Axon Therapy for Post-Traumatic Peripheral Neuropathic Pain Compared to Conventional Medical Management

NCT04795635 | Active Not Recruiting FDA Device

• 1 other identifier: NLM-001
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

Neuropathic Pain; Peripheral Neuropathy

Keywords

transcutaneous magnetic stimulation; axon therapy; post-traumatic peripheral neuropathic pain

Outcome Measures

Primary Outcomes (1)

• Comparison of the Proportion of Responders

  The primary effectiveness endpoint is a between groups comparison of the proportion of responders, defined as a subject who experiences 50% or greater reduction from baseline in neuropathic pain intensity as measured by in-clinic visual analog score (VAS) for primary area of pain at Day 90 with no increase in baseline pain medications within 4 weeks of the Day 90 visit.

  90 days

Secondary Outcomes (7)

• Visual Analog Scale (VAS) for Pain

  30 and 90 days

• Brief Pain (BPI Inventory

  90 days

• Daily Sleep Interference Scale (DSIS)

  30 and 90 days

• 5D-5D-3L

  90 days

• Patient Global Impression of Change (PGIC)

  90 days

Other Outcomes (5)

• Reduction or elimination non-opioid pain medications

  365 Days

• Improvement in PDI score

  365 Days

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

  Day 180 and 365

Study Arms (2)

CMM + Axon Therapy

EXPERIMENTAL

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.

Device: CMM + Axon Therapy

CMM Only

NO 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)

Interventions

CMM + Axon Therapy DEVICE

transcutaneous magnetic stimulation (tMS)

CMM + Axon Therapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Evidence of a personally signed and dated informed consent indicating that the subject has been informed of all pertinent aspects of the study.
• 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.
• Subject must be literate in English to fill out the study questionnaires.
• Men or women of any race or ethnicity who are 18-75 years of age.
• Subject must have chronic peripheral neuropathic pain present for more than three months after a traumatic or surgical event per medical history (this may include, for example, motor vehicle accident, fall, sports injury, knee or hip replacement, hernia repair, thoracotomy, mastectomy, focal/localized burns, or crush injury).
• Subject has a score ≥6 on VAS at Enrollment/Screening Visit.
• 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 has been on a stable pain medication regimen for at least 28 days or is not taking pain medications, as determined by the investigator, at the baseline assessment in this study.
• Subject must have their implicated peripheral nerve(s) identified and documented in their medical record.

You may not qualify if:

• 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 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).
• Subjects with skin conditions in the affected dermatome that in the judgment of the investigator could interfere with evaluation of the neuropathic pain condition.
• Subjects with other pain that may confound assessment or self-evaluation of the peripheral neuropathic pain; subjects with significant somatic pain at the site of their trauma that may confound assessment or self-evaluation of their neuropathic pain.
• Participation in any other clinical trial within the 30 days prior to screening and/or during participation in this study.
• Any subject considered at risk of suicide or self-harm based on investigator judgment and/or the details of a risk assessment.
• 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.
• Subjects with pending Worker's Compensation, Worker's Compensation, civil litigation, or disability claims pertinent to the subject based upon trauma; current involvement in out-of-court settlements for claims pertinent to subject's trauma; Subjects with fully resolved litigation and compensation claims can participate.
• Subjects who have had a diagnosis of malignancy other than basal cell carcinoma, or carcinoma in situ of the cervix within the past five years, to include life expectancy less than 1 year due to advanced malignancy.
• Subjects with implantable "electrical" medical devices such as a cardiac pacemaker, defibrillator, or insulin pump within four (4) inches or less of the site of pain to be treated by Axon Therapy. (Subject with an implantable device greater than four (4) inches from the site of pain to be treated should NOT be excluded).
• Phantom limb pain or pain that feels like it is coming from a body part that is no longer there.
• Subjects who have failed other neuromodulation implantable device for the same indication
• Subjects with shrapnel or ferromagnetic objects
• Subject is currently taking a morphine equivalent daily dose \> 120 mg/day.
• Subject is a woman of childbearing potential, not using adequate contraception as per investigator judgment or not willing to comply with contraception for the duration of the study.

Sponsors & Collaborators

• NeuraLace Medical, Inc.: lead

Study Sites (3)

National Spine and Pain Centers

Shrewsbury, New Jersey, 07702, United States

Location

Carolinas Pain Institute

Winston-Salem, North Carolina, 27103, United States

Location

SC Pain and Spine Specialists (Crescent Moon Research Corp)

Murrells Inlet, South Carolina, 29576, United States

Location

Related Publications (1)

• Kapural L, Patel J, Rosenberg JC, Li S, Amirdelfan K, Bedder M. Efficacy and Safety of Magnetic Peripheral Nerve Stimulation for Treatment of Neuropathic Pain; One Year Follow Up of Long-Term Outcomes. J Pain Res. 2025 Aug 30;18:4471-4481. doi: 10.2147/JPR.S538263. eCollection 2025.

  PMID: 40918409 DERIVED

MeSH Terms

Conditions

Neuralgia; Peripheral Nervous System Diseases

Condition Hierarchy (Ancestors)

Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Joe Milkovits

  NeuraLace Medical

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is a prospective, randomized, controlled, multi-center, clinical trial in which 80 participants diagnosed with PTPNP will be randomized 1:1 into one of two treatment groups: 1. CMM plus Axon Therapy (n=64) 2. CMM alone (n=64)

Study Record Dates

• First Submitted: March 9, 2021
• First Posted: March 12, 2021
• Study Start: April 14, 2021
• Primary Completion: May 22, 2024
• Study Completion: August 22, 2024
• Last Updated: July 12, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)