Thalamic Recordings in Children Undergoing SEEG

Status Not yet recruiting

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06453759
Study type	Interventional
Source	Great Ormond Street Hospital for Children NHS Foundation Trust
Contact	Aswin Chari, PhD
Phone	07726780817
Email	aswin.chari.18@ucl.ac.uk
Status	Not yet recruiting
Phase	N/A
Start date	August 2024
Completion date	December 2027

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT02245061` - Cortical Excitability Assessment Using Paired Pulses	N/A
Terminated	`NCT05081518` - A Study of Lu AG06466 in Participants With Treatment Resistant Focal Epilepsy	Phase 1
Withdrawn	`NCT05481905` - ENACT: A Study of ENX-101 as Adjunctive Treatment in Patients With Focal Seizures	Phase 2
Completed	`NCT02208492` - The Effects on Cognitive Function of Levetiracetam (Keppra®) Compared to Carbamazepine (Tegretol®, Carmazepine®) as Monotherapy for Children With Partial Seizure; A Multicentric Randomized Controlled Study	Phase 4
Recruiting	`NCT04839601` - RNS System RESPONSE Study	N/A
Completed	`NCT02898935` - Improvement of the Accuracy of Spatial Representation of Invasive Exploratory Electrodes in Focal Epilepsy
Enrolling by invitation	`NCT05748236` - The Efficacy and Safety of Lamotrigine Versus Carbamazepine in Focal Epilepsy	Phase 4
Terminated	`NCT01724918` - Lacosamide IV and EEG/EKG (LIVE) Study	Phase 2
Completed	`NCT00855738` - A Prospective, Observational Study On The Effectiveness Of New Antiepileptic Drugs As First Bitherapy In The Daily Clinical Practice	Phase 4
Recruiting	`NCT06309966` - Study to Determine if BHV-7000 is Effective and Safe in Adults With Refractory Focal Onset Epilepsy	Phase 2/Phase 3
Not yet recruiting	`NCT06210022` - Cognitive Impairment in Drug-resistant and Drug-responsive Focal Cryptogenic Epilepsy
Completed	`NCT01311440` - Modified Atkins Diet Treatment for Adults With Drug-resistant Epilepsy	N/A
Terminated	`NCT03955432` - Long-term Cardiac Monitoring in Epilepsy	N/A
Recruiting	`NCT06132893` - A Study to Determine if BHV-7000 is Effective and Safe in Adults With Refractory Focal Onset Epilepsy	Phase 2/Phase 3
Recruiting	`NCT05100771` - Optimized Volumetry in Radiology: Interest in Pediatric Brain MRI in the Exploration of Focal Epilepsy
Recruiting	`NCT04879433` - Prospective Open-label Evaluation of Cenobamate Adjunctive Treatment of Adults With Refractory Focal Epilepsy
Active, not recruiting	`NCT03916848` - Novel Network Analysis of Intracranial Stereoelectroencephalography	N/A
Recruiting	`NCT05198882` - Clinical Evaluation of Interstitial Laser Thermal Therapy Under Continuous MRI Monitoring as a Minimally Invasive Treatment of Patients With Medically Unbalanced Partial Epilepsy	Phase 1
Recruiting	`NCT05981755` - Breathing Rescue for SUDEP Prevention	N/A
Recruiting	`NCT03457961` - Post-market Study of AMPA Receptor Antagonists for Epilepsy Patients in Hong Kong

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Thalamic Recordings in Children Undergoing SEEG — TRICS

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms