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

Refractory Epilepsy Clinical Trial

— ANT-DBS-RE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02602899
• Other study ID #: PINS-013
• Status: Recruiting
• Phase: N/A
• First received: October 10, 2015
• Last updated: December 8, 2016
• Start date: April 2015
• Est. completion date: December 2017

Study information

• Verified date: October 2016
• Source: Beijing Pins Medical Co., Ltd
• Contact: Fumin Jia
• Phone: +86 010-59361265
• Email: pins_medical[@]163.con
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 2017
• Est. primary completion date: October 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years to 60 Years

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Drug Resistant Epilepsy
• Epilepsy
• Refractory Epilepsy

Intervention

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

Locations

Country	Name	City	State
China	Beijing Tiantan Hospital	Beijing	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
Beijing Pins Medical Co., Ltd	Beijing Tiantan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in seizure frequency from baseline to the seizure count evaluation period 6 month		6 month of stimulation	No
Secondary	Changes in seizure frequency from baseline to the seizure count evaluation period		1,3,6,12 months of stimulation	No
Secondary	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	No
Secondary	Change in the Number of Anti-epileptic Drugs Prescribed		At 1,3,6,12 months	No
Secondary	Change from Baseline in the Engel and McHugh description		At 1,3,6,12 months	No