Chemotherapy-induced Peripheral Neuropathy, Peripheral Nerve Stimulation
Conditions
Brief summary
To learn if peripheral nerve stimulation (PNS) can help to improve pain in participants with CIPN.
Detailed description
Primary objective: To assess Pain intensity (NRS) scores in chemotherapy induced peripheral neuropathy (CIPN) participants before and after use of peripheral nerve stimulation (PNS). Secondary objectives: To assess changes in quantitative sensory testing (QST), gait testing, and skin punch biopsy to compare the integrity of Meissner's corpuscles (MC), pain disability using the Oswestry Disability Index (ODI), pain interference using the Brief Pain Inventory (BPI), and Patient Global Impression of Change (PGIC) in CIPN patients before and after use of PNS.
Interventions
OTHERPeripheral Nerve Stimulation
The leads are inserted through a needle. If needed, the study team may give participants anesthetic (for example, as a cream/gel on your skin and/or as an injection) to numb the area where the leads will be injected.
Sponsors
M.D. Anderson Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Participants diagnosed with chronic (≥90 days duration) CIPN (due to either vinca alkaloids, taxanes, bortezomib, thalidomide, platinum-based compounds or ionizing irradiation) of the lower extremity, seen at Pain Management Center at MD Anderson Cancer Center * Participants reports baseline pain ≥ 4 (0-10 scale, NRS) * Participants between ages 18-85 years old * Participants who have completed chemotherapy within the previous year at the time of enrollment
Exclusion criteria
* Participants with cognitive dysfunction * Participants with recent history (\<6 months) of drug or alcohol abuse * Participants with open skin lesion or undergoing antibiotic therapy for local for systemic infection * Participants with allergies to local anesthesia, steroids, or adhesives * Participants with conditions that conflict with the SPRINT PNS System Indications for Use, including Contraindications and Warnings.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety and adverse events (AEs) | Through study completion; an average of 1 year. | Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0 |
Countries
United States
Contacts
CONTACTSaba Javed, MD
PRINCIPAL_INVESTIGATORSaba Javed, MD
M.D. Anderson Cancer Center
Outcome results
None listed