Transcutaneous Vagus Nerve Stimulation for Generalized Anxiety Disorder

Generalized Anxiety Disorder Clinical Trial

Official title:

Efficacy and Mechanism of Transcutaneous Vagus Nerve Stimulation in the Treatment of Generalized Anxiety Disorder

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06134323
• Other study ID #: KY20232271-F-1
• Status: Recruiting
• Phase: N/A
• Start date: December 5, 2023
• Est. completion date: September 30, 2025

Study information

• Verified date: November 2023
• Source: Xijing Hospital
• Contact: Yihuan Yihuan
• Phone: 86-18392135076
• Email: chenyihuan12345[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a randomized, double-blind, parallel-controlled study of patients with generalized anxiety disorder, who will be randomly assigned to either drug-combined transcutaneous vagus nerve stimulation (tVNS) group or drug-combined sham-stimulation group for a period of 4 weeks of treatment.Scale assessments will be performed at baseline, week 1, week 2, week 3, and week 4 of treatment, and brain function monitoring as well as laboratory tests will be performed at baseline and at the end of treatment, respectively.The aim of this study is to investigate the efficacy of medication combined with tVNS and the possible mechanisms of tVNS in the treatment of anxiety.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 82
• Est. completion date: September 30, 2025
• Est. primary completion date: August 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Meeting DSM-5 diagnostic criteria for Generalized Anxiety Disorder;
• Having a first episode of Generalized Anxiety Disorder or not having used an anxiolytic, antidepressant, antipsychotic, or anticonvulsant medication in the last 1 month.
• Having a Hamilton Anxiety Scale (HAMA) score of more than 14 and a Hamilton Depression Scale (HAMD-17) score of less than 17.

Exclusion Criteria:

• Having organic brain lesions (e.g., cerebral hemorrhage, massive cerebral infarction, encephalitis, epilepsy); cardiac QTc interval > 450ms;
• Current or previous diagnosis of other major diseases (e.g., coronary heart disease, pulmonary heart disease, etc.)
• Currently or previously diagnosed with a mental disorder other than anxiety disorder (except for insomnia disorder);
• Those who are participating or have participated in vagus nerve stimulation therapy; those who are participating in transcranial magnetic stimulation or transcranial direct current therapy;
• Pregnant, breastfeeding, or planning to become pregnant during the trial;
• Refusing to sign the informed consent form.

Related Conditions & MeSH terms

• Anxiety Disorders
• Generalized Anxiety Disorder

Intervention

Device:
• medication-combined transcutaneous vagus nerve stimulation
Two electrodes will be applied 2 cm below the left carotid sinus for active stimulation
• medication-combined sham stimulation
Two electrodes will be applied 2 cm below the left carotid sinus for sham stimulation

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Air Force Military Medical University	Xi'an	Shaanxi
China	Xi'an No.3 Hospital	Xi'an	Shaanxi

Sponsors (1)

Lead Sponsor	Collaborator
Xijing Hospital

Country where clinical trial is conducted

China, 

References & Publications (6)

Batelaan NM, Bosman RC, Muntingh A, Scholten WD, Huijbregts KM, van Balkom AJLM. Risk of relapse after antidepressant discontinuation in anxiety disorders, obsessive-compulsive disorder, and post-traumatic stress disorder: systematic review and meta-analysis of relapse prevention trials. BMJ. 2017 Sep 13;358:j3927. doi: 10.1136/bmj.j3927. Erratum In: BMJ. 2017 Sep 25;358:j4461. — View Citation

Bereza BG, Machado M, Ravindran AV, Einarson TR. Evidence-based review of clinical outcomes of guideline-recommended pharmacotherapies for generalized anxiety disorder. Can J Psychiatry. 2012 Aug;57(8):470-8. doi: 10.1177/070674371205700805. — View Citation

Bonaz B, Bazin T, Pellissier S. The Vagus Nerve at the Interface of the Microbiota-Gut-Brain Axis. Front Neurosci. 2018 Feb 7;12:49. doi: 10.3389/fnins.2018.00049. eCollection 2018. — View Citation

Huang Y, Wang Y, Wang H, Liu Z, Yu X, Yan J, Yu Y, Kou C, Xu X, Lu J, Wang Z, He S, Xu Y, He Y, Li T, Guo W, Tian H, Xu G, Xu X, Ma Y, Wang L, Wang L, Yan Y, Wang B, Xiao S, Zhou L, Li L, Tan L, Zhang T, Ma C, Li Q, Ding H, Geng H, Jia F, Shi J, Wang S, Zhang N, Du X, Du X, Wu Y. Prevalence of mental disorders in China: a cross-sectional epidemiological study. Lancet Psychiatry. 2019 Mar;6(3):211-224. doi: 10.1016/S2215-0366(18)30511-X. Epub 2019 Feb 18. Erratum In: Lancet Psychiatry. 2019 Apr;6(4):e11. — View Citation

Noble LJ, Meruva VB, Hays SA, Rennaker RL, Kilgard MP, McIntyre CK. Vagus nerve stimulation promotes generalization of conditioned fear extinction and reduces anxiety in rats. Brain Stimul. 2019 Jan-Feb;12(1):9-18. doi: 10.1016/j.brs.2018.09.013. Epub 201 — View Citation

Slee A, Nazareth I, Bondaronek P, Liu Y, Cheng Z, Freemantle N. Pharmacological treatments for generalised anxiety disorder: a systematic review and network meta-analysis. Lancet. 2019 Feb 23;393(10173):768-777. doi: 10.1016/S0140-6736(18)31793-8. Epub 2019 Jan 31. Erratum In: Lancet. 2019 Apr 27;393(10182):1698. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in the Hamilton Anxiety Scale at Baseline and Week 2 of Treatment	The Hamilton Anxiety Scale is a physician evaluation scale commonly used in clinical practice to assess the level of anxiety in patients. Changes in its scores accurately reflect changes in anxiety symptoms. In this study, changes in scores at baseline and the second week of treatment will be used as the primary outcome measure.	Baseline and Week 2 of the treatment
Secondary	Changes in the Hamilton Anxiety Scale at Baseline and Week 4 of Treatment	The Hamilton Anxiety Scale is a physician evaluation scale commonly used in clinical practice to assess the level of anxiety in patients. Changes in its scores accurately reflect changes in anxiety symptoms.Higher scores mean that the patient's anxiety is more severe.	Baseline and Week 4 of the treatment
Secondary	Changes in the Hamilton Depression Scale at Baseline and Week 2 of Treatment	The Hamilton Depression Scale is a physician evaluation scale commonly used in clinical practice to assess the level of depression in patients. Changes in its scores accurately reflect changes in depressive symptoms.Higher scores mean that the patient is more severely depressed.	Baseline and Week 2 of the treatment
Secondary	Changes in the Hamilton Depression Scale at Baseline and Week 4 of Treatment	The Hamilton Depression Scale is a physician evaluation scale commonly used in clinical practice to assess the level of depression in patients. Changes in its scores accurately reflect changes in depressive symptoms.Higher scores mean that the patient is more severely depressed.	Baseline and Week 4 of the treatment
Secondary	Changes in the Generalized Anxiety Scale at Baseline and Week 2 of Treatment	The Generalized Anxiety Scale is a self-assessment scale commonly used in clinical practice to evaluate generalized anxiety symptoms. It has only 7 items and is easy to use.Higher scores mean that the patient's anxiety is more severe.	Baseline and Week 2 of the treatment
Secondary	Changes in the Generalized Anxiety Scale at Baseline and Week 4 of Treatment	The Generalized Anxiety Scale is a self-assessment scale commonly used in clinical practice to evaluate generalized anxiety symptoms. It has only 7 items and is easy to use.Higher scores mean that the patient's anxiety is more severe.	Baseline and Week 4 of the treatment
Secondary	Changes in brain function indicators from baseline to end of treatment	Functional near-infrared spectroscopy and event-related potentials will be used in this study to examine brain function in patients.Event-related potential (ERP) is a special brain evoked potential that is generated by intentionally giving a stimulus a special psychological meaning, using multiple or multiple stimuli. Functional near-infrared spectroscopy (fNIRS) can utilize the good scattering of 600-900nm near-infrared light by the main components of blood to obtain changes in oxyhemoglobin and deoxyhemoglobin during brain activity.	Baseline and Week 4 of the treatment
Secondary	Incidence of adverse events in each group	During the study period, any treatment-related adverse events will be recorded and used to evaluate the safety of the intervention.Common side effects include changes in pronunciation, hoarseness, neck pain, cough, vomiting, etc	Baseline and Week 4 of the treatment