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

Last updated: February 7, 2025
Sponsor: M.D. Anderson Cancer Center
Overall Status: Active - Recruiting

Phase

N/A

Condition

Neurologic Disorders

Treatment

Peripheral Nerve Stimulation

Clinical Study ID

NCT06162403
2023-0368
NCI-2023-10303
  • Ages 18-85
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Participants diagnosed with chronic (≥90 days duration) CIPN (due to either vincaalkaloids, taxanes, bortezomib, thalidomide, platinum-based compounds or ionizingirradiation) of the lower extremity, seen at Pain Management Center at MD AndersonCancer 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 ofenrollment

Exclusion

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 forsystemic infection

  • Participants with allergies to local anesthesia, steroids, or adhesives

  • Participants with conditions that conflict with the SPRINT PNS System Indicationsfor Use, including Contraindications and Warnings.

Study Design

Total Participants: 10
Treatment Group(s): 1
Primary Treatment: Peripheral Nerve Stimulation
Phase:
Study Start date:
February 22, 2024
Estimated Completion Date:
December 31, 2027

Study 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.

Connect with a study center

  • MD Anderson Cancer Center

    Houston, Texas 77030
    United States

    Active - Recruiting

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