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 Center

Status: Enrolling

Conditions: Chemotherapy-induced Peripheral Neuropathy; Peripheral Nerve Stimulation

Treatments: Other: Peripheral Nerve Stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT06162403

NCI-2023-10303 (Other Identifier)

2023-0368

Details and patient eligibility

About

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

Full 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.

Enrollment: 10 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Peripheral Nerve Stimulation

Experimental group

Description:

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.

Treatment:

Other: Peripheral Nerve Stimulation