Clinical trial NCT04795635: Axon Therapy for Post-Traumatic Peripheral Neuropathic Pain Compared to Conventional Medical Management
Official title: A Prospective, Randomized, Clinical Trial Comparing the Safety and Effectiveness of Axon Therapy for Post-Traumatic Peripheral Neuropathic Pain (PTPNP) to Conventional Medical Management (CMM)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Neuropathic Pain
Peripheral Neuropathy
Keywords: transcutaneous magnetic stimulation
axon therapy
post-traumatic peripheral neuropathic pain
Lead sponsor: NeuraLace Medical, Inc.
Sponsor class: INDUSTRY
First posted: 2021-03-12
Enrollment: 61
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: 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)
Primary purpose: TREATMENT

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

Detailed description: 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, receive randomization assignment, and start their respective treatments.

Those randomized to the CMM plus Axon Therapy group will receive their first Axon Therapy treatment and then have a follow-up phone call after 24 hours to assess if the patient is a candidate for Axon Therapy, that is if the subject is neuropathic or nociceptive. Those that are not candidates for Axon Therapy will be monitored for 30 days for AEs and then they will exit the study as screen failures. Screen failures will not count against enrollment numbers.

All subjects will return to the clinic for follow-up assessment at Day 30 (± 14 days), Day 90 (± 14 days), Day 180 (± 14 days) and Day 365 (± 30 days) and if in 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-Weekly treatment
* Months 3-12: Treatments every 2-4 weeks
* Additional treatments to treat flare ups; defined as an episode of pain with a VAS \>greater or equal to 6 following an increase in daily activities.

At day 90 (± 15 days), subjects will be allowed to crossover to the alternative treatment group. Subjects who crossover from CMM to CMM plus Axon Therapy will follow the CMM plus Axon Therapy regimen, remaining in the study for 15 months. These subjects will have follow-up visits at Day 120 (± 14 days), Day 180 (± 14 days) ,Day 270 (± 14 days), and Day 450 (± 30 days).

Subjects who crossover from CMM plus Axon Therapy to CMM will be monitored for 30 days for AEs and then they will exit the study. The reason for ending therapy will be recorded.

In addition to in-clinic assessments and treatments, all subjects will complete an electronic daily diary up to twice daily throughout the first 90 days and for crossover subjects they will complete 90 days of Axon treatment therapy and up to Day 180. They will 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 subject is not seen in the clinic.

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.
3. Subject must be literate in English to fill out the study questionnaires.
4. Men or women of any race or ethnicity who are 18-75 years of age.
5. 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).
6. Subject has a score ≥6 on 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 Randomization Visit (Visit 1) with a mean pain score of ≥4 and ≤10 based on Daily VAS to be eligible for randomization.
8. 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.
9. Subject must have their implicated peripheral nerve(s) identified and documented in their medical record.

Exclusion Criteria

1. 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.
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; subjects with significant somatic pain at the site of their trauma that may confound assessment or self-evaluation of their neuropathic pain.
5. Participation in any other clinical trial within the 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, 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.
9. 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.
10. 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).
11. Phantom limb pain or pain that feels like it is coming from a body part that is no longer there.
12. Subjects who have failed other neuromodulation implantable device for the same indication
13. Subjects with shrapnel or ferromagnetic objects
14. Subject is currently taking a morphine equivalent daily dose \> 120 mg/day.
15. 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.

Primary outcomes:
measure: Comparison of the Proportion of Responders
timeFrame: 90 days
Secondary outcomes:
measure: Visual Analog Scale (VAS) for Pain
timeFrame: 30 and 90 days
measure: Brief Pain (BPI Inventory
timeFrame: 90 days
measure: Daily Sleep Interference Scale (DSIS)
timeFrame: 30 and 90 days
measure: 5D-5D-3L
timeFrame: 90 days
measure: Patient Global Impression of Change (PGIC)
timeFrame: 90 days
measure: Depression Anxiety Stress Scales (DASS)
timeFrame: 90 days
measure: Pain Disability Index (PDI)
timeFrame: 90 days
Other outcomes:
measure: Reduction or elimination non-opioid pain medications
timeFrame: 365 Days
measure: Improvement in PDI score
timeFrame: 365 Days
measure: Mean/percent reduction in morphine equivalent daily dose (MEDD)
timeFrame: Day 180 and 365
measure: Proportion of subjects who discontinue treatment and/or change treatment arms
timeFrame: Day 90
measure: Proportion of subjects in each satisfaction category at Day 180 and 365 (Subjects on Axon Therapy).
timeFrame: Day 180 and Day 365
Locations:
city: Shrewsbury
country: United States
facility: National Spine and Pain Centers
state: New Jersey
city: Winston-Salem
country: United States
facility: Carolinas Pain Institute
state: North Carolina
city: Murrells Inlet
country: United States
facility: SC Pain and Spine Specialists (Crescent Moon Research Corp)
state: South Carolina
Study officials:
affiliation: NeuraLace Medical
name: Joe Milkovits
role: STUDY_DIRECTOR
References: