Hippocampal and Thalamic DBS for Bilateral Temporal Lobe Epilepsy

Zhejiang University

Status and phase: Enrolling; Phase 4

Conditions: Epilepsy, Temporal Lobe

Treatments: Device: deep brain stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT04164056

2019-192

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 estimated patients

Sex: All

Ages: 12 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

stimulation on the hippocampus

Experimental group

Description:

deep brain stimulation on the hippocampus

Treatment:

Device: deep brain stimulation

stimulation on the anterior nucleus of the thalamus

Active Comparator group

Description:

deep brain stimulation on the anterior nucleus of the thalamus

Treatment:

Device: deep brain stimulation