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Exploring the brain mechanisms of transcutaneous auricular vagus nerve stimulation for patients with insomnia based on multimodal magnetic resonance imaging

Investigate the clinical efficacy and central brain mechanisms of transcutaneous auricular acupoint vagus nerve stimulation in the treatment of patients with insomnia disorder based on multimodal MRI

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2100005324
Enrollment
Unknown
Registered
2021-09-20
Start date
2021-10-10
Completion date
Unknown
Last updated
2023-02-20

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

Conditions

Insomnia Disorder

Interventions

Sham-taVNS Group:Sham-taVNS
taVNS Group:taVNS
NC Group:No

Sponsors

Institute of Acupuncture and Moxibustion, China Academy of Chinese Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1) Conformity to the diagnostic standards of the American Diagnostic and Statistical Manual of Mental Disorders (5th edition) for PI. 2) Insomnia symptoms lasting for > 3 months, =3 times per week. 3) 18 to 70 years old, right-handed. 4) Pittsburgh sleep quality index (PSQI) score=8,17 items of the Hamilton Depression Scale =17 and 14 items of the Hamilton Anxiety Scale =14. 5) Not taking any neuropsychiatric medications or substances and not receiving acupuncture treatment in the past month. 6) Cooperate to accept the treatment of auricular electrical stimulation and complete the acquisition of magnetic resonance data. 7) Signed the informed consent form..

Exclusion criteria

Exclusion criteria: 1) Patients with severe physical diseases, such as coronary heart disease, malignant tumor and renal failure. 2) Patients with brain organic diseases. 3) Combined with any other mental disorder, personality disorder or psychoactive substance abuse or dependence. 4) Patients who cannot elute from medicine or acupuncture treatment. 5) Pregnant and lactating women. 6) Patients with contraindications of magnetic resonance imaging (MRI). 7)Patients with damaged ear skin. 8)Patients who were unwilling to sign inform consent.

Design outcomes

Primary

MeasureTime frame
MRI;PSQI;—

Secondary

MeasureTime frame
ISI;FFS;HAMA-14;ESS;HAMD-17;—

Countries

China

Contacts

Public ContactRong PeiJing

Institute of Acupuncture and Moxibustion, China Academy of Chinese Medical Sciences

drrongpj@163.com13718482149

Outcome results

None listed

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