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Efficacy and Safety of Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) for Elderly Patients with Depression and Prefrontal Executive Dysfunction

Efficacy and Safety of Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) for Elderly Patients with Depression and Prefrontal Executive Dysfunction

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600130894
Enrollment
Unknown
Registered
2026-08-26
Start date
2026-03-07
Completion date
Unknown
Last updated
2026-08-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Late-life Depression

Interventions

Trial Group:Ranscutaneous Auricular Vagus Nerve Stimulation

Sponsors

Chongqing Mental Health Center
Lead Sponsor

Eligibility

Sex/Gender
All
Age
60 Years to 85 Years

Inclusion criteria

Inclusion criteria: 1. Aged >= 60 years, right-handed, regardless of gender; 2. Meeting the diagnostic criteria for depressive disorders as defined in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5); 3. No antidepressant treatment during the current episode, or antidepressant use for less than 7 days in the recent 14 days; 4. A score of >= 17 points on the 17-item Hamilton Depression Rating Scale (HAMD-17) (indicating moderate depression or above); 5. A score below one standard deviation or more compared with the normal control group in at least one of the Trail Making Test Part A (TMT-A) and Trail Making Test Part B (TMT-B); 6. A score of > 20 points on the Mini-Mental State Examination (MMSE) for patients with primary school education, and > 24 points on the MMSE for patients with junior high school education or above; 7. Having an education level of primary school or above, and being able to understand the content of the scales and tests; 8. Providing written informed consent by the patients themselves.

Exclusion criteria

Exclusion criteria: 1. A history of or current diagnosis of cranial diseases, brain injury, epileptic seizures, or other neurological disorders; 2. A history of or current diagnosis of severe or unstable diseases of the cardiovascular, respiratory, immune, or other systems; patients with critical conditions or organ failure of major importance; 3. A history of or current diagnosis of the following psychiatric disorders as defined by the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5): organic mental disorders, Alzheimer’s disease, secondary dementia due to other causes, schizophrenia, schizoaffective disorder, bipolar disorder, delusional disorder, unspecified mental disorders, alcohol (or drug) dependence or abuse, and personality disorders; 4. Patients with a high risk of suicide; 5. Presence of contraindications to transcutaneous auricular vagus nerve stimulation (taVNS), such as severe allergy to electrode patches, local skin damage or inflammation, and hyperalgesia in the stimulation area; 6. Subjects;

Design outcomes

Primary

MeasureTime frame
TMT-A/B score;HAMD-17 score;Color word Stroop task;

Secondary

MeasureTime frame
Montreal Cognitive Assessment Scale (MoCA;Functional near - infrared spectroscopy;

Countries

China

Contacts

Public ContactLiu Shengyan

Chongqing Mental Health Center

734077291@qq.com+86 23 67171137

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Sep 19, 2026