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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
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100051319
Enrollment
Unknown
Registered
2021-09-20
Start date
2021-10-10
Completion date
Unknown
Last updated
2022-11-20

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

Conditions

Insomnia Disorder

Interventions

therapy group:Auricular vagus nerve stimulation

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. Meet the diagnostic criteria of DSM-5 insomnia disorder in the Diagnostic and Statistical Manual of Mental Disorders Fifth Edition; 2. Insomnia symptoms persist for >3 months, >=3 times a week; 3. Age 18-70 years old, right-handed; 4. Pittsburgh Sleep Quality Index (PSQI) scale score >= 8 points, 17-item Hamilton Depression Scale <= 17 points and 14-item Hamilton Anxiety Scale <= 14 points; 5. Have not taken any drugs or substances that act on the nervous system in the past 1 month, and have not received acupuncture treatment; 6. Able to accept the treatment of ear electrical stimulation, and can cooperate with the acquisition of magnetic resonance data; 7. Sign the informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients with serious physical diseases, such as coronary heart disease, malignant tumor, renal failure, etc.; 2. Patients with organic brain diseases; 3. Combining with any other mental disorder, personality disorder or psychoactive substance abuse or dependence; 4. Those who cannot be eluted by using drugs or acupuncture; 5. Pregnant and lactating women; 6. There are contraindications to MRI examination; 7. Those with damaged ear skin.

Design outcomes

Primary

MeasureTime frame
Pittsburgh sleep quality index,PSQI;MRI;

Secondary

MeasureTime frame
Insomnia severity score;17-item Hamilton Depression Scale score;14-item Hamilton Anxiety Scale score;Epworth Sleepiness Scale;Flinders Fatigue Scale;

Countries

China

Contacts

Public ContactRong Peijing

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

drrongpj@163.com+86 13718482149

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 5, 2026