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Active, Not Recruiting

NCT Number: NCT06794034

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

The purpose of this study is to compare the efficacy of taVNS versus sham stimulation in reduing depressive symptoms in patients with epilepsy.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Depressive Symptoms in Patients With Epilepsy Behavior Behavioral Symptoms Brain Diseases Central Nervous System Diseases Depression Epilepsy Nervous System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Second Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou, Zhejiang, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intervention

Device

taVNS 25Hz+routine treatment, three times daily, 30 mins

Sham Comparator

Device

taVNS 1Hz+routine treatment, three times daily, 30 mins

Primary outcomes

  1. 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

Secondary outcomes

  1. Depression remission proportion

    Time frame: at 20th week

    depression remission proportion=(number of remission patients/total number of group patients)*100%, depression remission defined as HAMD-17 scores ≤ 7

  2. Anxiety

    Time frame: 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.

  3. Seizure frequency

    Time frame: at 20th week

    change from baseline in seizure frequency (times per week)

  4. Seizure severity

    Time frame: 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

  5. Sleep quality

    Time frame: 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.

  6. Suicidality

    Time frame: 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.

  7. Quality of life

    Time frame: 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.

  8. Adverse events

    Time frame: at 4th 、8th、12th、16th、20th 、22th week

    patient-reported adverse events

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Other

Collaborators

  • First Affiliated Hospital of Zhejiang University
  • Jinhua Second Hospital
  • Ningbo Medical Center Lihuili Hospital
  • The Fourth Affiliated Hospital of Zhejiang University School of Medicine

Registry information

Acronym: TIDES

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jan 27, 2025
Registry last updated
Jan 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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