Chronic Neuropathic Pain
Conditions
Keywords
EEG Theta Band Rhythm, Spinal Cord Stimulation, EEG, Chronic Neuropathic Pain
Brief summary
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 the changes in EEG pattern during trial with three modalities can help in selection of SCS modality best suited to a given patient.
Detailed description
The aim of the study is to see if reversal in EEG theta power during trial period can predict a sustained response (At 6 months post implantation) and thus serve as a n objective measure for SCS efficacy in a given patient- thus objectively identifying true responders. Additionally, this study aims to see if spinal 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.
Interventions
DEVICEReversal in EEG Theta Power
32 lead EEG at baseline, on day of surgery prior to trial lead implementation. Stimulation shall be started with high frequency and burst modes in alternate patients. First follow up EEG shall be performed with stimulation on day 3. Stimulation will then be switched over to the low frequency mode and a further EEG on this mode will be obtained on day 7. After this the third mode shall be tried and further EEG obtained with the final mode on, on day 11. At this point, trial shall be concluded as per normal practice.
Sponsors
Walton Centre NHS Foundation Trust
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adults (Aged 18 years or above and able to consent) with failed back surgery syndrome leading to neuropathic leg/back pain deemed suitable for spinal cord stimulation trial
Exclusion criteria
* Patients with history of epilepsy or epileptiform disorders
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The reduction in theta (4-7 Hz) power | Up to day 11 following trial lead implementation | Used to differentiate responders from non-responders |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Spatial profile of EEG changes | Up to day 11 following trial lead implementation | Used to predict patient suitability to an SCS modality |
| reduction in short and mid latency amplitude on SSEP | Up to day 11 following trial lead implementation | Used to predict patient suitability to an SCS modality |
Countries
United Kingdom
Contacts
PRINCIPAL_INVESTIGATORDeepti Bhargava
Walton Centre NHS Foundation Trust
Outcome results
None listed