Status:
RECRUITING
Assessing Effect of Spinal Cord Stimulation on Pain and Quality of Life With Chemotherapy-Induced Peripheral Neuropathy
Lead Sponsor:
Mayo Clinic
Conditions:
Chemotherapy-Induced Peripheral Neuropathy
Hematopoietic and Lymphoid System Neoplasm
Eligibility:
All Genders
18+ years
Brief Summary
This study examines how spinal cord stimulation (SCS) affects pain level and quality of life in patients experiencing chemotherapy-induced peripheral neuropathy (CIPN). CIPN is a nerve problem and one...
Detailed Description
PRIMARY OBJECTIVES: I. To measure percentage of responders who had at least 50% reduction in lower extremity pain at 6 months. II. To measure overall improvement in neurological assessment at 6 mont...
Eligibility Criteria
Inclusion
- Adult patients greater than or equal to 18 years of age 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
- 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
Key Trial Info
Start Date :
April 14 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
April 15 2027
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT05411523
Start Date
April 14 2022
End Date
April 15 2027
Last Update
September 5 2025
Active Locations (1)
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1
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905