Exploring the Benefit of Peripheral Nerve Stimulation in Treating Pain From Chemo-induced Peripheral Neuropathy: A Longitudinal Single Center Feasibility Study

Study Overview
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Brief Summary
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To learn if peripheral nerve stimulation (PNS) can help to improve pain in participants with CIPN.

Detailed Description
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Primary objective: To assess Pain intensity (NRS) scores in chemotherapy induced peripheral neuropathy (CIPN) participants before and after use of peripheral nerve stimulation (PNS). Secondary objectives: To assess changes in quantitative sensory testing (QST), gait testing, and skin punch biopsy to compare the integrity of Meissner's corpuscles (MC), pain disability using the Oswestry Disability Index (ODI), pain interference using the Brief Pain Inventory (BPI), and Patient Global Impression of Change (PGIC) in CIPN patients before and after use of PNS.

Official Title
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Exploring the Benefit of Peripheral Nerve Stimulation in Treating Pain From Chemo-induced Peripheral Neuropathy: A Longitudinal Single Center Feasibility Study

Conditions
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Peripheral Nerve Stimulation, Chemotherapy-induced Peripheral Neuropathy

Intervention / Treatment
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* Other: Peripheral Nerve Stimulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants diagnosed with chronic (≥90 days duration) CIPN (due to either vinca alkaloids, taxanes, bortezomib, thalidomide, platinum-based compounds or ionizing irradiation) of the lower extremity, seen at Pain Management Center at MD Anderson Cancer Center Participants reports baseline pain ≥ 4 (0-10 scale, NRS) Participants between ages 18-85 years old Participants who have completed chemotherapy within the previous year at the time of enrollment Exclusion Criteria: Participants with cognitive dysfunction Participants with recent history (<6 months) of drug or alcohol abuse Participants with open skin lesion or undergoing antibiotic therapy for local for systemic infection Participants with allergies to local anesthesia, steroids, or adhesives Pregnant participants Participants with conditions that conflict with the SPRINT PNS System Indications for Use, including Contraindications and Warnings.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Peripheral Nerve Stimulation<br>Participants will be asked to have PNS leads inserted via a needle, which will provide a mild, stimulating electrical current to the effected nerves 24 hours a day for up to 60 days. Participants will have study visits during and after this time. | Other: Peripheral Nerve Stimulation<br>* The leads are inserted through a needle. If needed, the study team may give participants anesthetic (for example, as a cream/gel on your skin and/or as an injection) to numb the area where the leads will be injected.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and adverse events (AEs) | Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0 | Through study completion; an average of 1 year. |