Closed Loop Spinal Cord Stimulation for Chemotherapy Induced Peripheral Neuropathy, a Pilot Study.

NCT06616649 | Recruiting FDA Device

• 2 other identifiers: 2024-0446NCI-2024-08285
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

To explore the benefits of using closed loop spinal cord stimulation (SCS) in the treatment of patients experiencing painful chemotherapy induced peripheral neuropathy (CIPN) by assessing changes in pain, quality of life, pain medication use, sensory improvement through quantitative sensory testing, and improvement of gait through quantitative gait testing.

Conditions

Peripheral Neuropathy Due to Chemotherapy

Outcome Measures

Primary Outcomes (1)

• Numerical Rating Scale (NRS)

  These scales are 0-10 (0 being no pain \& 10 most extreme pain).

  Through study completion; an average of 1 year

Study Arms (1)

SCS Implantation

EXPERIMENTAL

Participants will be screened on a weekly basis in the Pain Management Clinic

Device: Spinal cord stimulator implant

Interventions

Spinal cord stimulator implant DEVICE

Participants will receive intervention in the operating room setting

SCS Implantation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years
• Diagnosis history of CIPN of lower extremities
• Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of SCS
• Ability to understand and the willingness to sign a written informed consent document.

You may not qualify if:

• Patients undergoing active chemotherapy or immunotherapy
• Patients undergoing medical litigation.
• Patients with active infection, being treated with antibiotics
• Patients that are pregnant or planning to conceive
• Patients who are receiving any investigational agents.
• Patients with brain metastases.
• Patients with cognitive impairment/psychiatric illness/social situations that would limit compliance with study requirements.
• Patients with history of alternative forms of sensorimotor neuropathies prior to CIPN presentation

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• Saluda Medical Pty Ltd: collaborator

Study Sites (1)

The University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Related Links

• MD Anderson Cancer Center Website

Study Officials

• Matthew Chung, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Matthew Chung, MD

CONTACT

713-792-9806; mchung1@mdanderson.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 25, 2024
• First Posted: September 27, 2024
• Study Start: July 14, 2025
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: April 30, 2026

Record last verified: 2026-04

Locations

US (1)