Peripheral Neuropathy Due to Chemotherapy
Conditions
Brief 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.
Detailed description
Primary Objective: To explore the impact of using closed loop spinal cord stimulation (SCS) on pain control, quality of life, and pain medication use in patients suffering from chemotherapy induced peripheral neuropathy (CIPN). Secondary Objective: To assess the relationship between pain control from closed loop spinal cord stimulation and any associated changes in quantitative sensory testing (QST) and quantitative gait testing (QGT).
Interventions
Participants will receive intervention in the operating room setting
Sponsors
M.D. Anderson Cancer Center
Saluda Medical Pty Ltd
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Numerical Rating Scale (NRS) | Through study completion; an average of 1 year | These scales are 0-10 (0 being no pain \& 10 most extreme pain). |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORMatthew Chung, MD
M.D. Anderson Cancer Center
Outcome results
None listed