Epilepsy, Temporal Lobe
Conditions
Brief summary
The study aims to compare the safety and effectiveness of deep brain stimulation of the hippocampus and the anterior nucleus of the thalamus for reducing the frequency of seizures in patients with bilateral temporal lobe epilepsy.
Detailed description
The outcome of resective surgery for bilateral temporal lobe epilepsy (BTLE) is poor. Neuromodulation such as deep brain stimulation is an alternative therapy for patients with drug-resistant epilepsy, especially for those not suitable for resective surgery. This prospective, randomized, open-label trial aims to compare the effectiveness of deep brain stimulation of the hippocampus and the anterior nucleus of the thalamus for bilateral temporal lobe epilepsy.
Interventions
DEVICEdeep brain stimulation
deep brain stimulation on the hippocampus or the anterior nucleus of the thalamus
Sponsors
Beijing Tiantan Hospital
The Second Hospital of Hebei Medical University
Zhejiang Provincial People's Hospital
Second Affiliated Hospital, School of Medicine, Zhejiang University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
1. Patients between 12 to 60 years old. 2. Bilateral temporal lobe epilepsy patients proved by VEEG or SEEG. 3. At least 3 seizures per month but not more than 10 seizures per month, and the longest seizure interval is no more than 30 days during the baseline. 4. Patients failed to at least 3 antiepileptic drugs (AEDs), and are receiving at least 1 AEDs now. 5. Be able to complete seizure diary. 6. Agree to participate this study and sign informed consent.
Exclusion criteria
1. Extratemporal lobe epilepsy or with potential extratemporal epileptogenic focus. 2. Patients with psychogenic non-epileptic seizures. 3. IQ \< 70, or unable to complete the study. 4. Patients are pregnant or plan for it. 5. Patients with implanted electrical stimulation medical device. 6. Patients with other severe neuropsychiatric disorders such as dementia, schizophrenia, or neurodegenerative diseases. 7. Patients with cerebral lesions which unsuitable for lead implantation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Seizure Frequency | 3 years after DBS | The seizure frequency after DBS compared to the seizure frequency in baseline. |
| Responder Rate | 3 years after DBS | The rate of patients response to DBS, patients have at least 50% decrease in average seizure frequency after DBS are considered as responder. |
| Seizure-Free Rate | 3 years after DBS | The rate of patients who achieve seizure free after DBS. Patients don't have seizure for at least 1 year are considered seizure free. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in the Maximum Length of Seizure Intervals | 1 year and 3 years after DBS | The maximum length of seizure intervals after DBS compared to the maximum length of seizure intervals in baseline. |
| Change in GTCS Frequency | 1 year and 3 years after DBS | The GTCS frequency after DBS compared to the GTCS frequency in baseline. |
| Change in Memory | 1 year and 3 years after DBS | The memory test scores after DBS compared to baseline. Wechsler memory scale (WMS, ≤51 \ 150, higher scores mean better outcome) |
| Change in Cognitive Function | 1 year and 3 years after DBS | The cognitive test scores after DBS compared to baseline. Montreal Cognitive Assessment(MoCA, 0-30 scores, higher scores mean better outcome) |
| Incidence Rate of Sudden Unexplained Death in Epilepsy (SUDEP) | 1 year and 3 years after DBS | The Incidence Rate after DBS. |
| Change in Depression | 1 year and 3 years after DBS | The depression test scores after DBS compared to baseline. Hamilton depression scale (HAMD, 0-64 scores, lower scores mean better outcome) |
| Change in Percentage of Seizure-free Days | 1 year and 3 years after DBS | The percentage of seizure-free days after DBS compared to the percentage of seizure-free days in baseline. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Adverse Events Rate | 1 year and 3 years after DBS | The rate of adverse events related to the implantation surgery or DBS devices. |
Countries
China
Contacts
Primary ContactShuang Wang, MD
Outcome results
None listed