Ignite Creation Date:
2024-06-16 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06453759
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-12
First Post:
2024-05-24
Brief Title:
Thalamic Recordings in Children Undergoing SEEG
Sponsor:
Great Ormond Street Hospital for Children NHS Foundation Trust
Organization:
Great Ormond Street Hospital for Children NHS Foundation Trust
Study Overview
Official Title:
Thalamic Recordings in Children Undergoing SEEG
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TRICS
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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None