Recruiting

Peripheral Nerve Stimulation

Sponsor:

M.D. Anderson Cancer Center

Code:

NCT06162403

Conditions

Peripheral Nerve Stimulation

Chemotherapy-induced Peripheral Neuropathy

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Peripheral Nerve Stimulation

Study Details

Brief summary:

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

Conditions

Peripheral Nerve Stimulation

Chemotherapy-induced Peripheral Neuropathy

Study ID

NCT06162403

Start date

Feb 22, 2024

Status verified date

Aug, 2026

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Dec 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Enrollment

10 participants

Anticipated

Intervention Model

Single group

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: 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.

Interventions

Peripheral Nerve Stimulation

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 outcome measure

  • Safety and adverse events (AEs) [ Time Frame: Through study completion; an average of 1 year. ]

Central Contacts and Locations

Central contacts

Saba Javed, MD

(713) 792-9530sjaved@mdanderson.org

Locations

MD Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Saba Javed, MD

713-792-9530sjaved@mdanderson.org

Principal Investigator:

Saba Javed, MD

More Information

Sponsor

M.D. Anderson Cancer Center

Last update posted

Aug 10, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by M.D. Anderson Cancer Center on 2026-08-10.