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

M.D. Anderson Cancer Center

Status: Not yet enrolling

Conditions: Peripheral Neuropathy Due to Chemotherapy

Treatments: Device: Spinal cord stimulator implant

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06616649

2024-0446

Details and patient eligibility

About

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.

Full 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).

Enrollment: 10 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

SCS Implantation

Experimental group

Description:

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

Treatment:

Device: Spinal cord stimulator implant