Efficacy and potential mechanism of transcutaneous auricular vagus nerve stimulation on depressive symptoms and attention after stroke

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2400084576

Enrollment

Unknown

Registered

2024-05-21

Start date

2024-06-01

Completion date

Unknown

Last updated

2024-05-27

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

Conditions

Stroke

Interventions

Test Group:Treatment plan: Transcutaneous vagal nerve stimulation for 30 minutes, once a day in the morning and afternoon. Stimulation equipment: a silver round electrode with a diameter of about 5mm

preparation before stimulation: wipe the stimulation site with alcohol. Stimulation parameters: frequency: 25Hz

pulse width: 200 microseconds

rise time: 2s

fall time: 2s

stimulation time: 30s

interval time: 30s. Current intensity: the maximum stimulation intensity that the patient can tolerate (maximum not exceeding 10mA)

sham stimulation uses earlobe electrical stimulation. Stimulation site: left tragus and concha area.

Sham Stimulation Group:Treatment plan: Transcutaneous vagal nerve stimulation for 30 minutes, once a day in the morning and afternoon. Stimulation equipment: a silver round electrode with a diameter

sham stimulation uses earlobe electrical stimulation. Stimulated area: earlobe

Eligibility

Sex/Gender

All

Age

35 Years to 80 Years

Inclusion criteria

Inclusion criteria: (1) Male or female aged 35~80 years old; (2) Eligible for the diagnosis of stroke (cerebral hemorrhage, cerebral infarction) within 6 months, confirmed by head CT or MR diagnosis; (3) Hamilton Depression 17-item Rating Scale (HAMD17) = 16 points; (4) Those who can cooperate with taVNS treatment; (5) Those who can understand the purpose of the study, cooperate with the study, and sign the informed consent form

Exclusion criteria

Exclusion criteria: (1) Patients with vascular dementia and severe aphasia; (2) Patients with major depression before stroke; (3) Stroke with severe psychiatric symptoms (frontal stroke); (4) Serious damage to heart, liver, kidney and lung function

Design outcomes

Primary

Measure	Time frame
Hamilton Depression Scale-17;	—

Secondary

Measure	Time frame
Stroop Color Word Test response time, accuracy rate;Modified Barthel ;Working Memory response time, accuracy rate;	—

Countries

China

Contacts

Public ContactGui Yunjie

Wuxi Mental Health Center, Jiangsu Province

674990336@qq.com+86 150 5226 8032

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Jul 26, 2026