Efficacy, Safety and Neural Mechanism of Stellate Ganglion Block in the Treatment of Anxiety. Disorder.
NCT Number: NCT06540313
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Anxiety Disorders|Stellate Ganglion Block
Interventions: OTHER: Stellate Ganglion Block
Sponsor: Nanjing Medical University
Sex: ALL
Age: ADULT
Enrollment: 60
Study Design: Allocation: RANDOMIZED|Intervention Model: FACTORIAL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09-01
Completion Date: 2026-06-10
Locations: Nanjing Brain Hospital, Nanjing, Jiangsu, 210029, China

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.

Primary Outcome Measures: Heart rate variability index, Heart rate variability is an important index to measure the tone and balance of the sympathetic and parasympathetic nerves. Heart rate variability can reflect the sympathomympathetic nerve function of patients with anxiety disorder., 8 weeks|Insular cortex activity, The insular cortex is the most important cortical region that controls sympathetic and parasympathetic mediated cardiovascular regulation and plays a key role in maintaining body homeostasis. However, a recent study found that the change of heart rate in mice can affect anxiety symptoms through the insular cortex, so it is speculated that SGB may induce the change of insular cortex activity by regulating the activity of sympathetic nervous system, thus alleviating anxiety symptoms., 8 weeks|Numeric Rating Scale, In this study, Numeric Rating Scale was used to explore the efficacy of stellate ganglion block in the treatment of anxiety disorders. The scale consists of 11 numbers from 0 to 10. Patients use 11 numbers, from 0 to 10, to describe the intensity of the pain, and the higher the number, the worse the pain. 0 means no pain, 1 to 3 means mild pain (pain does not affect sleep), 4 to 6 means moderate pain, 7 to 9 means severe pain (can not fall asleep or wake up in sleep), and 10 means severe pain., 8 weeks|Hamilton Anxiety Rating Scale, In this study, Hamilton Anxiety Rating Scale was used to explore the efficacy of stellate ganglion block in the treatment of anxiety disorders.There are 14 items in the scale, and all items are scored with a 5-level scoring method ranging from 0 to 4 points. The sum of the scores of each item is the total score of the scale. A total score of \<7 indicates no anxiety symptoms, a score of 7-13 indicates possible anxiety symptoms, a score of 14-20 indicates certain anxiety symptoms, a score of 21-28 indicates obvious anxiety symptoms, and a score of ≥29 indicates possible severe anxiety symptoms., 8 weeks