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

Not Applicable

Not yet recruiting

• Conditions: Peripheral Neuropathy Due to Chemotherapy
• Interventions: Device: Spinal cord stimulator implant

• Registration Number: NCT06616649
• Lead Sponsor: M.D. Anderson Cancer Center

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.

Detailed Description

Primary Objective:

To explore the impact of using closed loop spinal cord stimulation (SCS) on pain control, quality of life, and pain medication use in patients suffering from chemotherapy induced peripheral neuropathy (CIPN).

Secondary Objective:

To assess the relationship between pain control from closed loop spinal cord stimulation and any associated changes in quantitative sensory testing (QST) and quantitative gait testing (QGT).

Study Timeline

• Status Verified: 2024-09
• Study First Submitted: 2024-09-25
• Study First Submitted QC: 2024-09-25
• Last Update Submitted: 2024-09-25
• Study First Posted: 2024-09-27
• Last Update Posted: 2024-09-27
• Study Start: 2025-03-01
• Primary Completion: 2025-07-01
• Study Completion: 2027-07-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• 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.

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
SCS Implantation	Spinal cord stimulator implant	Participants will be screened on a weekly basis in the Pain Management Clinic

Primary Outcome Measures

Name	Time	Method
Numerical Rating Scale (NRS)	Through study completion; an average of 1 year	These scales are 0-10 (0 being no pain \& 10 most extreme pain).

Trial Locations

Locations (1)

The University of Texas MD Anderson Cancer Center; 🇺🇸 Houston, Texas, United States