Exploring the Benefit of Neuromodulation in Treating Chemo-induced Peripheral Neuropathy Using Peripheral Neuropathy Markers (Meissner's Corpuscles and Epidermal Nerve Fiber Density) and Sensory Testing (Quantitative Sensory and Gait Testing): A Single Center Feasibility Study

Study Overview
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Brief Summary
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To learn if a process called neuromodulation can help to improve pain due to CIP

Detailed Description
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Inclusion Criteria: Ability to understand and the willingness to sign a written informed consent document Patients diagnosed with CIPN lower extremity due to either vinca alkaloids, taxanes, bortezomib, thalidomide, platinum-based compounds Patients seen at Pain Management Center at MD Anderson Cancer Center Patient ages greater or equal to 18 years but less than or equal to 85 years Exclusion Criteria: Patients with cognitive dysfunction Patient with recent history (<6 months) of drug or alcohol abuse Patients with open skin lesion or undergoing antibiotic therapy for local for systemic infection Patients with painful diabetic peripheral neuropathy or preexisting peripheral neuropathy

Official Title
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Exploring the Benefit of Neuromodulation in Treating Chemo-induced Peripheral Neuropathy Using Peripheral Neuropathy Markers (Meissner's Corpuscles and Epidermal Nerve Fiber Density) and Sensory Testing (Quantitative Sensory and Gait Testing): A Single Center Feasibility Study

Conditions
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Neuropathy;Peripheral

Intervention / Treatment
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* Device: Abbott® DRG / Abbott®/Medtronic® SCS
* Other: Control Group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Ability to understand and the willingness to sign a written informed consent document Patients diagnosed with CIPN lower extremity due to either vinca alkaloids, taxanes, bortezomib, thalidomide, platinum-based compounds Patients seen at Pain Management Center at MD Anderson Cancer Center Patient ages greater or equal to 18 years but less than or equal to 85 years Exclusion Criteria Patients with cognitive dysfunction Patient with recent history (<6 months) of drug or alcohol abuse Patients with open skin lesion or undergoing antibiotic therapy for local for systemic infection Patients with painful diabetic peripheral neuropathy or preexisting peripheral neuropathy

Ages Eligible for Study
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Minimum Age: 18 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
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment Group<br>Group 1 will receive neuromodulation. | Device: Abbott® DRG / Abbott®/Medtronic® SCS<br>* Participants will receive 1 of 2 neuromodulation procedures based on if participants are expected to have an MRI in the near future.<br>|
| Experimental: Control Group<br>Group 2 will not receive neuromodulation. | Other: Control Group<br>* Participants will not receive any intervention<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |