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| Name | Class |
|---|---|
| The Fourth Affiliated Hospital of Zhejiang University School of Medicine | OTHER |
| Ningbo Medical Center Lihuili Hospital | OTHER_GOV |
| First Affiliated Hospital of Zhejiang University | OTHER |
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The purpose of this study is to compare the efficacy of taVNS versus sham stimulation in reduing depressive symptoms in patients with epilepsy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| "xinlepai","taVNS" 25Hz | Experimental | The "xinlepai", a transcutaneous auricular vagus nerve stimulator (taVNS), was used with a stimulation frequency of 25Hz, combined with conventional treatment. Use 3 times daily for 30 minutes each time. |
|
| "xinlepai","taVNS" 1Hz | Sham Comparator | The "xinlepai", a transcutaneous auricular vagus nerve stimulator (taVNS), was used with a stimulation frequency of 1Hz, combined with conventional treatment. Use 3 times daily for 30 minutes each time. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intervention | Device | taVNS 25Hz+routine treatment, three times daily, 30 mins |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Depression response proportion | depression response proportion=(number of responders/total number of group patients)*100%, depression response defined as ≥50% reduction in HAMD-17 scores at 20th week | at 20th week |
| Measure | Description | Time Frame |
|---|---|---|
| Depression remission proportion | depression remission proportion=(number of remission patients/total number of group patients)*100%, depression remission defined as HAMD-17 scores ≤ 7 | at 20th week |
| Anxiety |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| yi guo | Second Affiliated Hospital, School of Medicine, Zhejiang University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Second Affiliated Hospital, School of Medicine, Zhejiang University | Hangzhou | Zhejiang | 310009 | China | ||
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| Jinhua Second Hospital | UNKNOWN |
Intervention arm: taVNS 25Hz+routine treatment, three times daily, 30 mins Sham arm: taVNS 1Hz+routine treatment, three times daily, 30 mins
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The device provider assigns the device directly to the patient for training and use after allocation. All the scales will be assessed by the same site assessor, who has undergone consistency training. The doctors, patients, scale assessors and statisticians are all blinded.
| Sham Comparator |
| Device |
taVNS 1Hz+routine treatment, three times daily, 30 mins |
|
Changes in the 14-item Hamilton Anxiety Scale (HAMA-14) score from baseline.The total score of the HAMA-14 ranges from 0 to 56, with the higher the score, the more serious the anxiety.
| at 20th week |
| Seizure frequency | change from baseline in seizure frequency (times per week) | at 20th week |
| Seizure severity | change from baseline in Liverpool Seizure Severity Scale (LSSS) scores.The total score of the LSSS ranges from 0 to 11 points, and the higher the score, the higher the severity of seizures | at 20th week |
| Sleep quality | change from baseline in Pittsburgh Sleep Quality Index (PSQI) scores.The total score of PSQI ranges from 0 to 21, with the higher the score, the worse the sleep quality. | at 20th week |
| Suicidality | change from baseline in the Mini-International Neuropsychiatric Interview (MINI) Suicide Risk Module scores.The MINI Suicide Risk Module has an overall score ranging from 0 to 33, with higher scores associated with higher suicide risk. | at 20th week |
| Quality of life | change from baseline in quality of life in epilepsy inventory-31 scale, which has a total of 31 items divided into 7 aspects and 1 overall entry, the higher the score, the higher the quality of life. | at 20th week |
| Adverse events | patient-reported adverse events | at 4th 、8th、12th、16th、20th 、22th week |
| The First People's Hospital of Jiaxing |
| Jiaxing |
| Zhejiang |
| 314000 |
| China |
| Jinhua Second Hospital | Jinhua | Zhejiang | 321000 | China |
| Ningbo Medical Center Li Huili Hospital | Ningbo | Zhejiang | 315040 | China |
| The Fourth Affiliated Hospital, School of Medicine, Zhejiang University | Yiwu | Zhejiang | 322000 | China |
| ID | Term |
|---|---|
| D004827 | Epilepsy |
| D003863 | Depression |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D008722 | Methods |
| ID | Term |
|---|---|
| D008919 | Investigative Techniques |
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