NCT03582059

Electroencephalographic Changes in Spinal Cord Stimulation

A Prospective, Double Blind, Cross Over, Pilot Study to Evaluate EEG Changes in Patients' Undergoing Spinal Cord Stimulation(SCS) With High Frequency and Burst Frequency for Failed Back Surgery Syndrome(FBSS).

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: The Leeds Teaching Hospitals NHS Trust · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

Spinal cord stimulation by means of an electrode in the back is used to treat patients with persistent chronic pain after back surgery. Based on the stimulation patterns, there are mainly three different technologies available - conventional, burst frequency and the high frequency. It is known that the traditional frequency works through the lateral system of pain pathways in the spinal cord to cause pain reduction. Electroencephalographic(tracing of brain activity) recording of patients using burst have shown an additional effect on an adjacent medial pain pathway which decreases the attention to pain. We want to therefore find out if high frequency stimulation also has an effect on the same pathways. 20 patients who have persistent neuropathic chronic pain after previous spinal surgery, would be eligible to have this treatment as part of their normal care. They will be randomly chosen to undergo a 2 week cycle of high frequency and 2 weeks of burst stimulation. We will record EEG's, pain scores and scores measuring attention to pain and compare findings. All patients will be recruited at the Leeds Pain and Neuromodulaton centre and the EEg analysis will be done by a research team based in Belgium. We hope that the study will improve our understanding of how different stimuation waveforms used for spinal cord stimulation work. We hope to have recruited all 20 patients in a 12 month period.

Conditions

• Pain Management

Interventions

Type	Name	Description
PROCEDURE	High Frequency Spinal cord stimulation	An electrode will be implanted into the patients back. A defined stimulation patter will be applied. The patient will be randomised to received 7-10 days of high frequency stimulation.
PROCEDURE	Burst Frequency Spinal cord stimulation	An electrode will be implanted into the patients back. A defined stimulation patter will be applied. The patient will be randomised to received 7-10 days of burst frequency stimulation.

Timeline

• Start date: 2017-04-01
• Primary completion: 2018-10-16
• Completion: 2019-12-01
• First posted: 2018-07-10
• Last updated: 2019-08-13

Locations

1 site across 1 country: United Kingdom