NCT05935956

Safety and Effectiveness of Magnetic Peripheral Nerve Stimulation for the Treatment of Chemotherapy Induced Neuropathy

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: Completed
• Phase: —
• Study type: Observational
• Enrollment: 14 (actual)
• Sponsor: NeuraLace Medical, Inc. · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• Neuralgia
• Neuropathic Pain
• Chemotherapy-induced Peripheral Neuropathy

Interventions

Type	Name	Description
DEVICE	Magnetic Peripheral Nerve Stimulation	Magnetic Peripheral Nerve Stimulation

Timeline

• Start date: 2023-06-09
• Primary completion: 2023-12-21
• Completion: 2023-12-21
• First posted: 2023-07-07
• Last updated: 2024-07-11

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study