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

Chemotherapy-induced Peripheral Neuropathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06162403
• Other study ID #: 2023-0368
• Secondary ID: NCI-2023-10303
• Status: Recruiting
• Phase: N/A
• Start date: February 22, 2024
• Est. completion date: December 31, 2024

Study information

• Verified date: June 2024
• Source: M.D. Anderson Cancer Center
• Contact: Saba Javed, MD
• Phone: (713) 792-9530
• Email: sjaved[@]mdanderson.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

• Pregnant participants

• Participants with conditions that conflict with the SPRINT PNS System Indications for Use, including Contraindications and Warnings.

Related Conditions & MeSH terms

• Chemotherapy-induced Peripheral Neuropathy
• Peripheral Nervous System Diseases

Intervention

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.

Locations

Country	Name	City	State
United States	MD Anderson Cancer Center	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and adverse events (AEs)	Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0	Through study completion; an average of 1 year.

External Links

•   MD Anderson Cancer Center