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Trial Title:
Efficacy, Safety and Neural Mechanism of Stellate Ganglion Block in the Treatment of Anxiety. Disorder.
NCT ID:
NCT06540313
Condition:
Anxiety Disorders
Stellate Ganglion Block
Conditions: Official terms:
Ganglion Cysts
Synovial Cyst
Anxiety Disorders
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Factorial Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
Stellate Ganglion Block
Description:
Stellate ganglion block refers to the injection of local anesthetic drugs into tissues
around and near SG to regulate the tension of the sympathetic nervous system, inhibit the
outflow of the sympathetic nerve in the innervation area of the stellate ganglion to the
ipsilateral head, neck, chest and upper limb, and finally achieve the role of regulating
the autonomic nervous system, circulatory system, endocrine system and immune system of
the human body to maintain dynamic balance. It is used to treat a variety of pain and
non-pain diseases.
Arm group label:
Explore the Stellate Ganglion Block intervention mechanism
Arm group label:
Relieve anxiety symptoms
Arm group label:
Restore mental function
Arm group label:
Verify Stellate Ganglion Block security
Summary:
1. In this study, ultrasound-guided Stellate Ganglion Block(SGB) will be used in the
treatment of anxiety disorders, combined with relevant scales, HRV indicators and
resting state functional magnetic resonance data, to explore the safety and
effectiveness of SGB in the treatment of anxiety disorders, and to explore whether
its mechanism of action is related to the excitability of sympathetic nervous system
and the activity changes of insular cortex.
2. Verify the following hypothesis:
(1) SGB is a safe, well-tolerated and acceptable treatment technique; (2) After SGB
treatment, the anxiety symptoms of the patients were relieved to a certain extent and the
psychological function was restored; (3) The sympathetic excitability of patients after
SGB treatment is reduced, and this effect can be monitored by heart rate variability; (4)
The activity of insular cortex decreased after SGB treatment.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Aged 18-60 years old
2. Diagnosed with various types of anxiety disorders according to the DSM-5, and meet
the diagnostic criteria for pain disorders
3. Right-handed
4. Voluntarily join the study and sign the informed consent.
Exclusion Criteria:
1. Suicidal thoughts and behaviors
2. serious physical disease
3. diseases of the nervous system or other mental diseases
4. Contraindications for MRI examination
5. During pregnancy or lactation
6. Allergy to narcotic drugs
7. Contraindications with stellate ganglion block
Gender:
All
Minimum age:
18 Years
Maximum age:
60 Years
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Nanjing Brain Hospital
Address:
City:
Nanjing
Zip:
210029
Country:
China
Start date:
September 1, 2024
Completion date:
June 10, 2026
Lead sponsor:
Agency:
Nanjing Medical University
Agency class:
Other
Source:
Nanjing Medical University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06540313
