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Procedure

Peripheral Nerve Stimulation for Peripheral Neuropathy

N/A

Waitlist Available

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)

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Safety and adverse events (AEs)

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 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor

2,975 Previous Clinical Trials

1,789,509 Total Patients Enrolled

5 Trials studying Peripheral Neuropathy

235 Patients Enrolled for Peripheral Neuropathy

Saba Javed, MDPrincipal InvestigatorM.D. Anderson Cancer Center

1 Previous Clinical Trials

45 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are any new research participants being welcomed into this experiment?

"Clinicaltrials.gov confirms that this trial, which began in April 2024 and was last updated on November 2023, is not actively enrolling participants at the moment. However, there are currently 166 other trials with open recruitment."

Answered by AI

Are individuals aged 35 and over eligible for participation in this experimental research?

"This medical study is enrolling individuals who have attained the age of majority and are under 85 years old."

Answered by AI

Do I meet the prerequisites for taking part in this medical study?

"Eligible enrollees must have a diagnosis of peripheral neuropathy and be between 18 to 85 years old. Thus far, 10 participants are taking part in this clinical study."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2024. "Exploring the Benefit of Peripheral Nerve Stimulation in Treating Pain From Chemo-induced Peripheral Neuropathy: A Longitudinal Single Center Feasibility Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06162403.

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