Patient Experience Comparing Tonic Vs. Burst Spinal Cord Stimulation For Chronic Pain

Mayo Clinic

Status: Terminated

Conditions: Chronic Pain

Treatments: Device: Spinal Cord Stimulator

Study type: Interventional

Funder types: Other

Identifiers

NCT04159753

19-001362

Details and patient eligibility

About

Researchers are evaluating if subjects who have already experienced tonic spinal cord stimulation would have a better pain relief status with burst spinal cord stimulation.

Full description

The study is a controlled trial with subjects that have an already-implanted SCS device (Eon Mini™) and are not satisfied with their pain relief status. As part of medical standard of care, patients with already-implanted Eon family tonic implantable pulse generators (IPGs) have the opportunity to experience burst stimulation for 30-Day Trial FDA approved. The aim of the study record patients experience during the 30-Day Trial using standard questionnaires.

Enrollment: 2 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Males and females ≥18 years-old
• Diagnosed with chronic pain
• Have an already-implanted Eon Family IPG for a minimum period of 6 months
• Are interested in trying burst technology by reprograming their IPG for 2-3 weeks according to the 30-Day Trial standard of care
• Signed informed consent

Exclusion criteria

• Subject's overall Beck Depression Inventory II Score is >24 or has a score of 3 on question 9 relating to suicidal thoughts or wishes at the screening visit; If subjects scores indicate suicidal thoughts, subject is going to be evaluated further if they will be subjects to Baker's act
• Subject is currently receiving, applying or considering seeking disability payments, workers compensation, or is involved in disability litigation
• Subject has an infusion pump or any other implantable neurostimulator device
• Subjects with a separate, concurrent, clinically significant or disabling chronic pain problem that requires additional medical or surgical treatment
• Subject's pain originates from peripheral vascular disease
• Subject is immunocompromised
• Subject has a documented history of substance abuse (narcotics, alcohol, etc.) or substance dependency in the 6 months prior to baseline data collection
• Subject has history of cancer requiring active treatment in the last 6 months
• Pregnancy

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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2 participants in 1 patient group

Spinal Cord Stimulator

Other group

Description:

Burst neurostimulation

Treatment:

Device: Spinal Cord Stimulator