Ensayos clínicos

Inclusion Criteria:

- Adult patients aged 18 to 70 who have been clinically diagnosed with CIPN for greater
than six months after stopping chemotherapy

- Average pain intensity >= 5 on 11-point numeric rating scale (NRS) in the lower
extremities at enrollment

- Failed conventional medication management with at least two neuropathic pain
medications

- Have electrophysiological evidence of length-dependent peripheral neuropathy

- Underwent a 10-kHz spinal cord stimulator trial for a primary indication of CIPN and
reported a successful trial of at least 75% reduction in pain intensity

- Have stable neurological status

- Be on a stable analgesic regimen

- Be an appropriate candidate for surgical procedures required in this study

- Be able to read and understand English-written questionnaires and sign an informed
consent form in English

- Be willing and capable of giving informed consent

- Be willing and able to complete study-related requirements, procedures, and visits

Exclusion Criteria:

- Patient refusal to be included in study

- Presence of lower limb mononeuropathy

- History of lower limb amputation or ulceration

- Presence of another painful condition that is unrelated to CIPN and that is not
intended to be treated in this study

- Body mass index (BMI) >= 40

- Omeprazole (OME) > 120 mg

- Progressive neurological disease (multiple sclerosis, chronic inflammatory
demyelinating polyneuropathy, rapidly progressive arachnoiditis, brain or spinal cord
tumor, central deafferentation syndrome, complex regional pain syndrome, acute
herniating disc, severe spinal stenosis)

- Certain comorbidities: coagulation/bleeding disorders, diminished capacity from
cardiac/pulmonary disease

- Obtaining another interventional procedure unrelated to SCS to treat limb pain

- Have ongoing metastatic malignant neoplasm or untreated local malignant neoplasm.
Included patients must be deemed as in remission per discretion of treating oncologist

- Have a life expectancy of less than one year

- Have untreated addiction or dependency to medications, alcohol, or illicit drugs

- Have active, disruptive, and/or unstable psychological or psychiatric disorder

Eligibility last updated 8/9/22. Questions regarding updates should be directed to the study team contact.