Refractory Epilepsy
Conditions
Keywords
PINS VNS Refractory Epilepsy
Brief summary
Evaluate the long-term clinical effectiveness and safety of the PINS vagus nerve stimulator to patients with refractory epilepsy.
Interventions
DEVICEVagus Nerve Stimulation
Vagus Nerve Stimulator
Sponsors
Beijing Tiantan Hospital
Beijing Pins Medical Co., Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
6 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in seizure frequency from baseline to the seizure count evaluvation period 6 month | 4,8,12,16,20,24 months of stimulation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in seizure frequency from baseline to the seizure count evaluvation period | 4,8,12,16,20,24 months of stimulation | Changes in seizure frequency from baseline to 4,8,12,16,20,24 months |
| 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 12,24 months | QOLIE-31 contains 7 multi-item scales that tap the following health concepts:overall quality of life, emotional well-being, social functioning, energy/fatigue, worry about seizure,cognitive functioning,medication effects. Range of values 0-100. Higher scores reflect better quality of life; lower ones, worse quality of life. |
| Changes in the Number of Anti-epileptic Drugs Prescribed | At12,24 months | Changes in Anti-Epileptic Drugs (AEDs) in patients with less then a 50% reduction in seizures |
| Changes from Basline in the Engel and McHugh description | At 12,24 months | — |
| Changes from Basline in 24 hour ECG description | At 12,24 months | — |
Countries
China
Contacts
Primary ContactJia Fumin, PhD
Backup ContactLi Luming, PhD
Outcome results
None listed