Clinical trial NCT05935956: Safety and Effectiveness of Magnetic Peripheral Nerve Stimulation for the Treatment of Chemotherapy Induced Neuropathy
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)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neuralgia
Neuropathic Pain
Chemotherapy-induced Peripheral Neuropathy
Keywords: Transcutaneous Magnetic Peripheral Nerve Stimulation
Axon Therapy
Peripheral Neuropathy
Chemotherapy-induced Peripheral Neuropathy
Lead sponsor: NeuraLace Medical, Inc.
Sponsor class: INDUSTRY
First posted: 2023-07-07
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
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.

Brief summary: 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.

Eligibility criteria: Inclusion Criteria:

1. Evidence of a personally signed and dated informed consent indicating that the subject has been informed of all pertinent aspects of the study.
2. 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.
3. Subject must be literate in English to fill out the study questionnaires.
4. Men or women of any race or ethnicity who are 18-85 years of age.
5. Subject must have chemotherapy induced neuropathy for more than three months per medical history.
6. Subject has a pain score \>5 on a VAS at Enrollment/Screening Visit.
7. 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.
8. 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.

Exclusion Criteria:

1. 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.
2. 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).
3. Subjects with skin conditions in the affected dermatome that in the judgment of the investigator could interfere with evaluation of the neuropathic pain condition.
4. Subjects with other pain that may confound assessment or self-evaluation of the peripheral neuropathic pain.
5. Participation in any other clinical trial within 30 days prior to screening and/or during participation in this study.
6. Any subject considered at risk of suicide or self-harm based on investigator judgment and/or the details of a risk assessment.
7. 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.
8. Subjects with pending Worker's Compensation, civil litigation, or disability claims; Subjects with fully resolved litigation and compensation claims can participate.
9. Phantom limb pain or pain that feels like it is coming from a body part that is no longer there.
10. Subjects with shrapnel or ferromagnetic objects
11. Subject is currently taking a morphine equivalent daily dose \> 120 mg/day.
12. 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.
13. Subjects with active drug or alcohol abuse within 1 year prior to screening.

Primary outcomes:
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).
timeFrame: 90 days
measure: Safety of mPNS for the treatment of chemotherapy-induced neuropathy, as measured by the incidence of therapy-related adverse events (AEs) through Day 90.
timeFrame: 90 days
Secondary outcomes:
measure: Patient Reported Outcome (PRO) assessment via the Pain Disability Index (PDI), which measures the degree that chronic pain interferes with normal role functioning.
timeFrame: Baseline and 90 days
measure: 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.
timeFrame: Baseline and 90 days
measure: PRO assessment via the Daily Sleep Interference Scale (DSIS), which measures how much a subject's pain interferes with that subject's sleep.
timeFrame: Baseline and 90 days
measure: PRO assessment via the Depression Anxiety Stress Scales (DASS), which measures the level of depression, anxiety and stress a subject is experiencing.
timeFrame: Baseline and 90 days
measure: PRO assessment via the Brief Pain Inventory (BPI-SF) to assess the severity of pain and the impact of pain on daily functions.
timeFrame: Baseline and 90 days
measure: PRO assessment via the Patient Global Impression of Change (PGIC), which measures patient satisfaction after treatment with magnetic peripheral nerve stimulation (NeuraLace Axon Therapy)
timeFrame: Day 90
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Carolinas Pain Institute and Center for Clinical Research
state: North Carolina
Study officials:
affiliation: Carolinas Pain Institute and Center for Clinical Research
name: Carrie Johnson, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: