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

NCT06162403 | Recruiting

• 2 other identifiers: 2023-0368NCI-2023-10303
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Chemotherapy-induced Peripheral Neuropathy; Peripheral Nerve Stimulation

Outcome Measures

Primary Outcomes (1)

• Safety and adverse events (AEs)

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

  Through study completion; an average of 1 year.

Study Arms (1)

Peripheral Nerve Stimulation

EXPERIMENTAL

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.

Other: Peripheral Nerve Stimulation

Interventions

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.

Peripheral Nerve Stimulation

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

MD Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Related Links

• MD Anderson Cancer Center

Study Officials

• Saba Javed, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Saba Javed, MD

CONTACT

(713) 792-9530; sjaved@mdanderson.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 30, 2023
• First Posted: December 8, 2023
• Study Start: February 22, 2024
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: February 19, 2026

Record last verified: 2026-02

Locations

US (1)