Assess the safety and effectiveness of Axon Therapy in the treatment of chemotherapy-induced neuropathy
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 Type
OBSERVATIONAL
Enrollment
14
Magnetic Peripheral Nerve Stimulation
Carolinas Pain Institute and Center for Clinical Research
Winston-Salem, North Carolina, United States
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).
Time frame: 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.
Time frame: 90 days
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.
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.
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.
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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.
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.
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.
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.
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.
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.
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)
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.
Time frame: Day 90