulation (tMS) against conventional medical management in treating post-traumatic peripheral neuropathic pain (PTPNP).

Clinical Trial Description

Subjects will be consented, screened, and undergo a 7-day baseline assessment to measure pain scores and assess diary compliance. Subjects who meet inclusion criteria will undergo an in-clinic baseline evaluation, receive randomization assignment, and start their respective treatments.

Those randomized to the CMM plus Axon Therapy group will receive their first Axon Therapy treatment and then have a follow-up phone call after 24 hours to assess if the patient is a candidate for Axon Therapy, that is if the subject is neuropathic or nociceptive. Those that are not candidates for Axon Therapy will be monitored for 30 days for AEs and then they will exit the study as screen failures. Screen failures will not count against enrollment numbers.

All subjects will return to the clinic for follow-up assessment at Day 30 (± 14 days), Day 90 (± 14 days), Day 180 (± 14 days) and Day 365 (± 30 days) and if in the CMM plus Axon Therapy group will return to the clinic for Axon Therapy treatments as follows:

• Month 1: 6 treatments

• WEEK 1: 3 treatments (consecutive treatments are best)

• WEEK 2-4: Weekly treatments

• Month 2: Bi-Weekly treatment

• Months 3-12: Treatments every 2-4 weeks

• Additional treatments to treat flare ups; defined as an episode of pain with a VAS >greater or equal to 6 following an increase in daily activities.

At day 90 (± 15 days), subjects will be allowed to crossover to the alternative treatment group. Subjects who crossover from CMM to CMM plus Axon Therapy will follow the CMM plus Axon Therapy regimen, remaining in the study for 15 months. These subjects will have follow-up visits at Day 120 (± 14 days), Day 180 (± 14 days) ,Day 270 (± 14 days), and Day 450 (± 30 days).

Subjects who crossover from CMM plus Axon Therapy to CMM will be monitored for 30 days for AEs and then they will exit the study. The reason for ending therapy will be recorded.

In addition to in-clinic assessments and treatments, all subjects will complete an electronic daily diary up to twice daily throughout the first 90 days and for crossover subjects they will complete 90 days of Axon treatment therapy and up to Day 180. They will receive weekly phone follow-up to assess pain intensity and occurrence of adverse events after treatment starts. Weekly phone follow-ups will only occur during weeks when the subject is not seen in the clinic. ;

Related Conditions & MeSH terms

• Neuralgia
• Neuropathic Pain
• Peripheral Nervous System Diseases
• Peripheral Neuropathy

• NCT number: NCT04795635
• Study type: Interventional
• Source: NeuraLace Medical, Inc.
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 14, 2021
• Completion date: March 22, 2024