Depressive Symptoms in Patients With EpilepsyTIDESNCT06794034
Efficacy of taVNS Versus Sham Stimulation in Reduing Depressive Symptoms in Patients With Epilepsy: a Multi-center, Double-blinded, Randomized, 20-week, Parallel-arm, Superiority Study
A study testing Intervention in people with Depressive Symptoms in Patients With Epilepsy, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 5 sites in China.
Trial summary
The purpose of this study is to compare the efficacy of taVNS versus sham stimulation in reduing depressive symptoms in patients with epilepsy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depressive Symptoms in Patients With Epilepsy
- What is being tested?
- Intervention
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 158 participants
- Where
- 5 sitesChina
- Study dates
- 1 Apr 2023to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
China5 sites
The Second Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, 310009
The First People's Hospital of Jiaxing
Jiaxing, Zhejiang, 314000
Jinhua Second Hospital
Jinhua, Zhejiang, 321000
Ningbo Medical Center Li Huili Hospital
Ningbo, Zhejiang, 315040
The Fourth Affiliated Hospital, School of Medicine, Zhejiang University
Yiwu, Zhejiang, 322000
About this study
The purpose of this study is to compare the efficacy of taVNS versus sham stimulation in reduing depressive symptoms in patients with epilepsy.
- Being tested
- Intervention, Sham Comparator
- Keywords
- transcutaneous auricular vagus nerve stimulation, epilepsy, depression
- Medical subject headings
- Epilepsy, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InterventionDevice
taVNS 25Hz+routine treatment, three times daily, 30 mins
Sham ComparatorDevice
taVNS 1Hz+routine treatment, three times daily, 30 mins
| Study group | Role | What they receive |
|---|---|---|
| "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. Receives: Device: Intervention |
| "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. Receives: Device: Sham Comparator |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: at 20th week
Secondary outcomes (8)
Depression remission proportion
depression remission proportion=(number of remission patients/total number of group patients)*100%, depression remission defined as HAMD-17 scores ≤ 7
Measured: at 20th week
Anxiety
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.
Measured: at 20th week
Seizure frequency
change from baseline in seizure frequency (times per week)
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: at 20th week
Adverse events
patient-reported adverse events
Measured: at 4th 、8th、12th、16th、20th 、22th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2025
- Study start1 Apr 2023
- Primary completion30 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depressive Symptoms in Patients With EpilepsyStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Intervention arm: taVNS 25Hz+routine treatment, three times daily, 30 mins Sham arm: taVNS 1Hz+routine treatment, three times daily, 30 mins
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 158 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- The Fourth Affiliated Hospital of Zhejiang University School of Medicine, Ningbo Medical Center Lihuili Hospital, First Affiliated Hospital of Zhejiang University, Jinhua Second Hospital
- Responsible party
- Sponsor
- Investigators
- yi guo, Principal investigator, Second Affiliated Hospital, Zhejiang University, School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06794034
- Sponsor's protocol ID
- 2023-0182
- Acronym
- TIDES
- Status last verified
- Nov 2024
- First submitted
- 17 Nov 2024
- Last updated
- 27 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of taVNS Versus Sham Stimulation in Reduing Depressive Symptoms in Patients With Epilepsy: a Multi-center, Double-blinded, Randomized, 20-week, Parallel-arm, Superiority Study
- ClinicalTrials.gov ID
- NCT06794034
- Acronym / sponsor ID
- TIDES / 2023-0182
- Keywords
- transcutaneous auricular vagus nerve stimulation, epilepsy, depression
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 158 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Collaborators
- The Fourth Affiliated Hospital of Zhejiang University School of Medicine, Ningbo Medical Center Lihuili Hospital, First Affiliated Hospital of Zhejiang University, Jinhua Second Hospital
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 27 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to compare the efficacy of taVNS versus sham stimulation in reduing depressive symptoms in patients with epilepsy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Intervention arm: taVNS 25Hz+routine treatment, three times daily, 30 mins Sham arm: taVNS 1Hz+routine treatment, three times daily, 30 mins
| Arm | Type | Receives |
|---|---|---|
| "xinlepai","taVNS" 25Hz | Experimental | Device: InterventionThe "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 | Device: Sham ComparatorThe "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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| InterventiontaVNS 25Hz+routine treatment, three times daily, 30 mins | Device | "xinlepai","taVNS" 25Hz |
| Sham ComparatortaVNS 1Hz+routine treatment, three times daily, 30 mins | Device | "xinlepai","taVNS" 1Hz |
Primary outcome
Depression response proportion
Time frame: 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
8 secondary outcomes
Depression remission proportion
Time frame: at 20th week
Anxiety
Time frame: at 20th week
Seizure frequency
Time frame: at 20th week
Seizure severity
Time frame: at 20th week
Sleep quality
Time frame: at 20th week
Suicidality
Time frame: at 20th week
Quality of life
Time frame: at 20th week
Adverse events
Time frame: at 4th 、8th、12th、16th、20th 、22th week
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2025.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
yi guo principal investigator
Second Affiliated Hospital, Zhejiang University, School of Medicine
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention in people with Depressive Symptoms in Patients With Epilepsy, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 5 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 27 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Depression response proportion (time frame: at 20th week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2025.