NCT03419312

PET Patterns, Biomarkers and Outcome in Burst SCS Treated FBSS Patients

Cerebral PET Patterns, Inflammatory Biomarkers and Outcome in Patients Treated With Burst Spinal Cord Stimulation for Chronic Low Back and Leg Pain: A Randomized Controlled Clinical Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: Uppsala University · Academic / Other
• Sex: All
• Age: 18 Years – 59 Years
• Healthy volunteers: Not accepted

Summary

The primary aim of this study is to investigate cerebral mechanisms of burst stimulation in Failed Back Surgery Syndrome (FBSS) patients treated with Burst Spinal Cord Stimulation (SCS) for chronic back and leg pain. This study is a single center, prospective, blinded, randomized crossover trial with two 14 days treatment periods and two treatment arms (burst before sham stimulation or sham before burst stimulation).

Detailed description

Background and rationale: Tonic spinal cord stimulation for chronic primarily neuropathic pain har been used for over 50 years. Tonic stimulation in frequencies from 20 to 70 Hz produces analgesia and paresthesia in the targeted area. Burst stimulation, a novel spinal cord stimulation pattern, is an intermittent high frequency parenthesis-free therapy. This stimulation pattern consist of 5 spikes with an inter-spike frequency of 500 Hz, delivered at 40 Hz. Clinical effectiveness and noninferiority of Burst stimulation has been proved. A few studies suggest that Burst stimulation induce different activities in cerebral pathways, compared with tonic stimulation. Patient reported attention to pain assessed by the pain vigilance and awareness questionnaire (PVAQ) seems to differ between burst and tonic spinal cord stimulation. This trial is designed to investigate cerebral mechanisms of burst stimulation, using PET O15-water measured blood flow and tissue perfusion as a proxy for cerebral activity. Key events in study implementation: Study phase 1 * Study Inclusion and baseline visit. * Implantation of spinal cord stimulation system. Study phase 2: * Study visit 1(study day 0): Collection of Patient Reported Outcome Measurements (PROM) data, Randomization to study sequence, blood sampling, PET 0, programming of SCS-system. * Study visit 2 (study day 14): Blood sampling, PET 1, collection of PROM-data, SCS system switched off for washout. * Study visit 3 (study day 21): Collection of PROM-data, programming of SCS-system, blood sampling. * Study visit 4 (study day 35): Blood sampling, PET 2, collection of PROM-data, programming of SCS-system.

Conditions

• FBSS
• Pain, Intractable
• Low Back Pain
• Radicular; Neuropathic, Lumbar, Lumbosacral

Interventions

Type	Name	Description
DEVICE	Proclaim™ Elite 5: Burst - Washout - Sham	All implanted hardware manufactured by S:t Jude Medical/Abbot: Implantable Pulse Generator (IPG): Proclaim™ Elite 5 IPG, model 3660. Electrode: Octrode percutaneous lead, 60 cm, model 3161. Anchor: Long lead anchor, model 1106.
DEVICE	Proclaim™ Elite 5: Sham - Washout - Burst	All implanted hardware manufactured by S:t Jude Medical/Abbot: Implantable Pulse Generator (IPG): Proclaim™ Elite 5 IPG, model 3660. Electrode: Octrode percutaneous lead, 60 cm, model 3161. Anchor: Long lead anchor, model 1106.

Timeline

• Start date: 2018-02-11
• Primary completion: 2021-06-01
• Completion: 2021-06-01
• First posted: 2018-02-01
• Last updated: 2020-04-08

Locations

1 site across 1 country: Sweden