EEG as objective measure of SCS efficacy
Research type
Research Study
Full title
Reversal of EEG theta rhythm as an objective measure of efficacy of spinal cord stimulation in chronic neuropathic pain- a pilot study
IRAS ID
283335
Contact name
Deepti Bhargava
Contact email
Sponsor organisation
Walton Centre NHS Foundation Trust
Clinicaltrials.gov Identifier
not applicable, not applicable
Duration of Study in the UK
1 years, 0 months, 1 days
Research summary
Chronic neuropathic pain after back surgery (FBSS) affects 5,800 /hundred thousand population in UK. Spinal cord stimulation(SCS) is standard treatment for medically refractory FBSS. Only 60-70% patients respond to SCS, requiring a trial prior to permanent implantation. However, only 50-70% of these responding patients (true responders) maintain a sustained clinical benefit. There is no objective tool to identify true responders. Also, there are three modalities for delivery of spinal cord stimulation. There is no objective tool to assess which modality might be best suited to a given patient.
Electroencephalogram(EEG), a non-invasive test, records brain rhythm. Thalamocortical Dysrhythmia with increased theta activity (a pattern of brain activity) in EEG has been recognized as a signature of chronic pain, reversible with effective treatment.
We want to assess if reversal in EEG theta power during trial phase can serve as an objective marker for sustained clinical response, identifying true responders, and if spatial profile of baseline EEG abnormality as well as EEG response to a given SCS modality during trial period, alongside clinical correlation, can help in selection of SCS modality best suited to a given patient.
We propose to undertake a prospective study of 40 patients (inclusion- consecutive patients, exclusion- epilepsy) undergoing trial of SCS at our centre. Consenting patients shall undergo a baseline EEG prior to commencement of trial, 3 further EEGs during trial – each after a period of stimulation with a specific modality and a final EEG 6 months after permanent implantation. Rest of the treatment will be standard.
Data will be processed in EEGlab, FieldTrip and sLoreta programmes. Statistical analysis for repeated measures ANOVA test will be evaluated in SPSS.
Primary outcome measure is reduction in theta (4-7 Hz) power (to differentiate responders from non- responders).
Secondary outcome measure is spatial profile of EEG changes (to predict patient suitability to an SCS modality).REC name
HSC REC B
REC reference
21/NI/0132
Date of REC Opinion
27 Jul 2021
REC opinion
Favourable Opinion