Status:
NOT_YET_RECRUITING
Spinal Cord Stimulation for Chemotherapy Induced Peripheral Neuropathy
Lead Sponsor:
University of Maryland St. Joseph Medical Center
Conditions:
Chemotherapy-induced Peripheral Neuropathy
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Spinal Cord Stimulation using 10 kHz stimulation to the thoracic spinal cord will be a safe and effective treatment for CIPN, reducing pain in the lower extremities by at least 50%.
Eligibility Criteria
Inclusion
- CIPN as diagnosed by Oncology and/or neurology
- Receipt of a platinum-based or taxane chemotherapy prior to development of CIPN
- Pain severity greater than 4 out of 10 on a numeric rating scale of pain
- Pain chronicity greater than 6 months after the cessation of chemotherapy
- Failure of medical therapy, which must have included duloxetine
- Age 18 or greater
Exclusion
- Platelet count less than 100k/mm3
- Spinal anatomy precluding placement of the SCS leads between T6 and T11
- Active infection
- Estimated Lifespan less than 1 year
- Receipt of vincristine, thalidomide, bortezomib, or eribulin within the prior 12 months
Key Trial Info
Start Date :
September 15 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 15 2026
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT06596200
Start Date
September 15 2024
End Date
November 15 2026
Last Update
September 19 2024
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