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OpenTrials
Active, not recruiting

NCT Number: NCT06121232

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

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

Active, not recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Neuropathy;Peripheral Nervous System Diseases Neuritis Neuromuscular Diseases Peripheral Nervous System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

M D Anderson Cancer Center

Houston, Texas, 77030, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Abbott® DRG / Abbott®/Medtronic® SCS

Device

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

Control Group

Other

Participants will not receive any intervention

Primary outcomes

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

    Time frame: through study completion; an average of 1 year.

Sponsors and collaborators

Lead sponsor

M.D. Anderson Cancer Center

Other

Collaborators

  • Foundation for Anesthesia Education and Research

Registry information

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Nov 7, 2023
Registry last updated
May 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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