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

NCT ID: NCT02602899

Last Updated: 2016-12-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-04-30

Study Completion Date

2017-12-31

Brief Summary

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

Detailed Description

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Conditions

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Refractory Epilepsy

Keywords

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PINS Deep Brain Stimulator Refractory Epilepsy Anterior Thalamic Nucleus

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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PINS Deep Brain Stimulator

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

Group Type EXPERIMENTAL

PINS'Deep Brain Stimulator device

Intervention Type PROCEDURE

deep brain stimulation of the PINS'IPG function to anterior nucleus of the thalamus is off in a short time

Interventions

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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

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

12 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Beijing Tiantan Hospital

OTHER

Sponsor Role collaborator

Beijing Pins Medical Co., Ltd

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Luming Li

Role: STUDY_CHAIR

study principal investigator

Locations

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Beijing Tiantan Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Fumin Jia

Role: CONTACT

Phone: +86 010-59361265

Email: [email protected]

Luming Li

Role: CONTACT

Phone: +86 010-60736388

Facility Contacts

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Jianguo Zhang, MD

Role: primary

Other Identifiers

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PINS-013

Identifier Type: -

Identifier Source: org_study_id