Epilepsy, Drug Resistant
Conditions
Keywords
Deep Brain Stimulation, Drug Resistant Epilepsy, Piriform cortex, Temporal lobe epilepsy with bilateral hippocampal sclerosis, Neuromodulation
Brief summary
The primary objective of this research is to study the efficacy and safety of deep brain stimulation (DBS) of Piriform cortex as adjunctive therapy for reducing the frequency of seizures in drug-resistant temporal lobe epilepsy with bilateral hippocampal sclerosis
Detailed description
This project aims to include 5 participants, and evaluate the effectiveness and safety of piriform cortex stimulation in patients with temporal lobe epilepsy and bilateral hippocampal sclerosis through A prospective, interventional, unblinded, single-arm clinical trial. It is expected to provide new therapeutic options for patients with temporal lobe epilepsy and bilateral hippocampal sclerosis with alternative treatment options.
Interventions
DEVICEpiriform cortex-DBS
The surgical intervention named deep brain stimulation is a well-established neurosurgical treatment for drug-resistant epilepsy.The targets used in this study are biliteral piriform cortex.The devices used for intervention have been approved by Chinese National Medical Products Administration (CFDA). The postoperative drug dosage adjustment depends on the efficacy of DBS and the judgment of the epilepsy specialist.
Sponsors
Xuanwu Hospital, Beijing
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
14 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Participants are between the ages of 14 -65 years of age * Refractory to anti-seizure medications (ASMs). * Persistence of disabling seizures at least 3 times per 3 months or greater, and once or more in recent 1 month. * After comprehensive preoperative evaluation, patients who are considered unsuitable for or refuse resection surgery, or those for whom the effects of epileptic focus resection and thermocoagulation surgery are not satisfactory. * Participants must have had a non-invasive video-EEG monitoring revealing seizure semiology and ictal EEG consistent with bilateral Temporal Lobe Epilepsy * Biliteral hippocampal atrophy on MRI T1 imaging with increased ipsilateral mesial signal on T2 imaging * Informed consent signed.
Exclusion criteria
* Diagnosed with generalized or hereditary epilepsy with ion channel gene mutations; * Psychogenic non-epileptic seizures within 12 months; * Presence of implanted electrical stimulation medical device anywhere in the body (e.g., pacemaker, spinal cord stimulator, responsive neurostimulation) or any metallic implants in the head (e.g., aneurysm clips, cochlear implants). Note: Vagal nerve stimulators are allowed if the parameter remains stable for at least 3 months prior to the screening visit; * Risk factors that would put the participant at risk for intraoperative or postoperative bleeding. (e.g., coagulation abnormalities, etc.) or the need for chronic anticoagulation or antiplatelet aggregation medications; * IQ \< 55 or severe cognitive dysfunction, unable to complete the study; * Diagnosed with a progressive neurological disorder (including progressive Rasmussen's encephalitis, etc.); * Diagnosed with a severe neuropsychiatric disorder such as dementia, major depression (admission to a psychiatric specialty/hospital within 5 years or any suicidal or self-injurious tendencies), schizophrenia, or neurodegenerative disorders; * Diagnosed with other serious physical disorders, internal diseases or severe abnormalities in liver or kidney function; * Pregnant, or planning to pregnant within 2 years; * Participation in another clinical study within 3 months; * Not suitable for enrollment as assessed by the multidisciplinary team of the center.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Seizure frequency (SF28) | Up to 1 year after piriform cortex-DBS | Seizure frequency (SF28) is defined as seizure count per month (28-day) period. The SF28 is calculated as follows, where D=total number of days for which seizure information is collected for the specific 28-day interval: SF28=(Total number of seizures in D days/D)\*28. In addition, the baseline seizure frequency is defined as mean of 3-month SF28 in the baseline period. The seizure frequency in open-label phase is defined as SF28 per month during the open-label period. Percent change in seizure frequency=100\*(open-label SF28-baseline SF28)/baseline SF28. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Life quality evaluation | Up to 1 year after piriform cortex-DBS | Percentage change from baseline in Quality of Life in Epilepsy-31 inventory (QOLIE-31) score. |
| Cognitive function evaluation (MMSE) | Up to 1 year after piriform cortex-DBS | Percentage change from baseline in Mini-Mental State Examination (MMSE) score. |
| Seizure Responder Rate | Up to 1 year after piriform cortex-DBS | The proportion of patients with a ≥ 50% reduction from Baseline in seizure frequency. |
| Adverse Events | Up to 1 year after piriform cortex-DBS | Rate of adverse events which were judged to be study-related throughout the study. |
| Incidence of Sudden Unexpected Death in Epilepsy (SUDEP) | Up to 1 year after piriform cortex-DBS | The number presented is for Definite and Probable SUDEP. The rate is calculated per 1000 subject years of follow-up. |
| Cognitive function evaluation (MoCA) | Up to 1 year after piriform cortex-DBS | Percentage change from baseline in Montreal Cognitive Assessment (MoCA) score. |
Contacts
Primary ContactLiankun Ren, MD
Outcome results
None listed