Recruiting

Spinal Cord Stimulation

Sponsor:

Mayo Clinic

Code:

NCT05411523

Conditions

Chemotherapy-Induced Peripheral Neuropathy

Hematopoietic and Lymphoid System Neoplasm

Malignant Solid Neoplasm

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Quality-of-Life Assessment

Questionnaire Administration

Spinal Cord Stimulation

Study Details

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 of the potential side effects of chemotherapy that causes pain, numbness, tingling, swelling, or muscle weakness in different parts of the body. CIPN usually begins in the hands or feet and gets worse over time. SCS is a type of therapy that has proven to be effective in treating numerous non-malignant pain disorders including failed back surgery syndrome, refractory angina, limb ischemia, complex regional pain syndrome, and diabetic peripheral neuropathy. SCS may also be useful in patients with CIPN. This study evaluates how SCS affects pain and quality of life in patients undergoing spinal cord stimulation for CIPN.

Conditions

Chemotherapy-Induced Peripheral Neuropathy

Hematopoietic and Lymphoid System Neoplasm

Malignant Solid Neoplasm

Study ID

NCT05411523

Start date

Apr 14, 2022

Status verified date

Jul, 2026

Completion date

Apr 15, 2028

Anticipated

Primary completion date

Apr 15, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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 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

Study Design

Enrollment

20 participants

Anticipated

Interventions and Outcome Measures

Arms

Observational (spinal cord stimulation, questionnaires)

Patients receiving spinal cord stimulation therapy complete questionnaires over 30 minutes at baseline and at 3, 6, and 12 months.

Interventions

Quality-of-Life Assessment

Complete quality of life assessment

Questionnaire Administration

Complete questionnaires

Spinal Cord Stimulation

Receive spinal cord stimulation therapy

Primary outcome measure

  • Pain intensity [ Time Frame: At 6 months ]

Central Contacts and Locations

Central contacts

Clinical Trials Referral Office

855-776-0015mayocliniccancerstudies@mayo.edu

Locations

Mayo Clinic in Rochester

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Clinical Trials Referral Office

855-776-0015mayocliniccancerstudies@mayo.edu

Principal Investigator:

Ryan S. D'Souza, MD

More Information

Sponsor

Mayo Clinic

Last update posted

Jul 29, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2026-07-29.