Efficacy, Safety and Neural Mechanism of Stellate Ganglion Block in the Treatment of Anxiety. Disorder.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Stellate Ganglion Block.
- Who it may be relevant to
- Registry conditions: Anxiety Disorders, Stellate Ganglion Block. Basic parameters: 18 years — 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Efficacy, Safety and Neural Mechanism of Stellate Ganglion Block in the Treatment of Anxiety.
Overview
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.
Interventions
- Other Stellate Ganglion Block
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
Primary outcome measures
- Heart rate variability index [Time frame: 8 weeks]
- Insular cortex activity [Time frame: 8 weeks]
- Numeric Rating Scale [Time frame: 8 weeks]
- Hamilton Anxiety Rating Scale [Time frame: 8 weeks]
Eligibility criteria
Inclusion criteria
- Aged 18-60 years old
- Diagnosed with various types of anxiety disorders according to the DSM-5, and meet the diagnostic criteria for pain disorders
- Right-handed
- Voluntarily join the study and sign the informed consent.
Exclusion criteria
- Suicidal thoughts and behaviors
- serious physical disease
- diseases of the nervous system or other mental diseases
- Contraindications for MRI examination
- During pregnancy or lactation
- Allergy to narcotic drugs
- Contraindications with stellate ganglion block
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Factorial
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Nanjing Brain Hospital — Nanjing
Identifiers
NCT: NCT06540313 · SGB-KY-2024