Neuropathic PainNCT04795635
Axon Therapy for Post-Traumatic Peripheral Neuropathic Pain Compared to Conventional Medical Management
A study testing CMM + Axon Therapy in people with Neuropathic Pain and Peripheral Neuropathy, run by NeuraLace Medical, Inc. at 3 sites in United States.
Trial summary
Compare Axon Therapy using transcutaneous magnetic stimulation (tMS) against conventional medical management in treating post-traumatic peripheral neuropathic pain (PTPNP). Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Neuropathic Pain, Peripheral Neuropathy
- What is being tested?
- CMM + Axon Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 3 sitesUnited States
- Study dates
- 14 Apr 2021to 22 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
SC Pain and Spine Specialists (Crescent Moon Research Corp)
Murrells Inlet, South Carolina, 29576
National Spine and Pain Centers
Shrewsbury, New Jersey, 07702
Carolinas Pain Institute
Winston-Salem, North Carolina, 27103
About this study
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)
Compare Axon Therapy using transcutaneous magnetic stimulation (tMS) against conventional medical management in treating post-traumatic peripheral neuropathic pain (PTPNP).
Read the 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.
- Conditions
- Neuropathic Pain, Peripheral Neuropathy
- Being tested
- CMM + Axon Therapy
- Keywords
- transcutaneous magnetic stimulation, axon therapy, post-traumatic peripheral neuropathic pain
- Medical subject headings
- Neuralgia, Peripheral Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CMM + Axon TherapyDevice
transcutaneous magnetic stimulation (tMS)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 90 days
Secondary outcomes (7)
Visual Analog Scale (VAS) for Pain
Scores from daily diaries at 30 and 90 days (analysis will include a comparison of compliance across treatment groups)
Measured: 30 and 90 days
Brief Pain (BPI Inventory
The secondary endpoints of this trial are between group comparisons
Measured: 90 days
Daily Sleep Interference Scale (DSIS)
The secondary endpoints of this trial are between group comparisons
Measured: 30 and 90 days
5D-5D-3L
The secondary endpoints of this trial are between group comparisons
Measured: 90 days
Patient Global Impression of Change (PGIC)
The secondary endpoints of this trial are between group comparisons
Measured: 90 days
Depression Anxiety Stress Scales (DASS)
The secondary endpoints of this trial are between group comparisons b
Measured: 90 days
Pain Disability Index (PDI)
The secondary endpoints of this trial are between group comparisons
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2021
- Study start14 Apr 2021
- Primary completion22 May 2024
- Study completion22 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Neuropathic PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- 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)
- Masking
- None (open label)
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- NeuraLace Medical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Joe Milkovits, Study director, NeuraLace Medical
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04795635
- Sponsor's protocol ID
- NLM-001
- Status last verified
- Jul 2024
- First submitted
- 9 Mar 2021
- Last updated
- 12 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 40918409
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT04795635
- Acronym / sponsor ID
- NLM-001
- Conditions
- Neuropathic Pain, Peripheral Neuropathy
- Keywords
- transcutaneous magnetic stimulation, axon therapy, post-traumatic peripheral neuropathic pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 61 participants (actual)
- Lead sponsor
- NeuraLace Medical, Inc.Industry (pharma, biotech, devices)
- Study start
- 14 Apr 2021 (actual)
- Primary completion
- 22 May 2024 (actual)
- Study completion
- 22 Aug 2024 (estimated)
- First posted
- 12 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- 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)
| Arm | Type | Receives |
|---|---|---|
| CMM + Axon Therapy | Experimental | Device: CMM + Axon TherapyParticipants 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. |
| 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) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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).
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CMM + Axon Therapytranscutaneous magnetic stimulation (tMS) | Device | CMM + Axon Therapy |
Primary outcome
Comparison of the Proportion of Responders
Time frame: 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.
7 secondary outcomes
Visual Analog Scale (VAS) for Pain
Time frame: 30 and 90 days
Brief Pain (BPI Inventory
Time frame: 90 days
Daily Sleep Interference Scale (DSIS)
Time frame: 30 and 90 days
5D-5D-3L
Time frame: 90 days
Patient Global Impression of Change (PGIC)
Time frame: 90 days
Depression Anxiety Stress Scales (DASS)
Time frame: 90 days
Pain Disability Index (PDI)
Time frame: 90 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2024.
- Derived from this study: PubMed 40918409Kapural 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joe Milkovits study director
NeuraLace Medical
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CMM + Axon Therapy in people with Neuropathic Pain and Peripheral Neuropathy, run by NeuraLace Medical, Inc. at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of the Proportion of Responders (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04795635, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2024; AzTrials last refreshed its copy on 26 Oct 2026.