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The Effects and Mechanisms of Transcutaneous Auricular Vagus Nerve Stimulation on Cognitive Function in Patients with Early Traumatic Brain Injury

The Effects and Mechanisms of Transcutaneous Auricular Vagus Nerve Stimulation on Cognitive Function in Patients with Early Traumatic Brain Injury

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400089924
Enrollment
Unknown
Registered
2024-09-19
Start date
2024-10-01
Completion date
Unknown
Last updated
2024-09-23

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

Conditions

Cognitive Dysfunction After Craniocerebral Injury

Interventions

tVNS(Transcutaneous vagal nerve stimulation group ):The stimulation device provides stimulation according to normal stimulation parameters.Stimulation Frequency: 25Hz Pulse Width: 500?microseconds Sti
Sham stimulation group:Participants will use a sham stimulation device. The device is programmed to stimulate only during the first 20 seconds
after 20 seconds, the device automatically turns off.

Sponsors

People's Liberation Army The General Hospital of Western Theater Command Chengdu, Sichuan
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Subjects must meet the following conditions: (1)Age between 18 and 65 years, no gender limitation, diagnosed with mild to moderate closed craniocerebral injury, injury occurred within one week, Glasgow Coma Scale (GCS) score =9. (2)HAMD and HAMA scores (depression scales) are both less than 7 points

Exclusion criteria

Exclusion criteria: Subjects will be excluded from this study if they meet any of the following criteria: 1. Neurological diseases that may lead to cognitive decline, including a history of open craniocerebral injury, intracranial infection, cerebrovascular disease, encephalitis, brain tumor, epilepsy, Parkinson's disease, Alzheimer's disease, white matter lesions, etc. 2. Metabolic diseases that may cause cognitive decline, such as anemia, thyroid dysfunction, folic acid and vitamin B12 deficiencies, etc. 3. Severe mental illnesses, such as severe depression or a history of gas poisoning. 4. History of general anesthesia within the past three months. 5. History of ear trauma, skin diseases, or other conditions that prevent wearing the stimulator. 6. Acute or severe life-threatening diseases. 7. Severe visual, hearing, or language problems that prevent completion of neuropsychological assessments. 8. Contraindications to transcutaneous vagus nerve stimulation (tVNS), such as implanted devices like cardiac pacemakers.

Design outcomes

Primary

MeasureTime frame
Montreal Cognitive Assessment Scale (MoCA-B);

Secondary

MeasureTime frame
Simple intelligent mental state Examination Scale;Galvis orientation and memory forgetting test scale;Functional activities of daily living scale;Electroencephalogram;Head Computed Tomography;Blood inflammatory factors ,Interleukin-6;Interleukin-10;Tumor Necrosis Factor-alpha;

Countries

China

Contacts

Public ContactSHU HAIFENG

People's Liberation Army The General Hospital of Western Theater Command Chengdu, Sichuan

shuhaifeng@swjtu.edu.cn+86 139 0805 2010

Outcome results

None listed

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