Axon Therapy for Post-Traumatic Peripheral Neuropathic Pain Compared to Conventional Medical Management
- Conditions
- Neuropathic PainPeripheral Neuropathy
- Interventions
- Device: CMM + Axon Therapy
- Registration Number
- NCT04795635
- Lead Sponsor
- NeuraLace Medical, Inc.
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 61
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description CMM + Axon Therapy CMM + Axon Therapy 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.
- Primary Outcome Measures
Name Time Method Comparison of the Proportion of Responders 90 days 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.
- Secondary Outcome Measures
Name Time Method Depression Anxiety Stress Scales (DASS) 90 days The secondary endpoints of this trial are between group comparisons b
Patient Global Impression of Change (PGIC) 90 days The secondary endpoints of this trial are between group comparisons
Visual Analog Scale (VAS) for Pain 30 and 90 days Scores from daily diaries at 30 and 90 days (analysis will include a comparison of compliance across treatment groups)
Brief Pain (BPI Inventory 90 days The secondary endpoints of this trial are between group comparisons
Daily Sleep Interference Scale (DSIS) 30 and 90 days The secondary endpoints of this trial are between group comparisons
5D-5D-3L 90 days The secondary endpoints of this trial are between group comparisons
Pain Disability Index (PDI) 90 days The secondary endpoints of this trial are between group comparisons
Trial Locations
- Locations (3)
National Spine and Pain Centers
🇺🇸Shrewsbury, New Jersey, United States
SC Pain and Spine Specialists (Crescent Moon Research Corp)
🇺🇸Murrells Inlet, South Carolina, United States
Carolinas Pain Institute
🇺🇸Winston-Salem, North Carolina, United States