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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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06121232
Enrollment
24
Registered
2023-11-07
Start date
2023-11-02
Completion date
2026-06-01
Last updated
2026-05-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neuropathy;Peripheral

Brief summary

To learn if a process called neuromodulation can help to improve pain due to CIP

Detailed description

Inclusion Criteria: * Ability to understand and the willingness to sign a written informed consent document * Patients diagnosed with CIPN lower extremity due to either vinca alkaloids, taxanes, bortezomib, thalidomide, platinum-based compounds * Patients seen at Pain Management Center at MD Anderson Cancer Center * Patient ages greater or equal to 18 years but less than or equal to 85 years Exclusion Criteria: * Patients with cognitive dysfunction * Patient with recent history (\<6 months) of drug or alcohol abuse * Patients with open skin lesion or undergoing antibiotic therapy for local for systemic infection * Patients with painful diabetic peripheral neuropathy or preexisting peripheral neuropathy

Interventions

DEVICEAbbott® DRG / Abbott®/Medtronic® SCS

Participants will receive 1 of 2 neuromodulation procedures based on if participants are expected to have an MRI in the near future.

OTHERControl Group

Participants will not receive any intervention

Sponsors

M.D. Anderson Cancer Center
Lead SponsorOTHER
Foundation for Anesthesia Education and Research
CollaboratorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Ability to understand and the willingness to sign a written informed consent document * Patients diagnosed with CIPN lower extremity due to either vinca alkaloids, taxanes, bortezomib, thalidomide, platinum-based compounds * Patients seen at Pain Management Center at MD Anderson Cancer Center * Patient ages greater or equal to 18 years but less than or equal to 85 years

Exclusion criteria

* Patients with cognitive dysfunction * Patient with recent history (\<6 months) of drug or alcohol abuse * Patients with open skin lesion or undergoing antibiotic therapy for local for systemic infection * Patients with painful diabetic peripheral neuropathy or preexisting peripheral neuropathy

Design outcomes

Primary

MeasureTime frame
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0through study completion; an average of 1 year.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORSaba Javed, M D

M.D. Anderson Cancer Center

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 27, 2026