Spinal Cord Stimulation for Chemotherapy Induced Peripheral Neuropathy

University of Maryland St. Joseph Medical Center

Status and phase: Not yet enrolling; Phase 4

Conditions: Chemotherapy-induced Peripheral Neuropathy

Treatments: Device: Spinal Cord Stimulation Implant

Study type: Interventional

Funder types: Other

Identifiers

NCT06596200

00110894

Details and patient eligibility

About

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%.

Enrollment: 10 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Intervention Group - SCS

Experimental group

Description:

Patients who are eligible will receive a trial implant for a 3-7 day trial period. If there is at least 50% pain relief in the trial period, the patients will receive the permanent SCS implant and will be followed for 1 year post permanent implant.

Treatment:

Device: Spinal Cord Stimulation Implant