Hippocampal and Thalamic DBS for Bilateral Temporal Lobe Epilepsy

Hippocampal and Thalamic Deep Brain Stimulation for Bilateral Temporal Lobe Epilepsy

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.

Study Overview

• Status: Recruiting
• Conditions: Epilepsy, Temporal Lobe
• Intervention / Treatment: Device: deep brain stimulation

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 Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Shuang Wang, MD; Phone Number: +86 0571-87767120; Email: wangs77@zju.edu.cn

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310000
      • Recruiting
      • 2nd Affiliated Hospital, School of Medicine, Zhejiang University
      • Contact: Shuang Wang, MD; Phone Number: +86 0571-87767120; Email: wangs77@zju.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 60 years (ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: stimulation on the hippocampus; deep brain stimulation on the hippocampus	Device: deep brain stimulation; deep brain stimulation on the hippocampus or the anterior nucleus of the thalamus
ACTIVE_COMPARATOR: stimulation on the anterior nucleus of the thalamus; deep brain stimulation on the anterior nucleus of the thalamus	Device: deep brain stimulation; deep brain stimulation on the hippocampus or the anterior nucleus of the thalamus

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Other Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Collaborators: Beijing Tiantan Hospital; The Second Hospital of Hebei Medical University; Zhejiang Provincial People's Hospital
• Investigators: Principal Investigator: Shuang Wang, MD, Epilepsy Center, Second Affiliated Hospital, School of Medicine, Zhejiang University

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): November 1, 2019
• Primary Completion (ANTICIPATED): September 1, 2022
• Study Completion (ANTICIPATED): September 1, 2024

Study Registration Dates

• First Submitted: October 10, 2019
• First Submitted That Met QC Criteria: November 13, 2019
• First Posted (ACTUAL): November 15, 2019

Study Record Updates

• Last Update Posted (ACTUAL): November 15, 2019
• Last Update Submitted That Met QC Criteria: November 13, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Epileptic Syndromes; Epilepsies, Partial; Epilepsy; Epilepsy, Temporal Lobe
• Other Study ID Numbers: 2019-192

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No