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OpenTrials
Completed

NCT Number: NCT07820657

EEG Theta Band Rhythm in SCS

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.

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Key information

Conditions

Chronic Neuropathic Pain

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Walton Centre NHS Foundation Trust

Liverpool, Merseyside, L97LJ, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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 with the final mode on, on day 11. At this point, trial shall be concluded as per normal practice.

Primary outcomes

  1. The reduction in theta (4-7 Hz) power

    Time frame: Up to day 11 following trial lead implementation

    Used to differentiate responders from non-responders

Secondary outcomes

  1. Spatial profile of EEG changes

    Time frame: Up to day 11 following trial lead implementation

    Used to predict patient suitability to an SCS modality

  2. reduction in short and mid latency amplitude on SSEP

    Time frame: Up to day 11 following trial lead implementation

    Used to predict patient suitability to an SCS modality

Sponsors and collaborators

Lead sponsor

Walton Centre NHS Foundation Trust

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Sep 15, 2026
Registry last updated
Sep 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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