Hippocampal and Thalamic DBS for Bilateral Temporal Lobe Epilepsy

Phase 4

Recruiting

• Conditions: Epilepsy, Temporal Lobe
• Interventions: Device: deep brain stimulation

• Registration Number: NCT04164056
• Lead Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

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.

Study Timeline

• Status Verified: 2019-10
• Study First Submitted: 2019-10-10
• Study Start: 2019-11
• Study First Submitted QC: 2019-11-13
• Last Update Submitted: 2019-11-13
• Study First Posted: 2019-11-15
• Last Update Posted: 2019-11-15
• Primary Completion: 2022-09
• Study Completion: 2024-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
stimulation on the hippocampus	deep brain stimulation	deep brain stimulation on the hippocampus
stimulation on the anterior nucleus of the thalamus	deep brain stimulation	deep brain stimulation on the anterior nucleus of the thalamus

Primary Outcome Measures

Name	Time	Method
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.
Change in Seizure Frequency	3 years after DBS	The seizure frequency after DBS compared to the seizure frequency in baseline.

Secondary Outcome Measures

Name	Time	Method
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.
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.
Incidence Rate of Sudden Unexplained Death in Epilepsy (SUDEP)	1 year and 3 years after DBS	The Incidence Rate after DBS.
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)
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)

Trial Locations

Locations (1)

2nd Affiliated Hospital, School of Medicine, Zhejiang University; 🇨🇳 Hangzhou, Zhejiang, China