Prospective Cohort Study on the Efficacy of Vagus Nerve Stimulation for Children and Adolescents With Epilepsy(PVNS-CAE)

Epileptic Encephalopathy Clinical Trial

Official title:

Prospective Cohort Study on the Efficacy of Vagus Nerve Stimulation for Children and Adolescents With Epilepsy(PVNS-CAE)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02603991
• Other study ID #: PINS-015
• Status: Recruiting
• Phase: N/A
• First received: November 9, 2015
• Last updated: October 12, 2016
• Start date: June 2016
• Est. completion date: October 2017

Study information

• Verified date: October 2016
• Source: Beijing Pins Medical Co., Ltd
• Contact: Fumin Jia, PhD
• Phone: +86-010-59361265
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Observational

Clinical Trial Summary

Prospective cohort study on the long-term effectiveness and safety of PINS vagus nerve stimulators for children and adolescent with refractory epilepsy.

Description:

Epileptic encephalopathy is very common in children and adolescent with epilepsy, but there is no data in clinical studies.The aim of this study is to evaluate the efficacy of the long-term vagus nerve stimulation for children and adolescent with epilepsy

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1
• Est. completion date: October 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 4 Years to 18 Years

Eligibility

Inclusion Criteria:

1. age 4-18

2. Diagnostic criteria for epilepsia brain disorders

3. Having tried appropriate anti-epileptic drugs (AEDs) more than 1 year and zt least 6 seizures per month

4. patients or his(her) families could understand this method and sign the informed consent

5. Patients with good compliance and could complete postoperative follow-up

Exclusion Criteria:

1. the vagus nerve lesion and damage

2. patients with progressive neurological diseases, cardiopulmonary anomaly, respiratory system diseases,digestive system diseases

3. patients'mental state is not stable,

4. patients with or anesthesia contraindications,such as long-term use of anticoagulation antiplatelet drugs etc.

5. patients have or need other implantable devices, such as pacemakers,defibrillators, cochlear and spinal nerve root stimulator.

6. patients due to their own reasons for the need for nuclear magnetic resonance imaging in the future clinical trials

7. patients have participated in other clinical trials.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Brain Diseases
• Epilepsy
• Epileptic Encephalopathy

Intervention

Procedure:
• PINS Vagus Nerve Stimulator
The stimulators are implanted in the body,with the stimulation of the IPG

Drug:
• Levetiracetam
The best anti-epileptic drugs to patients who participate in this study,Levetiracetam,

Locations

Country	Name	City	State
China	Beijing Tiantan Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Pins Medical Co., Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The change of the score in Quality of Life in Children with Epilepsy		QOLCE Scores at 3,6,9,12,18, 24 month of stimulation	No
Secondary	Respondent rate		Respondent rate at 3,6,9,12,24 month	No
Secondary	seizure free rate		seizure free rate at 3,6,9,12, 24 month	No
Secondary	complication		complication at 3,6,9,12, 24 month	No