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Clinical Trials/NCT06453759
NCT06453759
Recruiting
Not Applicable

Thalamic Recordings in Children Undergoing SEEG

Great Ormond Street Hospital for Children NHS Foundation Trust1 site in 1 country30 target enrollmentSeptember 1, 2025

Overview

Phase
Not Applicable
Intervention
Additional electrodes into bilateral anterior, centromedian and pulvinar thalamic nuclei
Conditions
Focal Epilepsy
Sponsor
Great Ormond Street Hospital for Children NHS Foundation Trust
Enrollment
30
Locations
1
Primary Endpoint
Single pulse electrical stimulation (SPES):
Status
Recruiting
Last Updated
2 months ago

Overview

Brief Summary

Stereoelectroencephalography (SEEG) forms a key part of the pre-surgical evaluation in children who may be candidates for epilepsy surgery. It can help delineate the location of the putative epileptogenic zone, guiding further treatments including resective, disconnective and ablative epilepsy surgery techniques. However, less than 35% of children undergoing SEEG end up becoming seizure free following further treatment.

Open and closed loop stimulation of thalamic nuclei via deep brain stimulation (DBS) and responsive neurostimulation (RNS) are emerging treatment options for epilepsy. Thalamic target nuclei vary between studies and there are currently no gold standard personalised methods for choosing a target. This stems from the limited systematic neurophysiological recordings from thalamic nuclei; investigators currently do not understand the ictal and interictal thalamic signatures of involvement in epilepsy and do not understand how functional connectivity can be altered within and between patients.

In this prospective study, the investigators aim to recruit 30 patients undergoing SEEG as part of their pre-surgical evaluation for drug resistant epilepsy at Great Ormond Street Hospital over a period of 3 years. Once recruited, the investigators will target 3 nuclei bilaterally in each patient - the anterior, centromedian and pulvinar nuclei - using additional SEEG electrodes. Following clinical recording, the investigators will conduct two stimulation experiments, the first using single pulse electrical stimulation to measure effective connectivity between the thalamus and cortical regions and the second to study the effects of simulated DBS currents on cortical local field potential signatures.

This study will lay the foundation for a personalised approach to thalamic neuromodulation for drug-resistant epilepsy by identifying neurophysiological biomarkers of thalamic involvement in epilepsy, paving the way for closed loop neuromodulation strategies that aim to optimise response using these biomarkers.

Registry
clinicaltrials.gov
Start Date
September 1, 2025
End Date
December 1, 2028
Last Updated
2 months ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • All children undergoing SEEG as part of their pre-surgical evaluation at GOSH
  • Participants/parents/legal guardian provide informed consent for inclusion

Exclusion Criteria

  • 1\) Lack of informed consent

Arms & Interventions

Thalamic SEEG

The centromedian, anterior and pulvinar nuclei on each side will be chosen as target for new electrodes.

Intervention: Additional electrodes into bilateral anterior, centromedian and pulvinar thalamic nuclei

Outcomes

Primary Outcomes

Single pulse electrical stimulation (SPES):

Time Frame: Hospital discharge (maximum one month from SEEG implantation)

We will systematically conduct SPES from all cortical and thalamic contacts and record responses in all other contacts. This measures the effective connectivity.

Ictal thalamic involvement

Time Frame: Hospital discharge (maximum one month from SEEG implantation)

Experienced neurophysiologists will assess, during ictal activity, whether each of the nuclei are involved in the seizure and, if so, the latency between first cortical contact onset and thalamic nucleus onset.

Epileptogenicity index

Time Frame: Hospital discharge (maximum one month from SEEG implantation)

We will quantify ictal involvement by measuring the epileptogenicity index in each nucleus.

Interictal power distribution

Time Frame: Hospital discharge (maximum one month from SEEG implantation)

To assess interictal signatures, we will assess power at different frequencies in the nuclei using the 'fitting oscillations \& one over f' (FOOOF) method.

Secondary Outcomes

  • Incidence of bleeding(Hospital discharge (maximum one month from SEEG implantation))

Study Sites (1)

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