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| Name | Class |
|---|---|
| Beijing Tiantan Hospital | OTHER |
| The Second Hospital of Hebei Medical University | OTHER |
| Zhejiang Provincial People's Hospital | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| stimulation on the hippocampus | Experimental | deep brain stimulation on the hippocampus |
|
| stimulation on the anterior nucleus of the thalamus | Active Comparator | deep brain stimulation on the anterior nucleus of the thalamus |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| deep brain stimulation | Device | deep brain stimulation on the hippocampus or the anterior nucleus of the thalamus |
|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events Rate | The rate of adverse events related to the implantation surgery or DBS devices. | 1 year and 3 years after DBS |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shuang Wang, MD | Contact | +86 0571-87767120 | wangs77@zju.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Shuang Wang, MD | Epilepsy Center, Second Affiliated Hospital, School of Medicine, Zhejiang University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 2nd Affiliated Hospital, School of Medicine, Zhejiang University | Recruiting | Hangzhou | Zhejiang | 310000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20331461 | Result | 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. | |
| 25663221 |
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| ID | Term |
|---|---|
| D004833 | Epilepsy, Temporal Lobe |
| ID | Term |
|---|---|
| D004828 | Epilepsies, Partial |
| D004827 | Epilepsy |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D046690 | Deep Brain Stimulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D013514 | Surgical Procedures, Operative |
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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 |
| Result |
| 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, 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. |
| D009422 |
| Nervous System Diseases |
| D000073376 | Epileptic Syndromes |