Skip to content

Study on neural mechanism and auricular acupoint vagus nerve stimulation based on brainstem-hypothalamus-insula pathway in interoceptive abnormality in migraine

Study on neural mechanism and auricular acupoint vagus nerve stimulation based on brainstem-hypothalamus-insula pathway in interoceptive abnormality in migraine

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400092467
Enrollment
Unknown
Registered
2024-11-18
Start date
2024-11-20
Completion date
Unknown
Last updated
2024-12-02

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

Conditions

migraine

Interventions

A group: 1Hz, 20Hz, 100Hz:For transcutaneous auricular vagus nerve stimulation, the pancreaticobiliary and lung acupoints in the left concha are the stimulation points. The stimulation frequency is 1H
B group: 20Hz, 100Hz, 1Hz:For transcutaneous auricular vagus nerve stimulation, the pancreaticobiliary and lung acupoints in the left concha are the stimulation points. The stimulation frequency is 1H
C group: 100Hz, 1Hz, 20Hz:For transcutaneous auricular vagus nerve stimulation, the pancreaticobiliary and lung acupoints in the left concha are the stimulation points. The stimulation frequency is 1H
Real taVNS group:The pancreaticobiliary and lung points in the left concha are used as stimulation points. The taVNS frequency that has the best effect on improving interoceptive abnormalities in the
Sham taVNS group:The two acupoints on the wrist and shoulder of the left auricular scaphoid were used as stimulation points, and the other parameters were the same as those in the true taVNS group.
healthy control group:no intervention

Sponsors

Beijing University of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1.Meet the diagnostic criteria for migraine without aura; 2.Age 18-70 years old; 3.Headache attacks occurred no less than 6 times in the 3 months before treatment and at least once per month; 4.They have not taken any psychotropic or vasoactive drugs during the past 3 months, received electroacupuncture or other preventive treatments during the past 1 month, and taken long-term analgesic drugs; 5.Hamilton Depression Rating Scale (24-item version) score of 35 or less (no major depression); 6.Hamilton Anxiety Rating Scale (14-item version) score below 21 (no significant anxiety); 7.Right-handed and without contraindications to MRI; 8.Informed consent was obtained and voluntary participation was given.

Exclusion criteria

Exclusion criteria: 1.Other primary and secondary headaches; 2.Combined with organic digestive system diseases and/or malignant tumors; 3.Suffering from severe organ failure, serious cardiovascular and cerebrovascular diseases, or musculoskeletal system diseases; 4.Mentally abnormal, incapable of independent behavior, and unwilling to cooperate with clinical observation and treatment; 5.Alcohol abusers; 6.Those with bleeding tendencies; 7.Those with abnormalities in written and oral communication; 8.People with claustrophobia or other conditions that are not suitable for MRI examination.

Design outcomes

Primary

MeasureTime frame
frequency of migraine attacks;pain intensity;Multidimensional Assessment of Interoceptive Awareness-2 , MAIA-2;Interoceptive Accuracy Scale,IAS;Interoceptive Attention Scale,IATS;

Secondary

MeasureTime frame
Body Perception Questionnaire-Short Form,BPQ-SF;migraine specific quality-of-life questionnaire,MSQOL;State-Trait Anxiety Inventory,STAI;Beck Depression Inventory,BDI;Pittsburgh Sleep Quality Index,PSQI;Headache Impact Test-6,HIT-6;

Countries

China

Contacts

Public ContactCao Jin

Beijing University of Chinese Medicine

caojin@bucm.edu.cn+86 139 0110 8316

Outcome results

None listed

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