Exploring the Benefit of Peripheral Nerve Stimulation in Treating Pain From Chemo-induced Peripheral Neuropathy: A Longitudinal Single Center Feasibility Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Peripheral Nerve Stimulation.
- Who it may be relevant to
- Registry conditions: Peripheral Nerve Stimulation, Chemotherapy-induced Peripheral Neuropathy. Basic parameters: 18 years — 85 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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
- 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.
Primary outcome measures
- Safety and adverse events (AEs) [Time frame: Through study completion; an average of 1 year.]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
United States · 1 center
- MD Anderson Cancer Center — Houston
Identifiers
NCT: NCT06162403 · 2023-0368 · NCI-2023-10303