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Observation and mechanism of transcutaneous auricular vagus nerve stimulation in the treatment of limb motor dysfunction after ischemic stroke

Observation and mechanism of transcutaneous auricular vagus nerve stimulation in the treatment of limb motor dysfunction after ischemic stroke

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300068006
Enrollment
Unknown
Registered
2023-02-02
Start date
2023-02-02
Completion date
Unknown
Last updated
2023-05-15

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

Conditions

cerebral arterial thrombosis

Interventions

The taVNS group:Transcutaneous aural vagus nerve stimulation +Basic treatment+rehabilitation treatment
The sham taVNS group:taVNS stimulates the vagus-rich region of the left auricular tail + Basic treatment+rehabilitation treatment
Routine rehabilitation group:Basic treatment+rehabilitation treatment

Sponsors

The Seventh People's Hospital affiliated to Shanghai University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
35 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. 35 <= 75 years old; 2. Stroke (infarction) occurred for the first time, in the recovery period (course of the disease from 2 months to 6 months), basically stable, unconscious disorder, no obvious language disorder; 3. The diagnosis conforms to the key points of cerebrovascular disease diagnosis adopted by the fourth National Academic Conference on Cerebrovascular Disease in 1995; 4. Unilateral subcortical cerebral infarction (basal ganglia, thalamus, internal capsule, etc.) confirmed by head CT or MRI; 5. Brunnstrom grade of the affected hand 0-3; 6. There is no metal implant or pacemaker in the body; 7. No previous history of epilepsy or clear cognition does not affect communication and assessment; 8. Informed consent signed by the patient himself or by his immediate family member.

Exclusion criteria

Exclusion criteria: 1. Cerebrovascular disease has been present for more than 6 months, or the disease is progressing in the acute phase or the vital signs are unstable; Examination confirmed that there are cerebral hemorrhage, brain trauma, brain tumor, cerebellum and brain stem lesions can cause motor dysfunction and other encephalopathy; 2. If the disease really needs other acupuncture (such as head acupuncture, body acupuncture, etc.) treatment; 3. Exclude bone diseases, joint injuries, or fixed contraction affecting limb deformities, etc.; 4. Cognitive dysfunction is so severe that it is impossible to carry out relevant training and assessment of this subject; 5. Patients with serious diseases of the heart, liver, kidney, endocrine system, and hematopoietic system; 6. Pregnant and lactating women; 7. Those who are participating in other clinical trials that affect the evaluation of the results of this study.

Design outcomes

Primary

MeasureTime frame
WOLF Motor Function Assessment Scale;Fugl-Meyer scale;

Secondary

MeasureTime frame
Function Independent Measure, FIM;The SF-36 scale;

Countries

China

Contacts

Public ContactTiantian Liu

The Seventh People's Hospital affiliated to Shanghai University of Traditional Chinese Medicine

tiantianliu66@163.com+86 188 4505 9205

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026