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Transcutaneous Magnetic Stimulation

Axon Therapy for Neuropathic Pain

N/A

Waitlist Available

Research Sponsored by NeuraLace Medical, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Subject must have their implicated peripheral nerve(s) identified and documented in their medical record

Must not have

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

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 180 and 365

Awards & highlights

No Placebo-Only Group

Summary

This trial will compare the effectiveness of Axon Therapy, using transcutaneous magnetic stimulation (tMS), against conventional medical management in treating post-traumatic peripheral neuropathic pain (PTPNP).

Who is the study for?

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.

What is being tested?

The 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.

What are the potential side effects?

While the side effects of Axon Therapy aren't detailed here, similar treatments may cause skin irritation at the treatment site, headache, dizziness, or temporary worsening of pain symptoms.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have recorded my pain levels as between 4 and 10 on most days since my screening.

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My doctor has identified and recorded the specific nerve(s) affected by my condition.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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I am taking more than 120 mg of pain medication daily.

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I haven't had cancer, except for skin or early cervical cancer, in the last 5 years.

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I have a progressive neurological disease like MS or severe spinal issues.

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I experience pain from a limb that has been amputated.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 180 and 365

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 180 and 365

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 180 and 365 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Comparison of the Proportion of Responders

Secondary study objectives

5D-5D-3L

Brief Pain (BPI Inventory

Daily Sleep Interference Scale (DSIS)

+4 more

Other study objectives

Improvement in PDI score

Mean/percent reduction in morphine equivalent daily dose (MEDD)

Proportion of subjects in each satisfaction category at Day 180 and 365 (Subjects on Axon Therapy).

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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)

0 / 7Eligibility criteria met