Closed Loop Spinal Cord Stimulation for Chemotherapy Induced Peripheral Neuropathy, a Pilot Study.

Launched by M.D. ANDERSON CANCER CENTER · Sep 25, 2024

Keywords

ClinConnect Summary

This clinical trial is exploring a new treatment option for patients suffering from painful nerve damage caused by chemotherapy, known as chemotherapy-induced peripheral neuropathy (CIPN). The study will investigate the use of closed loop spinal cord stimulation (SCS) to see if it can help reduce pain, improve the quality of life, decrease the need for pain medications, and enhance walking ability in patients experiencing CIPN. The trial aims to find out if this method can provide better relief and support for those affected by this condition.

To participate in the study, you must be at least 18 years old and have a diagnosis of CIPN in your lower limbs. You should not be currently undergoing chemotherapy or immunotherapy and must be able to understand the study and agree to participate by signing a consent form. If you join, you can expect to undergo assessments that measure your pain levels, quality of life, and walking ability throughout the trial. This pilot study is not yet open for recruitment, but it holds promise for improving care for patients dealing with the challenges of CIPN.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Age ≥18 years
• • Diagnosis history of CIPN of lower extremities
• • Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of SCS
• • Ability to understand and the willingness to sign a written informed consent document.
• Exclusion Criteria:
• • Patients undergoing active chemotherapy or immunotherapy
• • Patients undergoing medical litigation.
• • Patients with active infection, being treated with antibiotics
• • Patients that are pregnant or planning to conceive
• • Patients who are receiving any investigational agents.
• • Patients with brain metastases.
• • Patients with cognitive impairment/psychiatric illness/social situations that would limit compliance with study requirements.
• • Patients with history of alternative forms of sensorimotor neuropathies prior to CIPN presentation