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

ConditionNeuropathy;Peripheral

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorM.D. Anderson Cancer Center

About this trial

To learn if a process called neuromodulation can help to improve pain due to CIP

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

Abbott® DRG / Abbott®/Medtronic® SCS
Device
Participants will receive 1 of 2 neuromodulation procedures based on if participants are expected to have an MRI in the near future.
Control Group
Other intervention
Participants will not receive any intervention

Treatment groups

24 Participants

are divided into 2 treatment groups

Group A: Treatment GroupExperimental treatment 1 intervention

Group B: Control GroupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0

Time frame

through study completion; an average of 1 year.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

M.D. Anderson Cancer Center

Lead sponsor

Foundation for Anesthesia Education and Research

Collaborator

Source ClinicalTrials.gov

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