Reversal of EEG Theta Rhythm as an Objective Measure of Efficacy of Spinal Cord Stimulation in Chronic Neuropathic Pain - a Pilot Study
| Registry | NCT07820657 |
|---|---|
| Status | Completed |
| Phase | Not applicable |
| Study type | Interventional; na, single group, masking: none, treatment |
| Enrollment | 23 (Actual) |
| Sponsor | Walton Centre NHS Foundation Trust (Other) |
| Conditions | Chronic Neuropathic Pain |
| Interventions | Reversal in EEG Theta Power (Device) |
| Dates | start 2022-06-16, primary completion 2024-08-06, completion 2024-08-06, first posted 2026-09-15, last updated 2026-09-28 |
| Locations | 1 site in United Kingdom |
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The investigators 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.
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 an 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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Reversal in EEG Theta power during trial period | Experimental | Device: Reversal in EEG Theta Power |
Sex: All, ages: 18 Years to any
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
| Facility | City | Country | Status |
|---|---|---|---|
| The Walton Centre NHS Foundation Trust | Liverpool, Merseyside | United Kingdom |