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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

Recruiting
18 - 85 years of age
Both
Phase N/A

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Overview

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

Description

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.

Eligibility

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.

Study details

Peripheral Nerve Stimulation, Chemotherapy-induced Peripheral Neuropathy

NCT06162403

M.D. Anderson Cancer Center

23 June 2024

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