Clinical trial NCT04164056: Hippocampal and Thalamic DBS for Bilateral Temporal Lobe Epilepsy
Official title: Hippocampal and Thalamic Deep Brain Stimulation for Bilateral Temporal Lobe Epilepsy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Epilepsy, Temporal Lobe
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
Collaborators: name: Beijing Tiantan Hospital
name: The Second Hospital of Hebei Medical University
name: Zhejiang Provincial People's Hospital
First posted: 2019-11-15
Enrollment: 80
Sex: ALL
Minimum age (years): 12
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Responder Rate
timeFrame: 3 years after DBS
measure: Seizure-Free Rate
timeFrame: 3 years after DBS
measure: Change in Seizure Frequency
timeFrame: 3 years after DBS
Secondary outcomes:
measure: Change in Percentage of Seizure-free Days
timeFrame: 1 year and 3 years after DBS
measure: Change in the Maximum Length of Seizure Intervals
timeFrame: 1 year and 3 years after DBS
measure: Change in GTCS Frequency
timeFrame: 1 year and 3 years after DBS
measure: Incidence Rate of Sudden Unexplained Death in Epilepsy (SUDEP)
timeFrame: 1 year and 3 years after DBS
measure: Change in Memory
timeFrame: 1 year and 3 years after DBS
measure: Change in Cognitive Function
timeFrame: 1 year and 3 years after DBS
measure: Change in Depression
timeFrame: 1 year and 3 years after DBS
Other outcomes:
measure: Adverse Events Rate
timeFrame: 1 year and 3 years after DBS
Locations:
city: Hangzhou
country: China
facility: 2nd Affiliated Hospital, School of Medicine, Zhejiang University
state: Zhejiang
Study officials:
affiliation: Epilepsy Center, Second Affiliated Hospital, School of Medicine, Zhejiang University
name: Shuang Wang, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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, 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.