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

NCT ID: NCT06540313

Last Updated: 2024-08-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-01

Study Completion Date

2026-06-10

Brief Summary

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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

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Conditions

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Anxiety Disorders Stellate Ganglion Block

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Relieve anxiety symptoms

Group Type EXPERIMENTAL

Stellate Ganglion Block

Intervention Type 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.

Restore mental function

Group Type EXPERIMENTAL

Stellate Ganglion Block

Intervention Type 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.

Verify Stellate Ganglion Block security

Group Type EXPERIMENTAL

Stellate Ganglion Block

Intervention Type 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

Group Type EXPERIMENTAL

Stellate Ganglion Block

Intervention Type 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.

Interventions

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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 treat a variety of pain and non-pain diseases.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Nanjing Medical University

OTHER

Sponsor Role lead

Responsible Party

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Chun Wang

associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Nanjing Brain Hospital

Nanjing, Jiangsu, China

Site Status

Countries

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China

Central Contacts

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Chun Wang

Role: CONTACT

+8615651728879

Other Identifiers

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SGB-KY-2024

Identifier Type: -

Identifier Source: org_study_id

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