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

M.D. Anderson Cancer Center

Status: Active, not recruiting

Conditions: Neuropathy;Peripheral

Treatments: Device: Abbott® DRG / Abbott®/Medtronic® SCS; Other: Control Group

Study type: Interventional

Funder types: Other

Identifiers

NCT06121232

NCI-2023-09269 (Other Identifier)

2023-0301

Details and patient eligibility

About

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

Full 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

Enrollment: 24 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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24 participants in 2 patient groups

Treatment Group

Experimental group

Description:

Group 1 will receive neuromodulation.

Treatment:

Device: Abbott® DRG / Abbott®/Medtronic® SCS

Control Group

Experimental group

Description:

Group 2 will not receive neuromodulation.

Treatment:

Other: Control Group