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Procedure

Nerve Stimulation for Peripheral Neuropathy

N/A

Recruiting

Led By Saba Javed, MD

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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)

Must not have

Participants with open skin lesion or undergoing antibiotic therapy for local for systemic infection

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion; an average of 1 year.

Awards & highlights

No Placebo-Only Group

Summary

This trial tests if stimulating nerves can reduce pain in people with chemotherapy-related nerve damage.

Who is the study for?

This trial is for adults aged 18-85 with long-term pain from nerve damage caused by certain chemotherapy drugs or radiation, who have finished chemo within the last year. They must be patients at MD Anderson's Pain Management Center and report a pain level of 4 or higher on a scale to 10. People with cognitive issues, recent substance abuse, skin infections, allergies to specific medical materials, pregnancy, or conditions conflicting with the PNS device can't join.

What is being tested?

The study is testing whether Peripheral Nerve Stimulation (PNS), which involves sending electrical signals to nerves through small devices placed under the skin, can reduce pain in people suffering from chronic chemotherapy-induced peripheral neuropathy (CIPN) in their lower extremities.

What are the potential side effects?

While not explicitly stated here, potential side effects of PNS may include discomfort at the stimulation site, infection risk due to implantation procedure, possible allergic reactions to device materials or adhesives used during treatment.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have long-term nerve pain in my legs due to cancer treatment.

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My pain level is 4 or higher on a scale of 0 to 10.

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I am between 18 and 85 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have an open skin wound or am on antibiotics for an infection.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion; an average of 1 year.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion; an average of 1 year.

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion; an average of 1 year. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Safety and adverse events (AEs)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Peripheral Nerve StimulationExperimental Treatment1 Intervention

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.

0 / 4Eligibility criteria met