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Procedure

Neuromodulation for Peripheral Neuropathy

N/A

Recruiting

Led By Saba Javed, M D

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

Patients diagnosed with CIPN lower extremity due to either vinca alkaloids, taxanes, bortezomib, thalidomide, platinum-based compounds

Patient ages greater or equal to 18 years but less than or equal to 85 years

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

Study Summary

This trial tests if a nerve stimulation treatment can reduce pain for people with Complex Regional Pain Syndrome (CRPS).

Who is the study for?

This trial is for adults aged 18-85 with chemo-induced peripheral neuropathy (CIPN) from specific drugs like vinca alkaloids, taxanes, and platinum-based compounds. Participants must understand the study and consent to join. It's not for those with cognitive issues, recent substance abuse, other types of neuropathy, skin lesions or current infections.Check my eligibility

What is being tested?

The study tests neuromodulation treatments using Abbott® DRG or Abbott®/Medtronic® SCS devices against a control group to see if they can relieve pain associated with CIPN. The effectiveness will be measured through nerve and sensory testing.See study design

What are the potential side effects?

While the side effects are not explicitly listed here, neuromodulation may cause discomfort at the device site, changes in sensation or gait disturbances as it involves electrical stimulation of nerves.

Eligibility Criteria

Inclusion Criteria

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

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I have nerve pain in my legs due to cancer treatment drugs.

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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

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

Trial Design

2Treatment groups

Experimental Treatment

Group I: Treatment GroupExperimental Treatment1 Intervention

Group 1 will receive neuromodulation.

Group II: Control GroupExperimental Treatment1 Intervention

Group 2 will not receive neuromodulation.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Foundation for Anesthesia Education and ResearchOTHER

12 Previous Clinical Trials

34,377 Total Patients Enrolled

M.D. Anderson Cancer CenterLead Sponsor

2,974 Previous Clinical Trials

1,789,450 Total Patients Enrolled

5 Trials studying Peripheral Neuropathy

235 Patients Enrolled for Peripheral Neuropathy

Saba Javed, M DPrincipal InvestigatorM.D. Anderson Cancer Center

Frequently Asked Questions

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

What is the current cohort size of this clinical trial?

"Affirmative. The details on clinicaltrials.gov demonstrate that this medical experiment, which was initially made available on November 2nd 2023 is presently looking for participants. 24 subjects need to be enrolled from 1 healthcare facility."

Answered by AI

Are there currently opportunities to join this medical research study?

"The listing on clinicaltrials.gov reveals that this medical trial is currently searching for participants, with the initial posting of the study taking place on November 2nd 2023 and its most recent edit occurring concurrently."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Exploring the Benefit of Neuromodulation in Treating Chemo-induced Peripheral Neuropathy Using Peripheral Neuropathy Markers (Meissner's Corpuscles and Epidermal Nerve Fiber Density) and Sensory Testing (Quantitative Sensory and Gait Testing): A Single Center Feasibility Study

2023. "Exploring the Benefit of Neuromodulation in Treating Chemo-induced Peripheral Neuropathy Using Peripheral Neuropathy Markers (Meissner's Corpuscles and Epidermal Nerve Fiber Density) and Sensory Testing (Quantitative Sensory and Gait Testing): A Single Center Feasibility Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06121232.

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