Status:
ENROLLING_BY_INVITATION
Treatment of SSD With tcVNS and taVNS
Lead Sponsor:
National Taiwan University Hospital
Collaborating Sponsors:
Industrial Technology Research Institute, Taiwan
Conditions:
Somatic Symptom Disorder
Anxiety
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief 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 pati...
Detailed Description
Official Title: Treatment of Somatic Symptom Disorder with Transcutaneous Cervical Vagus Nerve Stimulation and Transcutaneous Auricular Vagus Nerve Stimulation: A Crossover Randomized Controlled Trial...
Eligibility Criteria
Inclusion
- 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.
- The participant must be receiving stable, routine medical care throughout the trial period.
- No adjustments to psychiatric or cardiovascular medications for at least one week prior to the start of the study.
Exclusion
- Age below 18 or above 65 years.
- Presence of psychotic symptoms, such as in comorbid schizophrenia.
- Significant cognitive impairment (e.g., diagnosed dementia or intellectual disability) or difficulty completing the study questionnaires.
- History of cervical vagotomy.
- 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.
- Presence of severe neurological conditions, including severe head trauma, history of epilepsy, brain tumor, or cerebral hemorrhage.
- Current diagnosis of cancer.
- 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).
- Anatomical abnormalities in the neck.
- Currently pregnant.
- Wearing jewelry near the tragus that cannot be removed before using the tVNS device.
- Severe skin disease at the stimulation sites.
- Known allergy to conductive gel materials.
- Any other major medical condition that, in the investigator's judgment, could potentially affect the safety or efficacy of vagus nerve stimulation.
Key Trial Info
Start Date :
November 17 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2028
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT07198542
Start Date
November 17 2025
End Date
December 31 2028
Last Update
December 12 2025
Active Locations (1)
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1
Department of Psychiatry, National Taiwan University Hospital Yunlin Branch
Douliu, Yunlin, Taiwan, 640