Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
30 participants
INTERVENTIONAL
2025-09-01
2028-12-31
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
BASIC_SCIENCE
NONE
Study Groups
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Thalamic SEEG
The centromedian, anterior and pulvinar nuclei on each side will be chosen as target for new electrodes.
Additional electrodes into bilateral anterior, centromedian and pulvinar thalamic nuclei
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:
1. Single pulse electrical stimulation (SPES):
2. 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.
Interventions
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Additional electrodes into bilateral anterior, centromedian and pulvinar thalamic nuclei
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:
1. Single pulse electrical stimulation (SPES):
2. 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.
Eligibility Criteria
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Inclusion Criteria
2. Participants/parents/legal guardian provide informed consent for inclusion
Exclusion Criteria
2 Years
20 Years
ALL
No
Sponsors
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Great Ormond Street Hospital for Children NHS Foundation Trust
OTHER
Responsible Party
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Locations
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Great Ormond Street Hospital for Children
London, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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23BI31
Identifier Type: -
Identifier Source: org_study_id
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