Hippocampal and Thalamic DBS for Bilateral Temporal Lobe Epilepsy

Epilepsy, Temporal Lobe Clinical Trial

Official title:

Hippocampal and Thalamic Deep Brain Stimulation for Bilateral Temporal Lobe Epilepsy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04164056
• Other study ID #: 2019-192
• Status: Recruiting
• Phase: Phase 4
• Start date: November 2019
• Est. completion date: September 2024

Study information

• Verified date: October 2019
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: Shuang Wang, MD
• Phone: +86 0571-87767120
• Email: wangs77[@]zju.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: September 2024
• Est. primary completion date: September 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Epilepsy
• Epilepsy, Temporal Lobe

Intervention

Device:
• deep brain stimulation
deep brain stimulation on the hippocampus or the anterior nucleus of the thalamus

Locations

Country	Name	City	State
China	2nd Affiliated Hospital, School of Medicine, Zhejiang University	Hangzhou	Zhejiang

Sponsors (4)

Lead Sponsor	Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University	Beijing Tiantan Hospital, The Second Hospital of Hebei Medical University, Zhejiang Provincial People’s Hospital

Country where clinical trial is conducted

China, 

References & Publications (2)

Fisher R, Salanova V, Witt T, Worth R, Henry T, Gross R, Oommen K, Osorio I, Nazzaro J, Labar D, Kaplitt M, Sperling M, Sandok E, Neal J, Handforth A, Stern J, DeSalles A, Chung S, Shetter A, Bergen D, Bakay R, Henderson J, French J, Baltuch G, Rosenfeld — View Citation

Salanova V, Witt T, Worth R, Henry TR, Gross RE, Nazzaro JM, Labar D, Sperling MR, Sharan A, Sandok E, Handforth A, Stern JM, Chung S, Henderson JM, French J, Baltuch G, Rosenfeld WE, Garcia P, Barbaro NM, Fountain NB, Elias WJ, Goodman RR, Pollard JR, Tr — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Adverse Events Rate	The rate of adverse events related to the implantation surgery or DBS devices.	1 year and 3 years after DBS
Primary	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
Primary	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
Primary	Change in Seizure Frequency	The seizure frequency after DBS compared to the seizure frequency in baseline.	3 years after DBS
Secondary	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
Secondary	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
Secondary	Change in GTCS Frequency	The GTCS frequency after DBS compared to the GTCS frequency in baseline.	1 year and 3 years after DBS
Secondary	Incidence Rate of Sudden Unexplained Death in Epilepsy (SUDEP)	The Incidence Rate after DBS.	1 year and 3 years after DBS
Secondary	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
Secondary	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
Secondary	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