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Not yet recruitingNCT06540313Updated Aug 6, 2024

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

An interventional study of Stellate Ganglion Block in Anxiety Disorders and Stellate Ganglion Block, sponsored by Nanjing Medical University. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-08-06.

Sponsored by Nanjing Medical University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Jul 2025, 1 year 2 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Anxiety Disorders
  • Stellate Ganglion Block
03

In context

Ganglion Cysts

136 studies on the registry are indexed under Ganglion Cysts; 28 are open to participants now.

This study's planned enrollment of 60 is close to the median of 60 across 101 interventional studies indexed under Ganglion Cysts.

Browse Ganglion Cysts studies →

Lead sponsor

Nanjing Medical University is the lead sponsor of 169 studies on the registry; 51 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Factorial assignment
Masking
None (open label)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    Relieve anxiety symptoms

    Other: Stellate Ganglion Block

  • Experimental
    Restore mental function

    Other: Stellate Ganglion Block

  • Experimental
    Verify Stellate Ganglion Block security

    Other: Stellate Ganglion Block

  • Experimental
    Explore the Stellate Ganglion Block intervention mechanism

    Other: Stellate Ganglion Block

Interventions

  • OtherStellate 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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 8 weeks

  2. 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.

    Time frame: 8 weeks

  3. 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.

    Time frame: 8 weeks

  4. 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.

    Time frame: 8 weeks

07

Study locations

1 site
  • Nanjing Brain Hospital
    Nanjing, Jiangsu 210029, China
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 6, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06540313
Lead sponsor
Nanjing Medical University
Responsible party
Chun Wang (associate professor, Nanjing Medical University) — Principal investigator
First posted
Aug 6, 2024
Start date
Sep 1, 2024 (estimated)
Primary completion
Jul 10, 2025 (estimated)
Completion
Jun 10, 2026 (estimated)
Last update
Aug 6, 2024

Study contacts

Chun Wang
Contact
fm51109@163.com
+8615651728879

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.

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