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

Not Applicable

• Conditions: Refractory Epilepsy

• Registration Number: NCT02602899
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-04
• Study First Submitted: 2015-10-10
• Study First Submitted QC: 2015-11-10
• Study First Posted: 2015-11-11
• Status Verified: 2016-10
• Last Update Submitted: 2016-12-08
• Last Update Posted: 2016-12-12
• Primary Completion: 2017-10
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Changes in seizure frequency from baseline to the seizure count evaluation period 6 month	6 month of stimulation

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Beijing Tiantan Hospital; 🇨🇳 Beijing, Beijing, China