Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06521437
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
None
First Post:
2024-07-08
Brief Title:
Hippocampal Network Function in Epilepsy
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Hippocampal Network Function in Epilepsy
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The aim of this pilot study is to understand hippocampal network function in mesial temporal lobe epilepsy MTLE and to test whether transcranial magnetic stimulation TMS targeting the network of the hippocampus can change hippocampal-dependent memory task performance and epileptic activity in people with MTLE Positive findings would implicate the hippocampal network as a source of these typical primary MTLE symptoms
Subjects with a primary diagnosis of MTLE will be enrolled in a non-randomized non-blinded pilot experiment to test target engagement and preliminary efficacy of a novel neurostimulation approach targeting the hippocampal network At baseline subjects will undergo neurocognitive testing for hippocampal-dependent memory and functional magnetic resonance imagining fMRI neuroimaging assessment of brain structure and task-dependent activity They will also receive scalp-electroencephalography EEG to measure interictal epileptiform discharge IED frequency at baseline and will complete a seizure diary for one month They will then receive high-frequency repetitive TMS targeting an area of parieto-occipital cortex defined based on fMRI connectivity with the hippocampus measured at baseline The baseline assessments will then be repeated using an alternate form of the memory test The investigators will analyze changes from baseline in memory task performance fMRI activity of the hippocampal network IED frequency and reported seizure frequency
Subjects with a primary diagnosis of MTLE will be enrolled in a non-randomized non-blinded pilot experiment to test target engagement and preliminary efficacy of a novel neurostimulation approach targeting the hippocampal network At baseline subjects will undergo neurocognitive testing for hippocampal-dependent memory and functional magnetic resonance imagining fMRI neuroimaging assessment of brain structure and task-dependent activity They will also receive scalp-electroencephalography EEG to measure interictal epileptiform discharge IED frequency at baseline and will complete a seizure diary for one month They will then receive high-frequency repetitive TMS targeting an area of parieto-occipital cortex defined based on fMRI connectivity with the hippocampus measured at baseline The baseline assessments will then be repeated using an alternate form of the memory test The investigators will analyze changes from baseline in memory task performance fMRI activity of the hippocampal network IED frequency and reported seizure frequency
Detailed Description:
The purpose of this pilot study is to investigate hippocampal network dysfunction associated with mesial temporal lobe epilepsy MTLE and to examine whether network-targeted transcranial magnetic stimulation TMS can affect hippocampal connectivity cognitive performance and epileptic activity observed in adult subjects with MTLE
Subjects will be recruited through the University of Chicago Medicine Comprehensive Epilepsy Center and other local epilepsy centers Subjects will complete up to 8 experimental sessions 1 baseline experimentassessment up to 5 TMS sessions up to 2 post-treatment experimentsassessments spread over a two-month period During the baseline and post-treatment sessions subjects will undergo electroencephalography EEG and functional magnetic resonance imaging fMRI EEG will be utilized to examine interictal epileptiform discharge IED frequency at rest as well as task-related neural activity recorded from non-invasive scalp EEG electrodes at locations conforming to the International 10-20 positioning system with additional anterior temporal electrodes MRI scanning procedures will take approximately 45 minutes and include native anatomical MP-RAGE as well as functional EPI sequences to assess hippocampal network function and task-related activity During both the EEG and MRI procedures subjects will perform a memory task
One month following the baseline session subjects will return to the lab for up to 5 TMS intervention sessions During the one-month period preceding TMS subjects will complete a daily seizure diary to track baseline seizure frequency prior to the intervention TMS parameters are determined based on the allowable dosage of TMS delivery calculated based on published standards for experimental TMS protocols and in accordance with standard operating procedures for TMS Subjects will receive brief 2 to 40s trains of repetitive TMS with long 10s inter-train intervals Each train of repetitive TMS will include between 20 and 40 individual pulses delivered at frequencies hypothesized to have different effects on memory eg in the theta range Individual pulse intensity will be calibrated using the motor-threshold method Post-treatment sessions will once again comprise EEG and fMRI procedures as described above Following the post-treatment sessions subjects will continue to complete a daily seizure diary for the next 30 days to track any changes to seizures following treatment Pre- and post-stimulation data will be compared to assess effects of the intervention on memory performance hippocampal network function and epileptic activity
Subjects will be recruited through the University of Chicago Medicine Comprehensive Epilepsy Center and other local epilepsy centers Subjects will complete up to 8 experimental sessions 1 baseline experimentassessment up to 5 TMS sessions up to 2 post-treatment experimentsassessments spread over a two-month period During the baseline and post-treatment sessions subjects will undergo electroencephalography EEG and functional magnetic resonance imaging fMRI EEG will be utilized to examine interictal epileptiform discharge IED frequency at rest as well as task-related neural activity recorded from non-invasive scalp EEG electrodes at locations conforming to the International 10-20 positioning system with additional anterior temporal electrodes MRI scanning procedures will take approximately 45 minutes and include native anatomical MP-RAGE as well as functional EPI sequences to assess hippocampal network function and task-related activity During both the EEG and MRI procedures subjects will perform a memory task
One month following the baseline session subjects will return to the lab for up to 5 TMS intervention sessions During the one-month period preceding TMS subjects will complete a daily seizure diary to track baseline seizure frequency prior to the intervention TMS parameters are determined based on the allowable dosage of TMS delivery calculated based on published standards for experimental TMS protocols and in accordance with standard operating procedures for TMS Subjects will receive brief 2 to 40s trains of repetitive TMS with long 10s inter-train intervals Each train of repetitive TMS will include between 20 and 40 individual pulses delivered at frequencies hypothesized to have different effects on memory eg in the theta range Individual pulse intensity will be calibrated using the motor-threshold method Post-treatment sessions will once again comprise EEG and fMRI procedures as described above Following the post-treatment sessions subjects will continue to complete a daily seizure diary for the next 30 days to track any changes to seizures following treatment Pre- and post-stimulation data will be compared to assess effects of the intervention on memory performance hippocampal network function and epileptic activity
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None