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

Study Overview
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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.

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

Conditions
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Refractory Epilepsy

Intervention / Treatment
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* Procedure: PINS'Deep Brain Stimulator device


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PINS Deep Brain Stimulator<br>Deep Brain Stimulator is on,continuous stimulation to the brain, | Procedure: PINS'Deep Brain Stimulator device<br>* deep brain stimulation of the PINS'IPG function to anterior nucleus of the thalamus is off in a short time<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PINS, Deep Brain Stimulator, Refractory Epilepsy, Anterior Thalamic Nucleus