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

Not Applicable

Not yet recruiting

• Conditions: Anxiety Disorders; Stellate Ganglion Block
• Interventions: Other: Stellate Ganglion Block

• Registration Number: NCT06540313
• Lead Sponsor: Nanjing Medical University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-07-09
• Status Verified: 2024-08
• Study First Submitted QC: 2024-08-01
• Last Update Submitted: 2024-08-01
• Study First Posted: 2024-08-06
• Last Update Posted: 2024-08-06
• Study Start: 2024-09-01
• Primary Completion: 2025-07-10
• Study Completion: 2026-06-10

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Relieve anxiety symptoms	Stellate Ganglion Block	-
Restore mental function	Stellate Ganglion Block	-
Verify Stellate Ganglion Block security	Stellate Ganglion Block	-
Explore the Stellate Ganglion Block intervention mechanism	Stellate Ganglion Block	-

Primary Outcome Measures

Name	Time	Method
Insular cortex activity	8 weeks	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.
Hamilton Anxiety Rating Scale	8 weeks	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.
Heart rate variability index	8 weeks	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.
Numeric Rating Scale	8 weeks	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.

Trial Locations

Locations (1)

Nanjing Brain Hospital; 🇨🇳 Nanjing, Jiangsu, China