Depressive Symptoms in Patients With Epilepsy
Conditions
Keywords
transcutaneous auricular vagus nerve stimulation, epilepsy, depression
Brief summary
The purpose of this study is to compare the efficacy of taVNS versus sham stimulation in reduing depressive symptoms in patients with epilepsy.
Interventions
DEVICEIntervention
taVNS 25Hz+routine treatment, three times daily, 30 mins
DEVICESham Comparator
taVNS 1Hz+routine treatment, three times daily, 30 mins
Sponsors
The Fourth Affiliated Hospital of Zhejiang University School of Medicine
Ningbo Medical Center Lihuili Hospital
First Affiliated Hospital of Zhejiang University
Jinhua Second Hospital
Second Affiliated Hospital, School of Medicine, Zhejiang University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
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.
Intervention model description
Intervention arm: taVNS 25Hz+routine treatment, three times daily, 30 mins Sham arm: taVNS 1Hz+routine treatment, three times daily, 30 mins
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adults age ≥18 * Confirmed diagnosis of epilepsy (based on 2014 definition by ILAE) * Having comorbidity with mild-moderate depression (confirmed diagnosis by a psychiatrist) * Willing and able to provide informed conset
Exclusion criteria
* Those experiencing status epilepticus or frequent seizures requiring emergency medication within the year prior to recruitment * Those with severe depression or anxiety who are in urgent need of psychiatric care * Those who are imminently suicidal or unable to keep themselves safe * Those experiencing severe cognitive difficulties with day-to-day memory, attention, and ability to learn basic information * Those having a pacemaker, a invasive vagus nerve stimulator, or a metal implant * The pinna is not suitable for earplugs * Pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Depression response proportion | at 20th week | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Anxiety | at 20th week | 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. |
| Seizure frequency | at 20th week | change from baseline in seizure frequency (times per week) |
| Seizure severity | at 20th week | 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 |
| Depression remission proportion | at 20th week | depression remission proportion=(number of remission patients/total number of group patients)\*100%, depression remission defined as HAMD-17 scores ≤ 7 |
| Suicidality | at 20th week | 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. |
| Quality of life | at 20th week | 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. |
| Adverse events | at 4th 、8th、12th、16th、20th 、22th week | patient-reported adverse events |
| Sleep quality | at 20th week | 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. |
Countries
China
Outcome results
None listed