Efficacy, Safety and Neural Mechanism of Stellate Ganglion Block in the Treatment of Anxiety. Disorder.

Nanjing Medical University

Status: Not yet enrolling

Conditions: Stellate Ganglion Block; Anxiety Disorders

Treatments: Other: Stellate Ganglion Block

Study type: Interventional

Funder types: Other

Identifiers

NCT06540313

SGB-KY-2024

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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60 participants in 4 patient groups

Relieve anxiety symptoms

Experimental group

Treatment:

Other: Stellate Ganglion Block

Restore mental function

Experimental group

Treatment:

Other: Stellate Ganglion Block

Verify Stellate Ganglion Block security

Experimental group

Treatment:

Other: Stellate Ganglion Block

Explore the Stellate Ganglion Block intervention mechanism

Experimental group

Treatment:

Other: Stellate Ganglion Block