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

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ClinicalTrials.gov Identifier: NCT02602899
Recruitment Status : Unknown
Verified October 2016 by Beijing Pins Medical Co., Ltd.
Recruitment status was:  Recruiting
First Posted : November 11, 2015
Last Update Posted : December 12, 2016
Sponsor:
Collaborator:
Beijing Tiantan Hospital
Information provided by (Responsible Party):
Beijing Pins Medical Co., Ltd

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

Condition or disease Intervention/treatment Phase
Refractory Epilepsy Procedure: PINS'Deep Brain Stimulator device Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Deep Brain Stimulation of the Anterior Nucleus of the Thalamus in Refractory Epilepsy
Study Start Date : April 2015
Estimated Primary Completion Date : October 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Epilepsy

Arm Intervention/treatment
Experimental: PINS Deep Brain Stimulator
Deep Brain Stimulator is on,continuous stimulation to the brain,
Procedure: PINS'Deep Brain Stimulator device
deep brain stimulation of the PINS'IPG function to anterior nucleus of the thalamus is off in a short time




Primary Outcome Measures :
  1. Changes in seizure frequency from baseline to the seizure count evaluation period 6 month [ Time Frame: 6 month of stimulation ]

Secondary Outcome Measures :
  1. Changes in seizure frequency from baseline to the seizure count evaluation period [ Time Frame: 1,3,6,12 months of stimulation ]
  2. 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 ]
  3. Change in the Number of Anti-epileptic Drugs Prescribed [ Time Frame: At 1,3,6,12 months ]
  4. Change from Baseline in the Engel and McHugh description [ Time Frame: At 1,3,6,12 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02602899


Contacts
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Contact: Fumin Jia +86 010-59361265 pins_medical@163.con
Contact: Luming Li +86 010-60736388

Locations
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China, Beijing
Beijing Tiantan Hospital Recruiting
Beijing, Beijing, China, 100050
Contact: Jianguo Zhang, MD    010-67096611    Limuxin2011@163.com   
Sponsors and Collaborators
Beijing Pins Medical Co., Ltd
Beijing Tiantan Hospital
Investigators
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Study Chair: Luming Li study principal investigator

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Responsible Party: Beijing Pins Medical Co., Ltd
ClinicalTrials.gov Identifier: NCT02602899     History of Changes
Other Study ID Numbers: PINS-013
First Posted: November 11, 2015    Key Record Dates
Last Update Posted: December 12, 2016
Last Verified: October 2016

Keywords provided by Beijing Pins Medical Co., Ltd:
PINS
Deep Brain Stimulator
Refractory Epilepsy
Anterior Thalamic Nucleus

Additional relevant MeSH terms:
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Epilepsy
Drug Resistant Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases