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EEG Theta Band Rhythm in SCS

NCT07820657 — Not applicable, Completed, 23 participants, Walton Centre NHS Foundation Trust

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Reversal of EEG Theta Rhythm as an Objective Measure of Efficacy of Spinal Cord Stimulation in Chronic Neuropathic Pain - a Pilot Study

RegistryNCT07820657
StatusCompleted
PhaseNot applicable
Study typeInterventional; na, single group, masking: none, treatment
Enrollment23 (Actual)
SponsorWalton Centre NHS Foundation Trust (Other)
ConditionsChronic Neuropathic Pain
InterventionsReversal in EEG Theta Power (Device)
Datesstart 2022-06-16, primary completion 2024-08-06, completion 2024-08-06, first posted 2026-09-15, last updated 2026-09-28
Locations1 site in United Kingdom

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-Summary

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.

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+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 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.

+Arms and interventions

ArmTypeInterventionsDescription
Reversal in EEG Theta power during trial periodExperimentalDevice: Reversal in EEG Theta Power
  • Reversal in EEG Theta Power (Device): 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 on day 11. At this point, trial shall be concluded as per normal practice.

+Outcome measures

Primary outcomes

  • The reduction in theta (4-7 Hz) power [Up to day 11 following trial lead implementation]: Used to differentiate responders from non-responders

Secondary outcomes

  • 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

+Eligibility

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

+Locations (1)

FacilityCityCountryStatus
The Walton Centre NHS Foundation TrustLiverpool, MerseysideUnited Kingdom

+Investigators

  • Deepti Bhargava, Principal investigator, Walton Centre NHS Foundation Trust

My Notes