NeuralgiaNCT05620225
Axon Therapy and Conventional Medical Management for Painful Diabetic Neuropathy Compared to Sham and Conventional Medical Management
A study testing Axon Therapy and CMM in people with Neuralgia and Neuropathic Pain, run by NeuraLace Medical, Inc. at 7 sites in United States.
Trial summary
Compare Axon Therapy plus conventional medical management (CMM) to Sham plus CMM in reducing neuropathic pain in patients with painful diabetic neuropathy (PDM). Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Neuralgia, Neuropathic Pain, Painful Diabetic Neuropathy
- What is being tested?
- Axon Therapy and CMM
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 93 participants
- Where
- 7 sitesUnited States
- Study dates
- 15 Dec 2022to 22 Nov 2023
- 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 85 years
- All sexes
- No healthy volunteers
- 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 electronic diary for up to 60 days.
- Subject must be literate in English to fill out the study questionnaires.
- Men or women of any race or ethnicity who are 18-85 years of age.
- Subjects must not have a Body Mass Index >40.
- Subject must have painful diabetic neuropathy (Type 2) present in the lower limbs for more than three months per medical history
Show all 9Show fewer
- Subject has a pain score ≥5 on VAS at Enrollment/Screening Visit.
- Subject has completed at least one of the two daily pain diary entries on at least five days between the Enrollment/Screening Visit and Visit 1 with a mean pain score of ≥4 and <10 based on Daily VAS to be eligible for the study.
- Subject is on a stable pain medication regimen or is not taking pain medications, as
Who cannot join
- Subjects with neuropathic pain due to post-herpetic neuropathy, HIV, trigeminal neuralgia; subjects whose post- traumatic neuropathic pain is categorized as central (e.g., spinal cord injury) rather than peripheral.
- Subjects with any other chronic or recurrent pain syndrome rated greater than "mild" on a mild-moderate-severe scale, or which the investigator judges may interfere with the patients ability to report their pain accurately.
- Any disorder that may be confused with PDN, such as tarsal tunnel syndrome, sciatica, bunions, ischemic claudication or arthritis of the feet or ankles.
- 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.
Show all 19Show fewer
- 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.
- 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. 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 or not willing to comply with contraception for the duration of the study.
- Subjects with active drug or alcohol abuse within 1 year prior to screening.
- Subjects with hemoglobin A1C of 9% or higher for 90 days prior to screening.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Centurion Spine and Pain Centers
Brunswick, Georgia, 31520
SC Pain and Spine Specialists, LLC
Murrells Inlet, South Carolina, 29576
Florida Pain Management Associates, P.A.
Sebastian, Florida, 32958
Truwell Health
St. Petersburg, Florida, 33701
Florida Pain Management Associates, P.A.
Vero Beach, Florida, 32960
Centurion Spine and Pain Centers
Waycross, Georgia, 31501
Carolinas Pain Institute and Center for Clinical Research
Winston-Salem, North Carolina, 27103
About this study
Official title: A Multicenter, Randomized, Clinical Trial Comparing the Safety and Effectiveness of Axon Therapy and Conventional Medical Management (AT+CMM) for the Treatment of Painful Diabetic Neuropathy to Sham and Conventional Medical Management (Sham+CMM)
Compare Axon Therapy plus conventional medical management (CMM) to Sham plus CMM in reducing neuropathic pain in patients with painful diabetic neuropathy (PDM).
Read the detailed description
This is a two-phase study.
Phase 1 is a double blinded, two-arm, randomized, multi-center clinical trial to assess 1-month efficacy as compared to a sham group. Up to approximately 80 subjects diagnosed with painful diabetic neuropathy will be randomized 3:1 into one of two treatment groups:
- Axon Therapy plus CMM (AT+CMM)
- Sham plus CMM (Sham+CMM)
Subjects will be consented, screened, and then undergo a 7-day baseline assessment period. Subjects will be asked to record pain, numbness, and sleep scores via a twice daily electronic diary. Subjects who meet inclusion criteria, including diary compliance, will undergo an in-clinic baseline evaluation (Day 1), be randomized, and start their treatments.
All subjects will return to the clinic for treatments as follows:
● Day 1 - 30: 6 treatments
- Week 1: 3 treatments
- Week 2-4: Weekly treatments
All subjects will return to the clinic for follow-up assessment at Day 30 (± 5 days). At the Day 30 visits subjects will be asked if they want to participate in Phase 2 of the study.
Phase 2 of the study is an unblinded, one-arm, multi-center trial to assess extended efficacy of the treatment. At Day 30, subjects will be unblinded and allowed to remain in the study for an additional 60 (AT+CMM) to 90 (ATx+CMM) days. Those in the Sham arm can choose to crossover to active treatment ( ATx+CMM).
Subjects in the AT+CMM arm will return to the clinic as follows:
- Month 2: Bi-weekly treatment
- Month 3: Treatments every 2-4 weeks
- Additional treatments to treat flare ups; defined as an episode of pain with a VAS 6.
Subjects in the ATx+CMM arm will return to the clinic as follows:
- Month 2: 6 treatments
- Week 1: 3 treatments
- Week 2-4: Weekly treatments
- Month 3: Bi-weekly treatment
- Month 4: Treatments every 2-4 weeks
- Additional treatments to treat flare ups; defined as an episode of pain with a VAS 6.
Subjects who do not choose to remain in the study will be monitored for 30 days for AEs and then they will exit the study. The subject's reason for exiting the study will be recorded.
In addition to in-clinic assessments and treatments, all subjects will complete an electronic twice daily diary through Day 30 of the study (Day 60 for ATx+CMM subjects). Subjects will receive weekly phone follow-up for diary reminders and to assess for the occurrence of adverse events. Weekly phone follow-up will occur only during weeks when the subject is not seen in the clinic.
- Conditions
- Neuralgia, Neuropathic Pain, Painful Diabetic Neuropathy
- Being tested
- Axon Therapy and CMM, Sham and CMM
- Keywords
- transcutaneous magnetic stimulation, axon therapy, peripheral neuropathic pain, diabetic neuropathy
- Medical subject headings
- Neuralgia, Diabetic Neuropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Axon Therapy and CMMDevice
transcutaneous magnetic stimulation (TMS)
Sham and CMMDevice
Sham and CMM
| Study group | Role | What they receive |
|---|---|---|
| Axon Therapy + CMM | Experimental | Subjects will be consented, screened, and then undergo a 7-day baseline assessment period. Subjects will be asked to record pain, numbness, and sleep scores via a twice daily electronic diary. Subjects who meet inclusion criteria, including diary compliance, will undergo an in-clinic baseline evaluation (Day 1), be randomized, and start their treatments.
All subjects will return to the clinic for treatments as follows:
● Day 1 - 30: 6 treatments
* Week 1: 3 treatments
* Week 2-4: Weekly treatments
All subjects will return to the clinic for follow-up assessment at Day 30 (± 5 days). At the Day 30 visits subjects will be asked if they want to participate in Phase 2 of the study. Receives: Device: Axon Therapy and CMM |
| Sham + CMM | Sham comparator | Subjects will be consented, screened, and then undergo a 7-day baseline assessment period. Subjects will be asked to record pain, numbness, and sleep scores via a twice daily electronic diary. Subjects who meet inclusion criteria, including diary compliance, will undergo an in-clinic baseline evaluation (Day 1), be randomized, and start their treatments.
All subjects will return to the clinic for treatments as follows:
● Day 1 - 30: 6 treatments
* Week 1: 3 treatments
* Week 2-4: Weekly treatments
All subjects will return to the clinic for follow-up assessment at Day 30 (± 5 days). At the Day 30 visits subjects will be asked if they want to participate in Phase 2 of the study. Receives: Device: Sham and CMM |
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 efficacy endpoint is a between groups comparison of pain change from baseline to 30 days.
Measured: 30 days
Comparison of therapy-related AEs between the 2 Study arms
The primary safety endpoint for this study is a comparison of therapy-related AEs through Day 30 between the 2 arms of the Study.
Measured: 30 days
Secondary outcomes (13)
Visual Analog Scale (VAS) for Pain
Scores from daily diaries will be compared to baseline overall and by group (Axon therapy (AT) plus CMM and AT crossover (ATx) plus CMM)
Measured: 30- and 90-days post-treatment
VAS for Numbness
Scores from daily diaries will be compared to baseline overall and by group (AT + CMM and ATx + CMM)
Measured: 30- and 90-days post-treatment
Brief Pain Inventory (BPI)
Changes from baseline scores overall and by group (AT + CMM and ATx + CMM)
Measured: 30- and 90-days post-treatment
Daily Sleep Interference Scale (DSIS)
Changes from baseline scores overall and by group (AT + CMM and ATx + CMM)
Measured: 30- and 90-days post-treatment
EQ-5D-3L
Changes from baseline scores overall and by group (AT + CMM and ATx + CMM)
Measured: 30- and 90-days post-treatment
Patient Global Impression of Change (PGIC)
Changes from baseline scores overall and by group (AT + CMM and ATx + CMM). In addition, the proportion of subjects with a minimal clinically important change from baseline will be compared between groups.
Measured: 30- and 90-days post-treatment
Depression Anxiety Stress Scales (DASS)
Changes from baseline scores overall and by group (AT + CMM and ATx + CMM)
Measured: 30- and 90-days post-treatment
Pain Disability Index (PDI)
Changes from baseline scores overall and by group (AT + CMM and ATx + CMM). In addition, the proportion of subjects with a minimal clinically important change from baseline will be compared between groups.
Measured: 30- and 90-days post-treatment
Norfolk Quality of Life-Diabetic Neuropathy (QOL-DN) Questionnaire
Changes from baseline scores overall and by group (AT + CMM and ATx + CMM)
Measured: 30- and 90-days post-treatment
In-clinic VAS Pain Scores
Changes from baseline scores overall and by group (AT + CMM and ATx + CMM)
Measured: 30- and 90-days post-treatment
Increase from baseline pain medication within four weeks of the Day 90 visit (based on prescribed doses)
Changes from baseline scores overall and by group (AT + CMM and ATx + CMM)
Measured: 30- and 90-days post-treatment
Proportion of subjects who discontinue treatment
Proportion of subjects who discontinue treatment will be compared between groups
Measured: 30- and 90-days post-treatment
Neurological Exam - percentage of treatment arm with a change in neurological status
Percentage of treatment arm (including crossover subjects) with a change in neurological status as determined by neurological exam on Day 90 after start of active treatment.
Measured: 90 days post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2022
- Study start15 Dec 2022
- Primary completion23 Aug 2023
- Study completion22 Nov 2023
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 NeuralgiaStudies 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
- Prospective, controlled, double blinded, randomized, multi-center clinical trial in which up to 80 subjects diagnosed with painful diabetic neuropathy will be randomized 3:1 into one of two treatment groups: 1. Axon Therapy plus CMM (AT+CMM) 2. Sham plus CMM (Sham+CMM)
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 93 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
- NCT05620225
- Sponsor's protocol ID
- NLM-004
- Status last verified
- Aug 2023
- First submitted
- 9 Nov 2022
- Last updated
- 11 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Brown L, Gage E, Cordner H, Kapural L, Rosenberg J, Bedder M. Safety and Efficacy of Magnetic Peripheral Nerve Stimulation for Treating Painful Diabetic Neuropathy. Neuromodulation. 2025 Dec;28(8):1366-1373. doi: 10.1016/j.neurom.2025.03.074. Epub 2025 Apr 30.
PubMed 40304652
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Clinical Trial Comparing the Safety and Effectiveness of Axon Therapy and Conventional Medical Management (AT+CMM) for the Treatment of Painful Diabetic Neuropathy to Sham and Conventional Medical Management (Sham+CMM)
- ClinicalTrials.gov ID
- NCT05620225
- Acronym / sponsor ID
- NLM-004
- Conditions
- Neuralgia, Neuropathic Pain, Painful Diabetic Neuropathy
- Keywords
- transcutaneous magnetic stimulation, axon therapy, peripheral neuropathic pain, diabetic neuropathy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 93 participants (actual)
- Lead sponsor
- NeuraLace Medical, Inc.Industry (pharma, biotech, devices)
- Study start
- 15 Dec 2022 (actual)
- Primary completion
- 23 Aug 2023 (actual)
- Study completion
- 22 Nov 2023 (actual)
- First posted
- 17 Nov 2022 (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 plus conventional medical management (CMM) to Sham plus CMM in reducing neuropathic pain in patients with painful diabetic neuropathy (PDM).
Detailed description
This is a two-phase study.
Phase 1 is a double blinded, two-arm, randomized, multi-center clinical trial to assess 1-month efficacy as compared to a sham group. Up to approximately 80 subjects diagnosed with painful diabetic neuropathy will be randomized 3:1 into one of two treatment groups:
- Axon Therapy plus CMM (AT+CMM)
- Sham plus CMM (Sham+CMM)
Subjects will be consented, screened, and then undergo a 7-day baseline assessment period. Subjects will be asked to record pain, numbness, and sleep scores via a twice daily electronic diary. Subjects who meet inclusion criteria, including diary compliance, will undergo an in-clinic baseline evaluation (Day 1), be randomized, and start their treatments.
All subjects will return to the clinic for treatments as follows:
● Day 1 - 30: 6 treatments
- Week 1: 3 treatments
- Week 2-4: Weekly treatments
All subjects will return to the clinic for follow-up assessment at Day 30 (± 5 days). At the Day 30 visits subjects will be asked if they want to participate in Phase 2 of the study.
Phase 2 of the study is an unblinded, one-arm, multi-center trial to assess extended efficacy of the treatment. At Day 30, subjects will be unblinded and allowed to remain in the study for an additional 60 (AT+CMM) to 90 (ATx+CMM) days. Those in the Sham arm can choose to crossover to active treatment ( ATx+CMM).
Subjects in the AT+CMM arm will return to the clinic as follows:
- Month 2: Bi-weekly treatment
- Month 3: Treatments every 2-4 weeks
- Additional treatments to treat flare ups; defined as an episode of pain with a VAS 6.
Subjects in the ATx+CMM arm will return to the clinic as follows:
- Month 2: 6 treatments
- Week 1: 3 treatments
- Week 2-4: Weekly treatments
- Month 3: Bi-weekly treatment
- Month 4: Treatments every 2-4 weeks
- Additional treatments to treat flare ups; defined as an episode of pain with a VAS 6.
Subjects who do not choose to remain in the study will be monitored for 30 days for AEs and then they will exit the study. The subject's reason for exiting the study will be recorded.
In addition to in-clinic assessments and treatments, all subjects will complete an electronic twice daily diary through Day 30 of the study (Day 60 for ATx+CMM subjects). Subjects will receive weekly phone follow-up for diary reminders and to assess for the occurrence of adverse events. Weekly phone follow-up will occur only during weeks when the subject is not seen in the clinic.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Prospective, controlled, double blinded, randomized, multi-center clinical trial in which up to 80 subjects diagnosed with painful diabetic neuropathy will be randomized 3:1 into one of two treatment groups: 1. Axon Therapy plus CMM (AT+CMM) 2. Sham plus CMM (Sham+CMM)
| Arm | Type | Receives |
|---|---|---|
| Axon Therapy + CMM | Experimental | Device: Axon Therapy and CMMSubjects will be consented, screened, and then undergo a 7-day baseline assessment period. Subjects will be asked to record pain, numbness, and sleep scores via a twice daily electronic diary. Subjects who meet inclusion criteria, including diary compliance, will undergo an in-clinic baseline evaluation (Day 1), be randomized, and start their treatments. All subjects will return to the clinic for treatments as follows: ● Day 1 - 30: 6 treatments * Week 1: 3 treatments * Week 2-4: Weekly treatments All subjects will return to the clinic for follow-up assessment at Day 30 (± 5 days). At the Day 30 visits subjects will be asked if they want to participate in Phase 2 of the study. |
| Sham + CMM | Sham comparator | Device: Sham and CMMSubjects will be consented, screened, and then undergo a 7-day baseline assessment period. Subjects will be asked to record pain, numbness, and sleep scores via a twice daily electronic diary. Subjects who meet inclusion criteria, including diary compliance, will undergo an in-clinic baseline evaluation (Day 1), be randomized, and start their treatments. All subjects will return to the clinic for treatments as follows: ● Day 1 - 30: 6 treatments * Week 1: 3 treatments * Week 2-4: Weekly treatments All subjects will return to the clinic for follow-up assessment at Day 30 (± 5 days). At the Day 30 visits subjects will be asked if they want to participate in Phase 2 of the study. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not 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 electronic diary for up to 60 days.
- Subject must be literate in English to fill out the study questionnaires.
- Men or women of any race or ethnicity who are 18-85 years of age.
- Subjects must not have a Body Mass Index >40.
Key exclusion criteria (19 listed)
- Subjects with neuropathic pain due to post-herpetic neuropathy, HIV, trigeminal neuralgia; subjects whose post- traumatic neuropathic pain is categorized as central (e.g., spinal cord injury) rather than peripheral.
- Subjects with any other chronic or recurrent pain syndrome rated greater than "mild" on a mild-moderate-severe scale, or which the investigator judges may interfere with the patients ability to report their pain accurately.
- Any disorder that may be confused with PDN, such as tarsal tunnel syndrome, sciatica, bunions, ischemic claudication or arthritis of the feet or ankles.
- 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.
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 |
|---|---|---|
| Axon Therapy and CMMtranscutaneous magnetic stimulation (TMS) | Device | Axon Therapy + CMM |
| Sham and CMMSham and CMM | Device | Sham + CMM |
Primary outcome
Comparison of the Proportion of Responders
Time frame: 30 days
The primary efficacy endpoint is a between groups comparison of pain change from baseline to 30 days.
Comparison of therapy-related AEs between the 2 Study arms
Time frame: 30 days
The primary safety endpoint for this study is a comparison of therapy-related AEs through Day 30 between the 2 arms of the Study.
13 secondary outcomes
Visual Analog Scale (VAS) for Pain
Time frame: 30- and 90-days post-treatment
VAS for Numbness
Time frame: 30- and 90-days post-treatment
Brief Pain Inventory (BPI)
Time frame: 30- and 90-days post-treatment
Daily Sleep Interference Scale (DSIS)
Time frame: 30- and 90-days post-treatment
EQ-5D-3L
Time frame: 30- and 90-days post-treatment
Patient Global Impression of Change (PGIC)
Time frame: 30- and 90-days post-treatment
Depression Anxiety Stress Scales (DASS)
Time frame: 30- and 90-days post-treatment
Pain Disability Index (PDI)
Time frame: 30- and 90-days post-treatment
Norfolk Quality of Life-Diabetic Neuropathy (QOL-DN) Questionnaire
Time frame: 30- and 90-days post-treatment
In-clinic VAS Pain Scores
Time frame: 30- and 90-days post-treatment
Increase from baseline pain medication within four weeks of the Day 90 visit (based on prescribed doses)
Time frame: 30- and 90-days post-treatment
Proportion of subjects who discontinue treatment
Time frame: 30- and 90-days post-treatment
Neurological Exam - percentage of treatment arm with a change in neurological status
Time frame: 90 days post-treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2024.
- Derived from this study: PubMed 40304652Brown L, Gage E, Cordner H, Kapural L, Rosenberg J, Bedder M. Safety and Efficacy of Magnetic Peripheral Nerve Stimulation for Treating Painful Diabetic Neuropathy. Neuromodulation. 2025 Dec;28(8):1366-1373. doi: 10.1016/j.neurom.2025.03.074. Epub 2025 Apr 30.
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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
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Axon Therapy and CMM in people with Neuralgia and Neuropathic Pain, run by NeuraLace Medical, Inc. at 7 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 19 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: finished, as of the sponsor's last update on 11 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 7 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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: 30 days). The study lists 2 primary outcomes in all. 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 NCT05620225, 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 11 Jul 2024.