Hippocampal and Thalamic DBS for Bilateral Temporal Lobe Epilepsy

Study Overview
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Brief Summary
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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
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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.

Official Title
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Hippocampal and Thalamic Deep Brain Stimulation for Bilateral Temporal Lobe Epilepsy

Conditions
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Epilepsy, Temporal Lobe

Intervention / Treatment
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* Device: deep brain stimulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients between 12 to 60 years old. Bilateral temporal lobe epilepsy patients proved by VEEG or SEEG. 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. Patients failed to at least 3 antiepileptic drugs (AEDs), and are receiving at least 1 AEDs now. Be able to complete seizure diary. Agree to participate this study and sign informed consent. Exclusion Criteria: Extratemporal lobe epilepsy or with potential extratemporal epileptogenic focus. Patients with psychogenic non-epileptic seizures. IQ < 70, or unable to complete the study. Patients are pregnant or plan for it. Patients with implanted electrical stimulation medical device. Patients with other severe neuropsychiatric disorders such as dementia, schizophrenia, or neurodegenerative diseases. Patients with cerebral lesions which unsuitable for lead implantation.

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: stimulation on the hippocampus<br>deep brain stimulation on the hippocampus | Device: deep brain stimulation<br>* deep brain stimulation on the hippocampus or the anterior nucleus of the thalamus<br>|
| Active Comparator: stimulation on the anterior nucleus of the thalamus<br>deep brain stimulation on the anterior nucleus of the thalamus | Device: deep brain stimulation<br>* deep brain stimulation on the hippocampus or the anterior nucleus of the thalamus<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Responder Rate | The rate of patients response to DBS, patients have at least 50% decrease in average seizure frequency after DBS are considered as responder. | 3 years after DBS | 
| Seizure-Free Rate | The rate of patients who achieve seizure free after DBS. Patients don't have seizure for at least 1 year are considered seizure free. | 3 years after DBS | 
| Change in Seizure Frequency | The seizure frequency after DBS compared to the seizure frequency in baseline. | 3 years after DBS | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Percentage of Seizure-free Days | The percentage of seizure-free days after DBS compared to the percentage of seizure-free days in baseline. | 1 year and 3 years after DBS | 
| Change in the Maximum Length of Seizure Intervals | The maximum length of seizure intervals after DBS compared to the maximum length of seizure intervals in baseline. | 1 year and 3 years after DBS | 
| Change in GTCS Frequency | The GTCS frequency after DBS compared to the GTCS frequency in baseline. | 1 year and 3 years after DBS | 
| Incidence Rate of Sudden Unexplained Death in Epilepsy (SUDEP) | The Incidence Rate after DBS. | 1 year and 3 years after DBS | 
| Change in Memory | The memory test scores after DBS compared to baseline. Wechsler memory scale (WMS, ≤51   150, higher scores mean better outcome) | 1 year and 3 years after DBS | 
| Change in Cognitive Function | The cognitive test scores after DBS compared to baseline. Montreal Cognitive Assessment(MoCA, 0-30 scores, higher scores mean better outcome) | 1 year and 3 years after DBS | 
| Change in Depression | The depression test scores after DBS compared to baseline. Hamilton depression scale (HAMD, 0-64 scores, lower scores mean better outcome) | 1 year and 3 years after DBS |