Axon Therapy for Neuropathic Pain

Recruiting in Palo Alto (17 mi)

+3 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: NeuraLace Medical, Inc.

No Placebo Group

Trial Summary

What is the purpose of this trial?

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

Research Team

Joe Milkovits

Principal Investigator

NeuraLace Medical

Eligibility Criteria

Adults aged 18-75 with chronic pain from nerve damage due to trauma or surgery, who can follow the study plan and fill out English questionnaires. They must have stable pain levels and not be involved in certain legal claims or other trials. Excluded are those with specific medical conditions, high daily doses of opioids, or at risk for suicide.

Inclusion Criteria

I am willing and able to follow the study's schedule and keep a twice-daily diary.

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

Your doctor has identified and written down which nerves are affected by your condition in your medical records.

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Exclusion Criteria

I have nerve pain from shingles, HIV, facial nerve issues, wrist nerve issues, or a spinal cord injury.

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

I have a skin condition that might affect pain assessment.

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Treatment Details

Interventions

Axon Therapy (Transcutaneous Magnetic Stimulation)

Trial OverviewThe trial is testing Axon Therapy using transcutaneous magnetic stimulation (tMS) versus standard pain management methods for treating long-lasting neuropathic pain caused by injury or surgery.

Participant Groups

2Treatment groups

Experimental Treatment

Active Control

Group I: CMM + Axon TherapyExperimental Treatment1 Intervention

Participants will return to the clinic for assessment at Day 30 (± 14 days), Day 90 (± 14 days), Day 180 (± 30 days) and Day 365 (± 30 days). Participants randomized to 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-monthly treatment * Months 3-12: Treatments every 2-4 weeks In addition to in-clinic assessments and treatments, all participants will a 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 participant is not in clinic for treatment.

Group II: CMM OnlyActive Control1 Intervention

Participants will return to the clinic for assessment at Day 30 (± 14 days), Day 90 (± 14 days), Day 180 (± 30 days) and Day 365 (± 30 days)