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| Name | Class |
|---|---|
| Beijing Tiantan Hospital | OTHER |
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Evaluate the long-term clinical effectiveness and safety of the PINS vagus nerve stimulator to patients with refractory epilepsy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vagus Verve Stimulation is on | Experimental |
| |
| Placebo Vagus Verve Stimulation is off | Sham Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vagus Nerve Stimulation | Device | Vagus Nerve Stimulator |
|
| Measure | Description | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in seizure frequency from baseline to the seizure count evaluvation period | Changes in seizure frequency from baseline to 4,8,12,16,20,24 months | 4,8,12,16,20,24 months of stimulation |
| Overall Quality of Life in Epilepsy-31 (QOLIE-31) Score in Patients With Baseline & at Least One Post-baseline QOLIE Assessment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jia Fumin, PhD | Contact | +86 010-59361265 | pins_medical@163.com | |
| Li Luming, PhD | Contact | +86 010-60736388 |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Tiantan Hospital | Recruiting | Beijing | Beijing Municipality | 100050 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32471438 | Derived | 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. |
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| ID | Term |
|---|---|
| D000069279 | Drug Resistant Epilepsy |
| ID | Term |
|---|---|
| D004827 | Epilepsy |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D055536 | Vagus Nerve Stimulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
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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. |
| Mean change from baseline QOLIE-31 Overall Score at 12,24 months |
| Changes in the Number of Anti-epileptic Drugs Prescribed | Changes in Anti-Epileptic Drugs (AEDs) in patients with less then a 50% reduction in seizures | At12,24 months |
| 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 |
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