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

December 8, 2016 updated by: Beijing Pins Medical Co., Ltd
Evaluate the long-term clinical effectiveness and safety of the PINS Deep Brain Stimulation to patients with refractory epilepsy.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Luming Li
  • Phone Number: +86 010-60736388

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100050
        • Recruiting
        • Beijing Tiantan Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 60 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Changes in seizure frequency from baseline to the seizure count evaluation period 6 month
Time Frame: 6 month of stimulation
6 month of stimulation

Secondary Outcome Measures

Outcome Measure
Time Frame
Changes in seizure frequency from baseline to the seizure count evaluation period
Time Frame: 1,3,6,12 months of stimulation
1,3,6,12 months of stimulation
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
Mean change from baseline QOLIE-31 Overall Score at 1,3,6,12 months
Change in the Number of Anti-epileptic Drugs Prescribed
Time Frame: At 1,3,6,12 months
At 1,3,6,12 months
Change from Baseline in the Engel and McHugh description
Time Frame: At 1,3,6,12 months
At 1,3,6,12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beijing Pins Medical Co., Ltd

Collaborators

Beijing Tiantan Hospital

Investigators

  • Study Chair: Luming Li, Study Principal Investigator

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2015

Primary Completion (Anticipated)

October 1, 2017

Study Completion (Anticipated)

December 1, 2017

Study Registration Dates

First Submitted

October 10, 2015

First Submitted That Met QC Criteria

November 10, 2015

First Posted (Estimate)

November 11, 2015

Study Record Updates

Last Update Posted (Estimate)

December 12, 2016

Last Update Submitted That Met QC Criteria

December 8, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PINS-013

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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