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Observation on rehabilitation effects of transcuta neous auricular vagus never stimulation on patients with chronic ischemic stroke

Observation on rehabilitation effects of transcutaneous auricular vagus never stimulation on patients with chronic ischemic stroke

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300068033
Enrollment
Unknown
Registered
2023-02-03
Start date
2023-02-01
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

chronic ischemic stroke

Interventions

Combination of vagus nerve and rehabilitation 1 group:30Hz taVNS
Combination of vagus nerve and rehabilitation 2 groups:300Hz taVNS
Combination of vagus nerve and rehabilitation 3 groups:3000Hz taVNS
Control group:sham stimulation

Sponsors

Shanghai Yangzhi Rehabilitation Hospital(Shanghai sunshine Rehabilitation Center)
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. It meets the diagnostic criteria of stroke in the diagnostic points of various cerebrovascular diseases and is confirmed by brain CT or MRI examination; 2. Patients with the first onset and the course of disease within 9 months are stable after acute treatment; 3. Upper limb motor dysfunction; 4. The cognitive function of patients is clear and they have the ability to give informed consent and understand instructions; 5. The study was approved by the Medical Ethics Committee and the informed consent of the patients or their families.

Exclusion criteria

Exclusion criteria: 1. Hemorrhagic stroke; 2. Surgical intervention has been performed on the vagus nerve in the past; 3. Sinus bradycardia (HR < 60 bpm); 4. Cognitive impairment or any significant decline in alternate language reception or attention may affect the understanding of motor test instructions; 5. Limb apraxia; 6. Excessive pain in any joint of paralyzed limb; 7. Advanced liver, kidney, heart, or lung diseases; 8. History of serious alcoholism or drug abuse; 9. Depression or use of neuropsychiatric drugs such as antidepressants or benzodiazepines; 10. Botulinum toxin injection or any other non-research active upper limb rehabilitation 12 weeks before or during treatment; 11. Pregnancy.

Design outcomes

Primary

MeasureTime frame
Fugl-Meyer, FMA;

Secondary

MeasureTime frame
Modified Barthel Index, MBI;Modified Ashworth Scale, MAS;Hamilton Depression Scale, HAMD;

Countries

China

Contacts

Public ContactBin Yu

Shanghai Yangzhi Rehabilitation Hospital(Shanghai sunshine Rehabilitation Center)

yubin@tongji.edu.cn+86 139 1810 8880

Outcome results

None listed

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