Hippocampal and Thalamic DBS for Bilateral Temporal Lobe Epilepsy
Hippocampal and Thalamic Deep Brain Stimulation for Bilateral Temporal Lobe Epilepsy
1 other identifier
interventional
80
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Nov 2019
Longer than P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 10, 2019
CompletedStudy Start
First participant enrolled
November 1, 2019
CompletedFirst Posted
Study publicly available on registry
November 15, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2024
CompletedNovember 15, 2019
October 1, 2019
2.8 years
October 10, 2019
November 13, 2019
Conditions
Outcome Measures
Primary Outcomes (3)
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 Outcomes (7)
Change in Percentage of Seizure-free Days
1 year and 3 years after DBS
Change in the Maximum Length of Seizure Intervals
1 year and 3 years after DBS
Change in GTCS Frequency
1 year and 3 years after DBS
Incidence Rate of Sudden Unexplained Death in Epilepsy (SUDEP)
1 year and 3 years after DBS
Change in Memory
1 year and 3 years after DBS
- +2 more secondary outcomes
Other Outcomes (1)
Adverse Events Rate
1 year and 3 years after DBS
Study Arms (2)
stimulation on the hippocampus
EXPERIMENTALdeep brain stimulation on the hippocampus
stimulation on the anterior nucleus of the thalamus
ACTIVE COMPARATORdeep brain stimulation on the anterior nucleus of the thalamus
Interventions
deep brain stimulation on the hippocampus or the anterior nucleus of the thalamus
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
2nd Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, 310000, China
Related 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 W, Youkilis A, Marks W, Garcia P, Barbaro N, Fountain N, Bazil C, Goodman R, McKhann G, Babu Krishnamurthy K, Papavassiliou S, Epstein C, Pollard J, Tonder L, Grebin J, Coffey R, Graves N; SANTE Study Group. Electrical stimulation of the anterior nucleus of thalamus for treatment of refractory epilepsy. Epilepsia. 2010 May;51(5):899-908. doi: 10.1111/j.1528-1167.2010.02536.x. Epub 2010 Mar 17.
PMID: 20331461RESULTSalanova 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, Troster AI, Irwin CP, Lambrecht K, Graves N, Fisher R; SANTE Study Group. Long-term efficacy and safety of thalamic stimulation for drug-resistant partial epilepsy. Neurology. 2015 Mar 10;84(10):1017-25. doi: 10.1212/WNL.0000000000001334. Epub 2015 Feb 6.
PMID: 25663221RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Shuang Wang, MD
Epilepsy Center, Second Affiliated Hospital, School of Medicine, Zhejiang University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 10, 2019
First Posted
November 15, 2019
Study Start
November 1, 2019
Primary Completion
September 1, 2022
Study Completion
September 1, 2024
Last Updated
November 15, 2019
Record last verified: 2019-10
Data Sharing
- IPD Sharing
- Will not share