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ENROLLING BY INVITATION

NCT07198542

Treatment of SSD With tcVNS and taVNS

Sponsor: National Taiwan University Hospital

View on ClinicalTrials.gov

Summary

This study aims to compare two non-invasive nerve stimulation devices, gammaCore and Nurosym, to find out which one is more effective in reducing physical discomfort and health-related anxiety in patients with Somatic Symptom Disorder, a condition where individuals experience significant physical symptoms and have excessive thoughts and worries about their health. Participants in this study will receive treatment using both devices at different times. Both devices work by sending mild electrical pulses through the skin to stimulate the vagus nerve, a major nerve that helps regulate body functions. One device (gammaCore) is placed on the neck, while the other (Nurosym) is worn on the ear. The order in which a participant receives the two treatments will be decided by chance, like flipping a coin. Each treatment period will last for two weeks, with a one-week break in between. Over the course of the study (about 8 weeks), participants will visit the hospital for treatment sessions and to complete questionnaires and have non-invasive measurements of body responses, such as heart rate variability.

Official title: Treatment of Somatic Symptom Disorder With Transcutaneous Cervical Vagus Nerve Stimulation and Transcutaneous Auricular Vagus Nerve Stimulation: A Crossover Randomized Controlled Trial

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2025-11-17

Completion Date

2028-12-31

Last Updated

2025-12-12

Healthy Volunteers

Conditions

Somatic Symptom Disorder Anxiety Depression Transcutaneous Vagus Nerve Stimulation Neuromodulation

Interventions

DEVICE

gammaCore Sapphire

This intervention utilizes transcutaneous cervical Vagus Nerve Stimulation (tcVNS). A conductive gel is applied to the device's stimulation surfaces. The device is then placed on the neck over the vagus nerve. The daily treatment protocol consists of three consecutive 2-minute stimulations on the left side of the neck, with a 30-60 second interval between each stimulation. After a brief rest of approximately one minute, the same procedure is repeated on the right side of the neck. The total daily session duration is approximately 20 minutes. Stimulation intensity is individually titrated for each participant to a level that is perceptible but not painful. This regimen is administered once daily for 10 sessions over a 2-week period.

DEVICE

Nurosym

This intervention utilizes transcutaneous auricular Vagus Nerve Stimulation (taVNS). The device consists of an earpiece electrode that is clipped onto the left tragus. A small amount of water is applied to the skin for conductivity. The daily treatment protocol consists of one continuous 30-minute stimulation session. Stimulation intensity is individually titrated for each participant to a level that is perceptible but not painful. This regimen is administered once daily for 10 sessions over a 2-week period.

Inclusion Criteria: 1. Meets the diagnostic criteria for Somatic Symptom Disorder (SSD) according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), as determined by a diagnostic interview with a board-certified psychiatrist. 2. The participant must be receiving stable, routine medical care throughout the trial period. 3. No adjustments to psychiatric or cardiovascular medications for at least one week prior to the start of the study. Exclusion Criteria: 1. Age below 18 or above 65 years. 2. Presence of psychotic symptoms, such as in comorbid schizophrenia. 3. Significant cognitive impairment (e.g., diagnosed dementia or intellectual disability) or difficulty completing the study questionnaires. 4. History of cervical vagotomy. 5. Presence of severe cardiovascular diseases, including: clinically significant tachycardia (resting heart rate \>100 bpm) or bradycardia (resting heart rate \<60 bpm); clinically significant hypertension (systolic \>160 mmHg or diastolic \>100 mmHg) or hypotension (blood pressure \<90/60 mmHg or mean arterial pressure \<65 mmHg); severe coronary artery disease; carotid atherosclerosis or stenosis; aneurysm; congestive heart failure; severe cardiac arrhythmias (e.g., prolonged QT interval, second- or third-degree atrioventricular block, atrial fibrillation, atrial flutter, recent ventricular tachycardia or fibrillation, clinically significant premature ventricular contractions); or myocardial infarction within the last five years. 6. Presence of severe neurological conditions, including severe head trauma, history of epilepsy, brain tumor, or cerebral hemorrhage. 7. Current diagnosis of cancer. 8. Presence of any active implanted medical devices (e.g., cochlear implant, ventricular shunt, implantable vagus nerve stimulator, pacemaker) or non-active implants that may interact with the nervous system (e.g., metal stents, bone plates, screws). 9. Anatomical abnormalities in the neck. 10. Currently pregnant. 11. Wearing jewelry near the tragus that cannot be removed before using the tVNS device. 12. Severe skin disease at the stimulation sites. 13. Known allergy to conductive gel materials. 14. Any other major medical condition that, in the investigator's judgment, could potentially affect the safety or efficacy of vagus nerve stimulation.

Locations (1)

Department of Psychiatry, National Taiwan University Hospital Yunlin Branch

Douliu, Yunlin, Taiwan