Closed-loop spinal cord stimulation to reduce pain from chemotherapy-induced peripheral neuropathy
Closed Loop Spinal Cord Stimulation for Chemotherapy Induced Peripheral Neuropathy, a Pilot Study.
This trial will try a closed-loop spinal cord stimulator to reduce pain and improve walking and sensation in adults with painful chemotherapy-induced peripheral neuropathy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | M.D. Anderson Cancer Center Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy |
| Locations | 1 site (Houston, Texas) |
| Trial ID | NCT06616649 on ClinicalTrials.gov |
What this trial studies
This is a single-center pilot interventional study at MD Anderson testing an implanted closed-loop spinal cord stimulator in adults with lower-extremity chemotherapy-induced peripheral neuropathy (CIPN). Participants will receive an SCS implant and be followed for changes in pain, quality of life, and pain medication use. The study also collects objective measures of sensation (quantitative sensory testing) and gait (quantitative gait testing) to look for associated functional and sensory improvements. Patients on active chemotherapy or with conditions that could interfere with safety or outcome measurement are excluded.
Who should consider this trial
Good fit: Adults (≥18) with a history of painful lower-extremity CIPN who are medically stable, not receiving active chemotherapy or investigational agents, and able to consent and attend implant and follow-up visits are the intended participants.
Not a fit: Patients actively receiving chemotherapy or immunotherapy, those with prior non-CIPN sensorimotor neuropathies, brain metastases, active infections, pregnancy, or conditions limiting follow-up are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, closed-loop SCS could meaningfully reduce chronic CIPN pain, decrease reliance on pain medicines, and improve sensation and walking ability.
How similar studies have performed: Spinal cord stimulation has shown benefit for some neuropathic pain conditions in prior studies, but closed-loop SCS specifically for CIPN is relatively novel and has limited prior data.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥18 years * Diagnosis history of CIPN of lower extremities * Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of SCS * Ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria: * Patients undergoing active chemotherapy or immunotherapy * Patients undergoing medical litigation. * Patients with active infection, being treated with antibiotics * Patients that are pregnant or planning to conceive * Patients who are receiving any investigational agents. * Patients with brain metastases. * Patients with cognitive impairment/psychiatric illness/social situations that would limit compliance with study requirements. * Patients with history of alternative forms of sensorimotor neuropathies prior to CIPN presentation
Where this trial is running
Houston, Texas
- The University of Texas MD Anderson Cancer Center — Houston, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Matthew Chung, MD — M.D. Anderson Cancer Center
- Study coordinator: Matthew Chung, MD
- Email: mchung1@mdanderson.org
- Phone: 713-792-9806
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.