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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
Must not have
Patients with open skin lesion or undergoing antibiotic therapy for local for systemic infection
Patients with painful diabetic peripheral neuropathy or preexisting peripheral neuropathy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group

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.
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.
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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have an open skin wound or am on antibiotics for an infection.
Select...
I have nerve pain due to diabetes or existing nerve damage.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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.

Find a Location

Who is running the clinical trial?

Foundation for Anesthesia Education and ResearchOTHER
13 Previous Clinical Trials
34,497 Total Patients Enrolled
M.D. Anderson Cancer CenterLead Sponsor
3,073 Previous Clinical Trials
1,803,302 Total Patients Enrolled
5 Trials studying Peripheral Neuropathy
235 Patients Enrolled for Peripheral Neuropathy
Saba Javed, M DPrincipal InvestigatorM.D. Anderson Cancer Center
~13 spots leftby Apr 2026
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