RecruitingNot ApplicableNCT06616649
Closed Loop Spinal Cord Stimulation for Chemotherapy Induced Peripheral Neuropathy, a Pilot Study.
Sponsor
M.D. Anderson Cancer Center
Enrollment
10 participants
Start Date
Jul 14, 2025
Study Type
INTERVENTIONAL
Conditions
Summary
To explore the benefits of using closed loop spinal cord stimulation (SCS) in the treatment of patients experiencing painful chemotherapy induced peripheral neuropathy (CIPN) by assessing changes in pain, quality of life, pain medication use, sensory improvement through quantitative sensory testing, and improvement of gait through quantitative gait testing.
Eligibility
Min Age: 18 Years
Inclusion Criteria4
- 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 Criteria8
- 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
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Interventions
DEVICESpinal cord stimulator implant
Participants will receive intervention in the operating room setting
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06616649
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