Safety and Effectiveness of Magnetic Peripheral Nerve Stimulation for the Treatment of Chemotherapy Induced Neuropathy — mPNS-CH  

Neuropathic Pain Clinical Trial

Official title: An Observational, Single Arm, Open Label Study Evaluating the Safety and Effectiveness of Magnetic Peripheral Nerve Stimulation (mPNS) for the Treatment of Chemotherapy Induced Neuropathy (mPNS-CH)

Status Recruiting

Clinical Trial Summary

Assess the safety and effectiveness of Axon Therapy in the treatment of chemotherapy-induced neuropathy

Clinical Trial Description

This is an observational, single arm, open label study in which up to 20 subjects diagnosed with chemotherapy induced neuropathy will be treated with mPNS.

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 and start their treatment.

All subjects will return to the clinic for follow-up assessment at Day 30 (± 14 days) and Day 90 (± 14 days) and will return to the clinic for mPNS 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

• Month 3: Treatments every 2-4 weeks

• Additional treatments to treat flare ups; defined as an episode of pain with a VAS of at least 5 following an increase in daily activities.

• The Lead Investigator is provided the discretion to modify the treatment protocol based on subject response.

In addition to in-clinic assessments and treatments, all subjects will complete an electronic twice daily diary through 90 days of the study. Subjects will receive weekly phone follow-up for diary reminders and to assess for the 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

• Chemotherapy-induced Peripheral Neuropathy
• Neuralgia
• Neuropathic Pain
• Peripheral Nervous System Diseases

• NCT number: NCT05935956
• Study type: Observational
• Source: NeuraLace Medical, Inc.
• Contact: Joe Milkovits
• Phone: (858) 229-9218
• Email: joe@neuralacemedical.com
• Status: Recruiting
• Start date: June 9, 2023
• Completion date: November 2023