search
Back to results

Hippocampal and Thalamic DBS for Bilateral Temporal Lobe Epilepsy

Primary Purpose

Epilepsy, Temporal Lobe

Status
Recruiting
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
deep brain stimulation
Sponsored by
Second Affiliated Hospital, School of Medicine, Zhejiang University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Epilepsy, Temporal Lobe

Eligibility Criteria

12 Years - 60 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • 2nd Affiliated Hospital, School of Medicine, Zhejiang UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

stimulation on the hippocampus

stimulation on the anterior nucleus of the thalamus

Arm Description

deep brain stimulation on the hippocampus

deep brain stimulation on the anterior nucleus of the thalamus

Outcomes

Primary Outcome Measures

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.
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.
Change in Seizure Frequency
The seizure frequency after DBS compared to the seizure frequency in baseline.

Secondary Outcome Measures

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.
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.
Change in GTCS Frequency
The GTCS frequency after DBS compared to the GTCS frequency in baseline.
Incidence Rate of Sudden Unexplained Death in Epilepsy (SUDEP)
The Incidence Rate 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)
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)
Change in Depression
The depression test scores after DBS compared to baseline. Hamilton depression scale (HAMD, 0-64 scores, lower scores mean better outcome)

Full Information

First Posted
October 10, 2019
Last Updated
November 13, 2019
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
search

1. Study Identification

Unique Protocol Identification Number
NCT04164056
Brief Title
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

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Recruiting
Study Start Date
November 2019 (Anticipated)
Primary Completion Date
September 2022 (Anticipated)
Study Completion Date
September 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the 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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy, Temporal Lobe

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
stimulation on the hippocampus
Arm Type
Experimental
Arm Description
deep brain stimulation on the hippocampus
Arm Title
stimulation on the anterior nucleus of the thalamus
Arm Type
Active Comparator
Arm Description
deep brain stimulation on the anterior nucleus of the thalamus
Intervention Type
Device
Intervention Name(s)
deep brain stimulation
Intervention Description
deep brain stimulation on the hippocampus or the anterior nucleus of the thalamus
Primary Outcome Measure Information:
Title
Responder Rate
Description
The rate of patients response to DBS, patients have at least 50% decrease in average seizure frequency after DBS are considered as responder.
Time Frame
3 years after DBS
Title
Seizure-Free Rate
Description
The rate of patients who achieve seizure free after DBS. Patients don't have seizure for at least 1 year are considered seizure free.
Time Frame
3 years after DBS
Title
Change in Seizure Frequency
Description
The seizure frequency after DBS compared to the seizure frequency in baseline.
Time Frame
3 years after DBS
Secondary Outcome Measure Information:
Title
Change in Percentage of Seizure-free Days
Description
The percentage of seizure-free days after DBS compared to the percentage of seizure-free days in baseline.
Time Frame
1 year and 3 years after DBS
Title
Change in the Maximum Length of Seizure Intervals
Description
The maximum length of seizure intervals after DBS compared to the maximum length of seizure intervals in baseline.
Time Frame
1 year and 3 years after DBS
Title
Change in GTCS Frequency
Description
The GTCS frequency after DBS compared to the GTCS frequency in baseline.
Time Frame
1 year and 3 years after DBS
Title
Incidence Rate of Sudden Unexplained Death in Epilepsy (SUDEP)
Description
The Incidence Rate after DBS.
Time Frame
1 year and 3 years after DBS
Title
Change in Memory
Description
The memory test scores after DBS compared to baseline. Wechsler memory scale (WMS, ≤51 ~ 150, higher scores mean better outcome)
Time Frame
1 year and 3 years after DBS
Title
Change in Cognitive Function
Description
The cognitive test scores after DBS compared to baseline. Montreal Cognitive Assessment(MoCA, 0-30 scores, higher scores mean better outcome)
Time Frame
1 year and 3 years after DBS
Title
Change in Depression
Description
The depression test scores after DBS compared to baseline. Hamilton depression scale (HAMD, 0-64 scores, lower scores mean better outcome)
Time Frame
1 year and 3 years after DBS
Other Pre-specified Outcome Measures:
Title
Adverse Events Rate
Description
The rate of adverse events related to the implantation surgery or DBS devices.
Time Frame
1 year and 3 years after DBS

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shuang Wang, MD
Phone
+86 0571-87767120
Email
wangs77@zju.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shuang Wang, MD
Organizational Affiliation
Epilepsy Center, Second Affiliated Hospital, School of Medicine, Zhejiang University
Official's Role
Principal Investigator
Facility Information:
Facility Name
2nd Affiliated Hospital, School of Medicine, Zhejiang University
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shuang Wang, MD
Phone
+86 0571-87767120
Email
wangs77@zju.edu.cn

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
20331461
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.
Results Reference
result
PubMed Identifier
25663221
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.
Results Reference
result

Learn more about this trial

Hippocampal and Thalamic DBS for Bilateral Temporal Lobe Epilepsy

We'll reach out to this number within 24 hrs