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Deep Brain Stimulation of the Anterior Nucleus of the Thalamus in Refractory Epilepsy (ANT-DBS-RE)

Primary Purpose

Refractory Epilepsy

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
PINS'Deep Brain Stimulator device
Sponsored by
Beijing Pins Medical Co., Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Refractory Epilepsy focused on measuring PINS, Deep Brain Stimulator, Refractory Epilepsy, Anterior Thalamic Nucleus

Eligibility Criteria

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

Inclusion Criteria:

  • age 12-60.
  • having tried at least two appropriate anti-epileptic drugs (AEDs) tested to tolerance or to blood levels at upper end of the target range of which at least 2 have been tolerated at normal dose.
  • at least 6 seizures per month.
  • in good health except epilepsy.
  • to with normal MMSE score
  • patients or his(her) familys could understand this method and sign the informed consent 7）Patients with good compliance and could complete postoperative follow-up

Exclusion Criteria:

  • results of MRI remind epilepsy caused by intracranial space-occupying lesions.
  • the vagus nerve lesion and damage
  • tumor, cardiopulmonary anomaly, progressive neurological diseases, asthma，mental disease，peptic ulcer，diabetes Type 1，bad health etc, and other surgical contraindication.

Sites / Locations

  • Beijing Tiantan HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

PINS Deep Brain Stimulator

Arm Description

Deep Brain Stimulator is on,continuous stimulation to the brain,

Outcomes

Primary Outcome Measures

Changes in seizure frequency from baseline to the seizure count evaluation period 6 month

Secondary Outcome Measures

Changes in seizure frequency from baseline to the seizure count evaluation period
Overall Quality of Life in Epilepsy-31 (QOLIE-31) Score in Patients With Baseline & at Least One Post-baseline QOLIE Assessment
Change in the Number of Anti-epileptic Drugs Prescribed
Change from Baseline in the Engel and McHugh description

Full Information

First Posted
October 10, 2015
Last Updated
December 8, 2016
Sponsor
Beijing Pins Medical Co., Ltd
Collaborators
Beijing Tiantan Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02602899
Brief Title
Deep Brain Stimulation of the Anterior Nucleus of the Thalamus in Refractory Epilepsy
Acronym
ANT-DBS-RE
Official Title
Deep Brain Stimulation of the Anterior Nucleus of the Thalamus in Refractory Epilepsy
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Unknown status
Study Start Date
April 2015 (undefined)
Primary Completion Date
October 2017 (Anticipated)
Study Completion Date
December 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Beijing Pins Medical Co., Ltd
Collaborators
Beijing Tiantan Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Evaluate the long-term clinical effectiveness and safety of the PINS Deep Brain Stimulation to patients with refractory epilepsy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Refractory Epilepsy
Keywords
PINS, Deep Brain Stimulator, Refractory Epilepsy, Anterior Thalamic Nucleus

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
PINS Deep Brain Stimulator
Arm Type
Experimental
Arm Description
Deep Brain Stimulator is on,continuous stimulation to the brain,
Intervention Type
Procedure
Intervention Name(s)
PINS'Deep Brain Stimulator device
Intervention Description
deep brain stimulation of the PINS'IPG function to anterior nucleus of the thalamus is off in a short time
Primary Outcome Measure Information:
Title
Changes in seizure frequency from baseline to the seizure count evaluation period 6 month
Time Frame
6 month of stimulation
Secondary Outcome Measure Information:
Title
Changes in seizure frequency from baseline to the seizure count evaluation period
Time Frame
1,3,6,12 months of stimulation
Title
Overall Quality of Life in Epilepsy-31 (QOLIE-31) Score in Patients With Baseline & at Least One Post-baseline QOLIE Assessment
Time Frame
Mean change from baseline QOLIE-31 Overall Score at 1,3,6,12 months
Title
Change in the Number of Anti-epileptic Drugs Prescribed
Time Frame
At 1,3,6,12 months
Title
Change from Baseline in the Engel and McHugh description
Time Frame
At 1,3,6,12 months

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: age 12-60. having tried at least two appropriate anti-epileptic drugs (AEDs) tested to tolerance or to blood levels at upper end of the target range of which at least 2 have been tolerated at normal dose. at least 6 seizures per month. in good health except epilepsy. to with normal MMSE score patients or his(her) familys could understand this method and sign the informed consent 7）Patients with good compliance and could complete postoperative follow-up Exclusion Criteria: results of MRI remind epilepsy caused by intracranial space-occupying lesions. the vagus nerve lesion and damage tumor, cardiopulmonary anomaly, progressive neurological diseases, asthma，mental disease，peptic ulcer，diabetes Type 1，bad health etc, and other surgical contraindication.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Fumin Jia
Phone
+86 010-59361265
Email
pins_medical@163.con
First Name & Middle Initial & Last Name or Official Title & Degree
Luming Li
Phone
+86 010-60736388
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Luming Li
Organizational Affiliation
study principal investigator
Official's Role
Study Chair
Facility Information:
Facility Name
Beijing Tiantan Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100050
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jianguo Zhang, MD
Phone
010-67096611
Email
Limuxin2011@163.com

12. IPD Sharing Statement

Learn more about this trial

Deep Brain Stimulation of the Anterior Nucleus of the Thalamus in Refractory Epilepsy

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