Epilepsy Intractable Clinical Trial
Official title:
Multicenter Comparison of Interictal High Frequency Oscillations as a Predictor of Seizure Freedom
In drug-resistant focal epilepsy, interictal high frequency oscillations (HFO) recorded from intracranial EEG (iEEG) may provide clinical information for delineating epileptogenic brain tissue. The iEEG electrode contacts that contain HFO are hypothesized to delineate the epileptogenic zone; their resection should then lead to postsurgical seizure freedom. We test whether our prospective definition of clinically relevant HFO is in agreement with postsurgical seizure outcome. The algorithm is fully automated and is equally applied to all datasets. The aim is to assess the reliability of the proposed detector and analysis approach.
We use an automated data-independent prospective definition of clinically relevant HFO that has been validated in data from two independent epilepsy centers. In this study, we combine retrospectively collected datasets from 9 independent epilepsy centers. The analysis is blinded to clinical outcome. We use iEEG recordings during NREM sleep with a minimum of 12 epochs of 5 minutes of NREM sleep. We automatically detect HFO in the ripple (80-250 Hz) and in the fast ripple (250-500 Hz) band. There is no manual rejection of events in this fully automated algorithm. The type of HFO that we consider clinically relevant is defined as the simultaneous occurrence of a fast-ripple and a ripple. We calculate the temporal consistency of each patient's HFO rates over several data epochs within and between nights. Patients with temporal consistency < 50% are excluded from further analysis. We determine whether all electrode contacts with high HFO rate are included in the resection volume and whether seizure freedom (ILAE 1) was achieved at ≥2 y follow-up. Applying a previously validated algorithm to a large cohort from several independent epilepsy centers may advance the clinical relevance and the generalizability of HFO analysis as essential next step for use of HFO in clinical practice. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03014752 -
Comparison of the Effectiveness of the Outpatient Classical Ketogenic Diet and Modified Atkins Diet on Seizures Frequency, Nutritional Status and Some Biochemical Factors in Children and Adolescents With Intractable Epilepsy
|
Phase 2/Phase 3 | |
Terminated |
NCT03790436 -
Betaquik as an Adjunct to Dietary Management of Epilepsy in Adults on the Modified Atkins Diet
|
N/A | |
Completed |
NCT05503511 -
Safety and Pharmacokinetic Study of NPT 2042 Soft-gelatin Capsules Administered Orally to Healthy Adult Subjects
|
Phase 1 | |
Enrolling by invitation |
NCT04286776 -
Memory Retrieval and Encoding Investigated by Neural Stimulation
|
N/A | |
Completed |
NCT04763070 -
Ciprofloxacin in Drug-resistant Epilepsy
|
N/A | |
Completed |
NCT03403907 -
The Effect of Probiotic Supplementation in Drug-resistant Epilepsy Patients
|
N/A | |
Recruiting |
NCT04158531 -
REC2Stim as a Treatment for Refractory Epilepsy in the Primary Sensorimotor Cortex.
|
N/A | |
Recruiting |
NCT03289572 -
Microgrid II - Electrocorticography Signals for Human Hand Prosthetics
|
||
Recruiting |
NCT04325360 -
Effects of Transcranial Direct Current Stimulation (tDCS) for the Treatment of Refractory Epilepsy
|
N/A | |
Active, not recruiting |
NCT05727943 -
Add-on Clioquinol in Drug-resistant Childhood Epilepsy: an Exploratory Study
|
Phase 2 | |
Recruiting |
NCT04649008 -
Localizing Epileptic Networks Using MRI and iEEG
|
Early Phase 1 | |
Active, not recruiting |
NCT03916848 -
Novel Network Analysis of Intracranial Stereoelectroencephalography
|
N/A | |
Completed |
NCT03646240 -
ABI-009 (Nab-rapamycin) for Surgically-Refractory Epilepsy (RaSuRE)
|
Phase 1 | |
Recruiting |
NCT03857074 -
Effects of Green Light Exposure on Epileptic Spikes in Patients With Refractory Epilepsy
|
N/A | |
Enrolling by invitation |
NCT03702127 -
TMS - Intracranial Electrodes
|
N/A | |
Recruiting |
NCT05015868 -
Contribution of Genetics, Non-invasive Methods and Neuropsychology in Focal Cryptogenic Epilepsies
|
N/A | |
Enrolling by invitation |
NCT06138808 -
5-SENSE Score Validation Study
|
||
Not yet recruiting |
NCT03741192 -
Impact of SPEAC® System Data on Therapeutic Decisions Related to Convulsive Seizure Patient's Refractory to AEDs
|
N/A | |
Enrolling by invitation |
NCT05248269 -
Thermocoagulation in Drug Resistant Focal Epilepsy
|
N/A | |
Completed |
NCT04399954 -
Evaluation of Ketoflo
|
N/A |