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

NCT ID: NCT05935956

Last Updated: 2024-07-11

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 14 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-06-09
• Study Completion Date: 2023-12-21

Brief 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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Magnetic Peripheral Nerve Stimulation

Magnetic Peripheral Nerve Stimulation

Intervention Type: DEVICE

Other Intervention Names

Axon Therapy

Eligibility Criteria

Inclusion Criteria

1. Evidence of a personally signed and dated informed consent indicating that the subject has been informed of all pertinent aspects of the study.

2. Subject is willing and able to comply with scheduled visits, treatment plan, daily pain, and other study procedures subject is able and willing to complete twice daily diary for 90 days.

3. Subject must be literate in English to fill out the study questionnaires.

4. Men or women of any race or ethnicity who are 18-85 years of age.

5. Subject must have chemotherapy induced neuropathy for more than three months per medical history.

6. Subject has a pain score >5 on a VAS at Enrollment/Screening Visit.

7. Subject has completed at least one of the two daily pain diary entries on at least three days between the Enrollment/Screening Visit and Visit 1 with a mean pain score of ≥4 and <10 based on Daily VAS to be eligible for the study.

8. Subject has been on a stable pain medication regimen for at least 28 days, as determined by the investigator or is not taking pain medications, at the baseline assessment in this study.

Exclusion Criteria

1. Subjects with neuropathic pain due to post-herpetic neuropathy, HIV, trigeminal neuralgia, carpal or tarsal tunnel syndrome; subjects whose post-traumatic neuropathic pain is categorized as central (e.g., spinal cord injury) rather than peripheral.

2. Subject has a currently diagnosed progressive neurological disease such as multiple sclerosis, chronic inflammatory demyelinating polyneuropathy, rapidly progressive arachnoiditis, brain or spinal cord tumor, or severe/critical spinal stenosis (stenosis).

3. Subjects with skin conditions in the affected dermatome that in the judgment of the investigator could interfere with evaluation of the neuropathic pain condition.

4. Subjects with other pain that may confound assessment or self-evaluation of the peripheral neuropathic pain.

5. Participation in any other clinical trial within 30 days prior to screening and/or during participation in this study.

6. Any subject considered at risk of suicide or self-harm based on investigator judgment and/or the details of a risk assessment.

7. Other severe acute or chronic medical or psychiatric conditions, or laboratory abnormality, or other factors that may increase the risk associated with study participation or investigational product administration or may interfere with compliance or the interpretation of study results and, in the judgment of the investigator would make the subject inappropriate to participate in the study.

8. Subjects with pending Worker's Compensation, civil litigation, or disability claims; Subjects with fully resolved litigation and compensation claims can participate.

9. Phantom limb pain or pain that feels like it is coming from a body part that is no longer there.

10. Subjects with shrapnel or ferromagnetic objects

11. Subject is currently taking a morphine equivalent daily dose > 120 mg/day.

12. Subject is currently pregnant or is a woman of childbearing potential, not using adequate contraception or not willing to comply with contraception for the duration of the study.

13. Subjects with active drug or alcohol abuse within 1 year prior to screening.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

NeuraLace Medical, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Carrie Johnson, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Carolinas Pain Institute and Center for Clinical Research

Locations

Carolinas Pain Institute and Center for Clinical Research

Winston-Salem, North Carolina, United States

Countries

United States

Other Identifiers

NLM-005

Identifier Type: -

Identifier Source: org_study_id