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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 belowSelect...
I have recorded my pain levels as between 4 and 10 on most days since my screening.
Select...
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:Select...
I have nerve pain from shingles, HIV, facial nerve issues, wrist nerve issues, or a spinal cord injury.
Select...
I am taking more than 120 mg of pain medication daily.
Select...
I haven't had cancer, except for skin or early cervical cancer, in the last 5 years.
Select...
I have a progressive neurological disease like MS or severe spinal issues.
Select...
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
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 moreOther 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 moreAwards & 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)
Find a Location
Who is running the clinical trial?
NeuraLace Medical, Inc.Lead Sponsor
2 Previous Clinical Trials
107 Total Patients Enrolled
Monica KelloggStudy DirectorNeuraLace Medical
Joe MilkovitsStudy DirectorNeuraLace Medical
1 Previous Clinical Trials
93 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have nerve pain from shingles, HIV, facial nerve issues, wrist nerve issues, or a spinal cord injury.I am willing and able to follow the study's schedule and keep a twice-daily diary.Your doctor has identified and written down which nerves are affected by your condition in your medical records.I have recorded my pain levels as between 4 and 10 on most days since my screening.My pain medication has not changed in the last 28 days.I have a skin condition that might affect pain assessment.You have already tried another implantable device for the same medical issue and it did not work.I am taking more than 120 mg of pain medication daily.I have had nerve pain for over three months due to an injury or surgery.I haven't had cancer, except for skin or early cervical cancer, in the last 5 years.I am between 18 and 75 years old.I have logged my pain levels, averaging between 4 and 10, on most days between my first and second visits.I have a progressive neurological disease like MS or severe spinal issues.You have metal fragments or objects in your body.You are at risk of hurting yourself, based on the researcher's judgment or a risk assessment.If you have a pacemaker, defibrillator, or insulin pump close to where you feel pain, you cannot participate. But if the device is farther away, you can still join the study.You have a pain score of 6 or higher at the time of screening.I experience pain from a limb that has been amputated.I am willing and able to follow the study's schedule and keep a twice-daily diary.My doctor has identified and recorded the specific nerve(s) affected by my condition.I do not have other pain that could affect my ability to assess my nerve pain.You must be literate in English to fill out the study questionnaires.My pain medication has not changed in the last 28 days, or I am not on any.
Research Study Groups:
This trial has the following groups:- Group 1: CMM Only
- Group 2: CMM + Axon Therapy
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Peripheral Neuropathy Patient Testimony for trial: Trial Name: NCT04795635 — N/A
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