RecruitingNot Applicable

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

United States10 participantsStarted 2024-02-22

Plain-language summary

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

Who can participate

Age range

18 Years – 85 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Safety and adverse events (AEs)

Timeframe: Through study completion; an average of 1 year.

Trial details

NCT IDNCT06162403

SponsorM.D. Anderson Cancer Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-12-31

Contact for this trial

Saba Javed, MD

(713) 792-9530 sjaved@mdanderson.org

View on ClinicalTrials.gov More Peripheral Nerve Stimulation trials

Who can participate

Age range

18 Years – 85 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.