NCT06453759 Thalamic Recordings in Children Undergoing SEEG
| NCT ID | NCT06453759 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Great Ormond Street Hospital for Children NHS Foundation Trust |
| Condition | Focal Epilepsy |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2025-09-01 |
| Primary Completion | 2028-08 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 30 participants in total. It began in 2025-09-01 with a primary completion date of 2028-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion Criteria: 1. All children undergoing SEEG as part of their pre-surgical evaluation at GOSH 2. Participants/parents/legal guardian provide informed consent for inclusion Exclusion Criteria: 1\) Lack of informed consent
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06453759 clinical trial?
This trial is open to participants of all sexes, aged 2 Years or older, up to 20 Years, studying Focal Epilepsy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06453759 currently recruiting?
Yes, NCT06453759 is actively recruiting participants. Contact the research team at aswin.chari.18@ucl.ac.uk for enrollment information.
Where is the NCT06453759 trial being conducted?
This trial is being conducted at London, United Kingdom.
Who is sponsoring the NCT06453759 clinical trial?
NCT06453759 is sponsored by Great Ormond Street Hospital for Children NHS Foundation Trust. The trial plans to enroll 30 participants.
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