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

Not Applicable

Recruiting

• Conditions: Chemotherapy-induced Peripheral Neuropathy; Peripheral Nerve Stimulation
• Interventions: Other: Peripheral Nerve Stimulation

• Registration Number: NCT06162403
• Lead Sponsor: M.D. Anderson Cancer Center

Brief Summary

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

Detailed 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.

Study Timeline

• Study First Submitted: 2023-11-30
• Study First Submitted QC: 2023-11-30
• Study First Posted: 2023-12-08
• Study Start: 2024-02-22
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-07
• Last Update Posted: 2025-02-10
• Primary Completion: 2027-12-31
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 10

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Peripheral Nerve Stimulation	Peripheral Nerve Stimulation	Participants will be asked to have PNS leads inserted via a needle, which will provide a mild, stimulating electrical current to the effected nerves 24 hours a day for up to 60 days. Participants will have study visits during and after this time.

Primary Outcome Measures

Name	Time	Method
Safety and adverse events (AEs)	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

Trial Locations

Locations (1)

MD Anderson Cancer Center; 🇺🇸 Houston, Texas, United States