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

NCT06540313 | Not Yet Recruiting

• 1 other identifier: SGB-KY-2024
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

1. 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. 2.Verify the following hypothesis:

Conditions

Anxiety Disorders; Stellate Ganglion Block

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (4)

Relieve anxiety symptoms

EXPERIMENTAL

Other: Stellate Ganglion Block

Restore mental function

EXPERIMENTAL

Other: Stellate Ganglion Block

Verify Stellate Ganglion Block security

EXPERIMENTAL

Other: Stellate Ganglion Block

Explore the Stellate Ganglion Block intervention mechanism

EXPERIMENTAL

Other: Stellate Ganglion Block

Interventions

Stellate Ganglion Block OTHER

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.

Explore the Stellate Ganglion Block intervention mechanism; Relieve anxiety symptoms; Restore mental function; Verify Stellate Ganglion Block security

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Nanjing Medical University: lead

Study Sites (1)

Nanjing Brain Hospital

Nanjing, Jiangsu, 210029, China

Location

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Central Study Contacts

Chun Wang

CONTACT

+8615651728879; fm51109@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate professor

Study Record Dates

• First Submitted: July 9, 2024
• First Posted: August 6, 2024
• Study Start: September 1, 2024
• Primary Completion: July 10, 2025
• Study Completion (Estimated): June 10, 2026
• Last Updated: August 6, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)