Actively Recruiting
A Prospective Observational Study Assessing Efficacy of 10-kHz Spinal Cord Stimulation for the Treatment of Chemotherapy-Induced Peripheral Neuropathy
Led by Mayo Clinic · Updated on 2026-02-02
20
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating how spinal cord stimulation (SCS) affects pain levels and quality of life in patients with chemotherapy-induced peripheral neuropathy (CIPN). CIPN is a nerve disorder caused by chemotherapy that leads to symptoms like pain, numbness, tingling, swelling, or muscle weakness, usually starting in the hands or feet and worsening over time. This study aims to measure the impact of SCS on pain reduction and neurological improvements in patients who have CIPN. Participants in this observational study receive spinal cord stimulation therapy and complete questionnaires at multiple points: baseline, 3 months, 6 months, and 12 months. The study measures include pain intensity, neurological assessments, perceived global change, satisfaction, health-related quality of life, sleep disturbance, and adverse events related to SCS therapy. The therapy is delivered as a 10-kHz spinal cord stimulator trial with a requirement of at least 75% pain reduction during the trial phase. During the study, patients complete 30-minute questionnaires at specified intervals to track changes in pain, neurological status, quality of life, and sleep issues. Researchers monitor for any adverse events and evaluate overall satisfaction with treatment. The main outcome is the percentage of patients experiencing at least a 50% reduction in lower extremity pain at 6 months, along with secondary assessments conducted up to 12 months. Participants are followed over time to assess both benefits and potential risks of SCS for CIPN.
CONDITIONS
Brief Title
Assessing Effect of Spinal Cord Stimulation on Pain and Quality of Life With Chemotherapy-Induced Peripheral Neuropathy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults 18 years or older clinically diagnosed with chemotherapy-induced peripheral neuropathy for more than six months after chemotherapy
- Average lower extremity pain intensity of 5 or higher on an 11-point numeric rating scale at enrollment
- Failed treatment with at least two neuropathic pain medications
- Electrophysiological evidence of length-dependent peripheral neuropathy
- Successful 10-kHz spinal cord stimulator trial with at least 75% reduction in pain
- Stable neurological status
- Stable analgesic regimen
- Suitable candidate for required surgical procedures
- Able to read and understand English and provide informed consent
- Willing and able to complete study-related procedures and visits
You will not qualify if you...
- Refusal to participate in the study
- Presence of lower limb mononeuropathy
- History of lower limb amputation or ulceration
- Painful conditions unrelated to chemotherapy-induced peripheral neuropathy
- Body mass index (BMI) of 40 or higher
- Omeprazole dosage over 120 mg
- Progressive neurological diseases such as multiple sclerosis or severe spinal stenosis
- Certain comorbidities including coagulation or bleeding disorders and severe cardiac or pulmonary disease
- Receiving other interventional procedures unrelated to spinal cord stimulation for limb pain
- Active metastatic or untreated local malignant neoplasm unless in remission
- Life expectancy less than one year
- Untreated addiction or dependency to medications, alcohol, or illicit drugs
- Active, disruptive, or unstable psychological or psychiatric disorders
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 months
Participants who receive spinal cord stimulation therapy complete questionnaires assessing pain, neurological status, quality of life, and sleep disturbance.
4 visits at baseline, 3 months, 6 months, and 12 months
Trial Site Locations
Total: 1 location
1
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Actively Recruiting
Research Team
C
Clinical Trials Referral Office
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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