NeuralgiamPNS-CHNCT05935956
Safety and Effectiveness of Magnetic Peripheral Nerve Stimulation for the Treatment of Chemotherapy Induced Neuropathy
An observational study of Neuralgia and Neuropathic Pain, run by NeuraLace Medical, Inc. at 1 site in United States.
Trial summary
Assess the safety and effectiveness of Axon Therapy in the treatment of chemotherapy-induced neuropathy Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Neuralgia, Neuropathic Pain, Chemotherapy-induced Peripheral Neuropathy
- What is being tested?
- Magnetic Peripheral Nerve Stimulation
- Type of treatment
- Medical device
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Jun 2023to 21 Dec 2023
- Phase
- Observational
- 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
Study population: Approximately twenty (20) subjects aged 18-85 years old and presenting with chemotherapy induced neuropathy will be enrolled at 1 site in the United States.
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 for 90 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.
- Subject must have chemotherapy induced neuropathy for more than three months per medical history.
- Subject has a pain score >5 on a VAS at Enrollment/Screening Visit.
- Subject has completed at least one of the two daily pain diary entries on at least three 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 has been on a stable pain medication regimen for at least 28 days, as determined by the investigator or is not taking pain medications, at the baseline assessment in this study.
Who cannot join
- Subjects with neuropathic pain due to post-herpetic neuropathy, HIV, trigeminal neuralgia, carpal or tarsal 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.
- Participation in any other clinical trial within 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.
Show all 13Show fewer
- 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, civil litigation, or disability claims; Subjects with fully resolved litigation and compensation claims can participate.
- Phantom limb pain or pain that feels like it is coming from a body part that is no longer there.
- Subjects with shrapnel or ferromagnetic objects
- Subject is currently taking a morphine equivalent daily dose > 120 mg/day.
- Subject is currently pregnant or 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Carolinas Pain Institute and Center for Clinical Research
Winston-Salem, North Carolina, 27103
About this study
Official title: An Observational, Single Arm, Open Label Study Evaluating the Safety and Effectiveness of Magnetic Peripheral Nerve Stimulation (mPNS) for the Treatment of Chemotherapy Induced Neuropathy (mPNS-CH)
Assess the safety and effectiveness of Axon Therapy in the treatment of chemotherapy-induced neuropathy
Read the detailed description
This is an observational, single arm, open label study in which up to 20 subjects diagnosed with chemotherapy induced neuropathy will be treated with mPNS.
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 and start their treatment.
All subjects will return to the clinic for follow-up assessment at Day 30 (± 14 days) and Day 90 (± 14 days) and will return to the clinic for mPNS 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
- Month 3: Treatments every 2-4 weeks
- Additional treatments to treat flare ups; defined as an episode of pain with a VAS of at least 5 following an increase in daily activities.
- The Lead Investigator is provided the discretion to modify the treatment protocol based on subject response.
In addition to in-clinic assessments and treatments, all subjects will complete an electronic twice daily diary through 90 days of the study. Subjects will receive weekly phone follow-up for diary reminders and to assess for the 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.
- Being tested
- Magnetic Peripheral Nerve Stimulation
- Keywords
- Transcutaneous Magnetic Peripheral Nerve Stimulation, Axon Therapy, Peripheral Neuropathy, Chemotherapy-induced Peripheral Neuropathy
- 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.
Magnetic Peripheral Nerve StimulationDevice
Also called Axon Therapy
Magnetic Peripheral Nerve Stimulation
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness of mPNS for treating chemotherapy-induced neuropathy, measured by a reduction in pain at Day 90 as compared to Baseline, using a visual analog scale (VAS).
The primary effectiveness endpoint is to demonstrate a reduction in pain at Day 90 as compared to Baseline where pain is measured in-clinic using a visual analog scale (VAS). Scores on the VAS range from 0 (no pain) to 10 (worst possible pain).
Measured: 90 days
Safety of mPNS for the treatment of chemotherapy-induced neuropathy, as measured by the incidence of therapy-related adverse events (AEs) through Day 90.
The primary safety endpoint is the occurrence of therapy-related adverse events (AEs) through Day 90.
Measured: 90 days
Secondary outcomes (6)
Patient Reported Outcome (PRO) assessment via the Pain Disability Index (PDI), which measures the degree that chronic pain interferes with normal role functioning.
The PDI is a short, self-reported instrument for measuring the degree of interference with normal role functioning caused by chronic pain. The form uses a 10-point scale ranging from 0 (no disability) to 10 (total disability) to rate pain-related interference in the following categories: family/home responsibilities, recreation, social activity, occupation, sexual behavior, self-care, and life-support activity. The total scores range from a minimum of 0 to a maximum of 70, where a higher score indicates higher pain-related interference.
Measured: Baseline and 90 days
PRO assessment via the EuroQol Group Quality of Life Questionnaire (EQ-5D-3L), which measures the impact that chronic pain has on 5 aspects of a subject's quality of life.
The EQ-5D-3L is a descriptive questionnaire comprised of 5 dimensions; each describing a different aspect of health: Mobility; Self-Care; Usual Activities; Pain/Discomfort and Anxiety/Depression on a 3-level response scale. The three levels represent no problem, some/moderate problems, and severe/extreme problems across the 5 dimensions. The EQ-5D-3L summary index is derived by combining one level from each of the 5 dimensions and converting it to a single summary index or health utility value, which ranges from 0 for worst imaginable health state to 100 for best imaginable health state. Together 243 health states are possible (35 combinations). Overall scores for the EQ-5D-3L index range from -0.109 to 1, with low scores representing a higher level of dysfunction and hence, a worse outcome.
Measured: Baseline and 90 days
PRO assessment via the Daily Sleep Interference Scale (DSIS), which measures how much a subject's pain interferes with that subject's sleep.
The DSIS describes the degree that pain has interfered with the subject's sleep. Response options range from 0 (Did not interfere with sleep) to 10 (Completely interfered with sleep-unable to sleep due to pain). A lower score indicates a better outcome.
Measured: Baseline and 90 days
PRO assessment via the Depression Anxiety Stress Scales (DASS), which measures the level of depression, anxiety and stress a subject is experiencing.
The DASS is a 42-item, self-reported rating inventory that measures depression, anxiety, and stress. Each answer is scored on a scale of 0-3 with a total minimum score of 0 and maximum of 126. Scores from 0-9 indicate a normal score, scores of 10-13 indicate mild depression, scores of 14-20 indicate moderate depression, scores of 21-27 indicate severe depression and scores, and a score greater than 28 indicates extremely severe depression.
Measured: Baseline and 90 days
PRO assessment via the Brief Pain Inventory (BPI-SF) to assess the severity of pain and the impact of pain on daily functions.
The BPI-SF is a self-administered questionnaire developed to assess the severity of pain and the impact of pain on daily functions. The BPI-SF consists of 5 questions. Four items measure pain on 11-point response scales from 0 to 10 ("No Pain" to "Pain as bad as you can imagine"). Another item, containing 7 sub-questions, evaluates the level of pain interference with daily functioning on 11-point response scales from 0 to 10 ("Does not interfere" to "Completely interferes"). Lower scores indicate better outcomes.
Measured: Baseline and 90 days
PRO assessment via the Patient Global Impression of Change (PGIC), which measures patient satisfaction after treatment with magnetic peripheral nerve stimulation (NeuraLace Axon Therapy)
The PGIC is a self-administered instrument that measures the proportion of subjects in each PGIC satisfaction category that has improved post-treatment with magnetic peripheral nerve stimulation (NeuraLace Axon Therapy), based on a scale ranging from 1 (very much improved) to 7 (very much worse). The subject is presented with a 7-point rating scale containing the options "very much improved", "much improved", "minimally improved", "no change", "minimally worse", "much worse", and "very much worse". A lower score indicates a better outcome.
Measured: Day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2023
- Study start9 Jun 2023
- Primary completion21 Dec 2023
- Study completion21 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- NeuraLace Medical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Carrie Johnson, MD, PhD, Principal investigator, Carolinas Pain Institute and Center for Clinical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05935956
- Sponsor's protocol ID
- NLM-005
- Acronym
- mPNS-CH
- Status last verified
- Jul 2023
- First submitted
- 12 Jun 2023
- Last updated
- 11 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
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
- An Observational, Single Arm, Open Label Study Evaluating the Safety and Effectiveness of Magnetic Peripheral Nerve Stimulation (mPNS) for the Treatment of Chemotherapy Induced Neuropathy (mPNS-CH)
- ClinicalTrials.gov ID
- NCT05935956
- Acronym / sponsor ID
- mPNS-CH / NLM-005
- Keywords
- Transcutaneous Magnetic Peripheral Nerve Stimulation, Axon Therapy, Peripheral Neuropathy, Chemotherapy-induced Peripheral Neuropathy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- NeuraLace Medical, Inc.Industry (pharma, biotech, devices)
- Study start
- 9 Jun 2023 (actual)
- Primary completion
- 21 Dec 2023 (actual)
- Study completion
- 21 Dec 2023 (actual)
- First posted
- 7 Jul 2023 (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.
Assess the safety and effectiveness of Axon Therapy in the treatment of chemotherapy-induced neuropathy
Detailed description
This is an observational, single arm, open label study in which up to 20 subjects diagnosed with chemotherapy induced neuropathy will be treated with mPNS.
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 and start their treatment.
All subjects will return to the clinic for follow-up assessment at Day 30 (± 14 days) and Day 90 (± 14 days) and will return to the clinic for mPNS 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
- Month 3: Treatments every 2-4 weeks
- Additional treatments to treat flare ups; defined as an episode of pain with a VAS of at least 5 following an increase in daily activities.
- The Lead Investigator is provided the discretion to modify the treatment protocol based on subject response.
In addition to in-clinic assessments and treatments, all subjects will complete an electronic twice daily diary through 90 days of the study. Subjects will receive weekly phone follow-up for diary reminders and to assess for the 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
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Approximately twenty (20) subjects aged 18-85 years old and presenting with chemotherapy induced neuropathy will be enrolled at 1 site in the United States.
Key inclusion criteria (8 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 for 90 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.
- Subject must have chemotherapy induced neuropathy for more than three months per medical history.
Key exclusion criteria (13 listed)
- Subjects with neuropathic pain due to post-herpetic neuropathy, HIV, trigeminal neuralgia, carpal or tarsal 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.
- Participation in any other clinical trial within 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 |
|---|---|---|
| Magnetic Peripheral Nerve StimulationAlso: Axon TherapyMagnetic Peripheral Nerve Stimulation | Device | – |
Primary outcome
Effectiveness of mPNS for treating chemotherapy-induced neuropathy, measured by a reduction in pain at Day 90 as compared to Baseline, using a visual analog scale (VAS).
Time frame: 90 days
The primary effectiveness endpoint is to demonstrate a reduction in pain at Day 90 as compared to Baseline where pain is measured in-clinic using a visual analog scale (VAS). Scores on the VAS range from 0 (no pain) to 10 (worst possible pain).
Safety of mPNS for the treatment of chemotherapy-induced neuropathy, as measured by the incidence of therapy-related adverse events (AEs) through Day 90.
Time frame: 90 days
The primary safety endpoint is the occurrence of therapy-related adverse events (AEs) through Day 90.
6 secondary outcomes
Patient Reported Outcome (PRO) assessment via the Pain Disability Index (PDI), which measures the degree that chronic pain interferes with normal role functioning.
Time frame: Baseline and 90 days
PRO assessment via the EuroQol Group Quality of Life Questionnaire (EQ-5D-3L), which measures the impact that chronic pain has on 5 aspects of a subject's quality of life.
Time frame: Baseline and 90 days
PRO assessment via the Daily Sleep Interference Scale (DSIS), which measures how much a subject's pain interferes with that subject's sleep.
Time frame: Baseline and 90 days
PRO assessment via the Depression Anxiety Stress Scales (DASS), which measures the level of depression, anxiety and stress a subject is experiencing.
Time frame: Baseline and 90 days
PRO assessment via the Brief Pain Inventory (BPI-SF) to assess the severity of pain and the impact of pain on daily functions.
Time frame: Baseline and 90 days
PRO assessment via the Patient Global Impression of Change (PGIC), which measures patient satisfaction after treatment with magnetic peripheral nerve stimulation (NeuraLace Axon Therapy)
Time frame: Day 90
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.
- Individual participant dataSharing planned: No
Related trials for Neuralgia
RecruitingObservational study
Pain Phenotypes in Individuals With Multiple Sclerosis
Multiple Sclerosis, Chronic Pain
Enrolling by invitationPhase 4
Low Dose Naltrexone Therapy for Complex Regional Pain Syndrome
Complex Regional Pain Syndrome, Chronic Pain
RecruitingPhase 2
Effectiveness of Phenotype-based Pain Management Guidelines for Head and Neck Cancer Related Pain: a Pilot Study
Cancer Pain, Orofacial Pain
RecruitingPhase 2
A Master Protocol Study (LY900028) of Multiple Intervention-Specific-Appendices (ISAs) in Participants With Chronic Pain
Osteoarthritis, Knee, Diabetic Neuropathic Pain
RecruitingObservational study
Trigeminal Neuralgia Electrophysiology
Trigeminal Neuralgia
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.
Carrie Johnson, MD, PhD principal investigator
Carolinas Pain Institute and Center for Clinical Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neuralgia and Neuropathic Pain, run by NeuraLace Medical, Inc. at 1 site 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 8 inclusion and 13 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 1 site 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?
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?
Effectiveness of mPNS for treating chemotherapy-induced neuropathy, measured by a reduction in pain at Day 90 as compared to Baseline, using a visual analog scale (VAS). (time frame: 90 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?
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.