Electroencephalographic changes in spinal cord stimulation therapy
Research type
Research Study
Full title
A prospective randomised, single blind, cross over study to evaluate EEG changes in patients’ undergoing Spinal Cord Stimulation(SCS) with high frequency and burst frequency for Failed Back Surgery Syndrome(FBSS).
IRAS ID
203835
Contact name
Ganesan Baranidharan
Contact email
Sponsor organisation
Research Governance manager LTHT
Duration of Study in the UK
1 years, 0 months, 1 days
Research summary
TITLE -A prospective randomised, single blind, cross over study to evaluate EEG changes in patients’ undergoing Spinal Cord Stimulation(SCS)with high frequency and burst frequency for Failed Back Surgery Syndrome(FBSS).
SCS is stimulation by means of an electrode in the back and 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 7-10 day cycle of high frequency and 7-10 day cycle 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 Neuromodulation centre and the EEG analysis will be done by a research team based in Belgium (Brain Lab.
We hope that the study will improve our understanding of how different stimulation waveforms used for spinal cord stimulation work. We hope to have recruited all 20 patients in a 12 month period.
REC name
North East - York Research Ethics Committee
REC reference
17/NE/0006
Date of REC Opinion
27 Jan 2017
REC opinion
Further Information Favourable Opinion