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NCT Number: NCT06162403

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

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

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Key information

Conditions

Peripheral Nerve Stimulation Chemotherapy-induced Peripheral Neuropathy

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location status: Recruiting

Location contact

Saba Javed, MD

CONTACT

[email protected]

713-792-9530

Saba Javed, MD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Peripheral Nerve Stimulation

Other

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.

Primary outcomes

  1. Safety and adverse events (AEs)

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

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

Study contacts

Contact information is provided by the study sponsor or research team.

Saba Javed, MD

CONTACT

[email protected]

(713) 792-9530

Sponsors and collaborators

Lead sponsor

M.D. Anderson Cancer Center

Other

Registry information

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Dec 8, 2023
Registry last updated
Feb 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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