Clinical trial NCT02378792: Clinical Trial of Vagus Nerve Stimulation for Treatment of Refractory Epilepsy
Official title: The Clinical Research on TsingHua Vagus Nerve Stimualtor for Treatment of Refractory Epilepsy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Refractory Epilepsy
Keywords: PINS VNS Refractory Epilepsy
Lead sponsor: Beijing Pins Medical Co., Ltd
Sponsor class: INDUSTRY
Collaborators: name: Beijing Tiantan Hospital
First posted: 2015-03-04
Enrollment: 300
Sex: ALL
Minimum age (years): 6
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Evaluate the long-term clinical effectiveness and safety of the PINS vagus nerve stimulator to patients with refractory epilepsy.


Eligibility criteria: Inclusion Criteria:

1. Age 6-60.
2. 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.
3. At least 1 seizure per month.
4. In good health except epilepsy.
5. With normal MMSE score
6. Patients or his(her) familyscould understand this method and sign the informed consent 7）Patients with good compliance and could complete postoperative follow-up.

Exclusion Criteria:

1. Results of MRI remind epilepsy caused by intracranial space-occupying lesions.
2. The vagus nerve lesion and damage
3. Tumor, cardiopulmonary anomaly, progressive neurological diseases, asthma，mental disease，pepticulcer，diabetes Type 1，bad health etc, and other surgical contraindication
4. Alcohol addiction, smoking, and sleep-related breathing disorders

Primary outcomes:
measure: Changes in seizure frequency from baseline to the seizure count evaluvation period 6 month
timeFrame: 4,8,12,16,20,24 months of stimulation
Secondary outcomes:
measure: Changes in seizure frequency from baseline to the seizure count evaluvation period
timeFrame: 4,8,12,16,20,24 months of stimulation
measure: Overall Quality of Life in Epilepsy-31 (QOLIE-31) Score in Patients With Baseline & at Least One Post-baseline QOLIE Assessment
timeFrame: Mean change from baseline QOLIE-31 Overall Score at 12,24 months
measure: Changes in the Number of Anti-epileptic Drugs Prescribed
timeFrame: At12,24 months
measure: Changes from Basline in the Engel and McHugh description
timeFrame: At 12,24 months
measure: Changes from Basline in 24 hour ECG description
timeFrame: At 12,24 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Tiantan Hospital
state: Beijing
city: Changchun
country: China
facility: The first hospital of jilin university
state: Jilin
city: Shenyang
country: China
facility: The general of shenyang military
state: Liaoning
city: Jinan
country: China
facility: Qilu hospital of shandong university
state: Shandong
city: Hangzhou
country: China
facility: The second affiliated hospital zhejiang university school of medicine
state: Zhejiang
Study officials:
References:
citation: Liu H, Zhan P, Meng F, Wang W. Chronic vagus nerve stimulation for drug-resistant epilepsy may influence fasting blood glucose concentration. Biomed Eng Online. 2020 May 29;19(1):40. doi: 10.1186/s12938-020-00784-1.