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

M.D. Anderson Cancer Center10 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Peripheral Nerve Stimulation Chemotherapy-induced Peripheral Neuropathy

Interventions

Peripheral Nerve StimulationOTHER

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

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 * Participants with conditions that conflict with the SPRINT PNS System Indications for Use, including Contraindications and Warnings.

Locations (1)

MD Anderson Cancer Center

Houston, Texas, United States

RECRUITING

Outcomes

Primary Outcomes

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

Time frame: Through study completion; an average of 1 year.

Central Contacts

Saba Javed, MD

CONTACT

(713) 792-9530 sjaved@mdanderson.org

Data from ClinicalTrials.gov

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