Exploring the Benefit of Peripheral Nerve Stimulation in Treating Pain From Chemo-induced Peripheral Neuropathy: A Longitudinal Single Center Feasibility Study

Purpose

To learn if peripheral nerve stimulation (PNS) can help to improve pain in participants with CIPN.

Conditions

  • Peripheral Nerve Stimulation
  • Chemotherapy-induced Peripheral Neuropathy

Eligibility

Eligible Ages
Between 18 Years and 85 Years
Eligible Sex
All
Accepts 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.

Study Design

Phase
N/A
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Supportive Care
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Peripheral Nerve Stimulation 		Participants will be asked to have PNS leads inserted via a needle, which will provide a mild, stimulating electrical current to the effected nerves 24 hours a day for up to 60 days. Participants will have study visits during and after this time.
  • Other: Peripheral 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.

Recruiting Locations

MD Anderson Cancer Center
Houston, Texas 77030
Contact:
Saba Javed, MD
713-792-9530
sjaved@mdanderson.org

More Details

Status
Recruiting
Sponsor
M.D. Anderson Cancer Center

Study Contact

Saba Javed, MD
(713) 792-9530
sjaved@mdanderson.org

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.