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Spinal Cord Stimulation for Chemotherapy-Induced Peripheral Neuropathy

This observational study is looking at how spinal cord stimulation (SCS) affects pain and quality of life for people with chemotherapy-induced peripheral neuropathy (CIPN). CIPN is a nerve problem that can cause pain, numbness, and tingling after chemotherapy. SCS is a therapy that has helped with other pain conditions, and researchers want to see if it can help with CIPN. To join, you must be an adult (18 or older) with a CIPN diagnosis for over six months, have average pain of 5 or higher on an 11-point scale in your lower legs, and have not found relief with at least two other pain medications. The main goal is to see if SCS can reduce lower extremity pain by at least 50% after 6 months.

Study design
This is an observational study with 20 participants. It is not specified if it is randomized or blinded.
What's involved
If you participate, you will receive spinal cord stimulation therapy and complete questionnaires at the start, and then at 3, 6, and 12 months. Each questionnaire session will take about 30 minutes.
Compensation
Not stated in the trial record.
Follow-up
Participants are followed for 12 months after starting the study.

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NCT05411523

Assessing Effect of Spinal Cord Stimulation on Pain and Quality of Life With Chemotherapy-Induced Peripheral Neuropathy

Recruiting
Not specifiedAges 18+Observational
Mayo Clinic
~20 participants
Updated 2026-07-29 on ClinicalTrials.gov
What's tested:Quality-of-Life AssessmentQuestionnaire AdministrationSpinal Cord Stimulation

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Pain intensity
Measured over At 6 months

Conditions

Chemotherapy-Induced Peripheral Neuropathy
Hematopoietic and Lymphoid System Neoplasm
Malignant Solid Neoplasm

Explore related trials

Chemotherapy-Induced Peripheral NeuropathyHematopoietic and Lymphatic System NeoplasmSolid Neoplasm

Where it's being run

1 sites across 1 states
Minnesota1

Study leadership

  • Ryan S. D'Souza, MD · PRINCIPAL_INVESTIGATOR · Mayo Clinic in Rochester

Who to contact

Clinical Trials Referral Office
[email protected]
855-776-0015
Email the study team

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Do you actually qualify for this trial?

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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

What this trial measures

  • Pain intensityAt 6 months

    Percentage of patients who experience \>= 50% improvement of pain intensity on numeric rating scale score at 6 months compared to baseline. Paired t-test test will be carried out to compare questionnaire scores between each follow-up time point and baseline. All p-values will be reported as two-sided. Statistical Packages for Social Sciences (SPSS) software will be used for statistical analysis.