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NCT Number: NCT06453759

Thalamic Recordings in Children Undergoing SEEG

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.

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Key information

Age range

2 year–20 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Great Ormond Street Hospital for Children

London, WC1N 3JH, United Kingdom

Location status: Recruiting

Location contact

Aswin Chari, PhD

CONTACT

[email protected]

07726780817

Who can participate

Healthy volunteers accepted: No

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

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

  • Lack of informed consent

Treatment and study plan

Additional electrodes into bilateral anterior, centromedian and pulvinar thalamic nuclei

Procedure

The centromedian, anterior and pulvinar nuclei on each side will be chosen as target for new electrodes; up to 6 additional electrodes may be added but, where possible, existing electrode trajectories will be extended to facilitate recording.

At the beginning of the recording process, usually within the first 24-48 hours of implantation, we will conduct 2 study-specific stimulation experiments:

  • Single pulse electrical stimulation (SPES):
  • N-of-1 trials of simulated DBS: We will simulate high (130Hz) and low (6Hz) frequency DBS currents from each pair of thalamic nuclei (always bilateral) and record spontaneous interictal neuronal activity in all other cortical contacts for 15 minutes. We will also record SPES from each of the cortical contacts.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Secondary outcomes

  1. Incidence of bleeding

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

    Radiological evidence of bleeding or clinically new neurological symptoms during SEEG implantation

Study contacts

Contact information is provided by the study sponsor or research team.

Aswin Chari, PhD

CONTACT

[email protected]

07726780817

Martin Tisdall, MD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Great Ormond Street Hospital for Children NHS Foundation Trust

Other

Registry information

Acronym: TRICS

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Jun 12, 2024
Registry last updated
Feb 2, 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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