Treatment of SSD With tcVNS and taVNS (NCT07198542) | Clinical Trial Compass
By InvitationNot Applicable
Treatment of SSD With tcVNS and taVNS
Taiwan60 participantsStarted 2025-11-17
Plain-language 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.
Who can participate
Age range18 Years – 65 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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 criteria
✕. 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.
What they're measuring
1
Change in Somatic Symptom Severity as Measured by the Patient Health Questionnaire-15 (PHQ-15)
Timeframe: Change from baseline (Day 1 for the first period; Day 29 for the second period) to the 1-week post-treatment follow-up assessment (Day 19 for the first period; Day 47 for the second period).
2
Change in Health Anxiety as Measured by the Health Anxiety Questionnaire (HAQ)
Timeframe: Change from baseline (Day 1 for the first period; Day 29 for the second period) to the 1-week post-treatment follow-up assessment (Day 19 for the first period; Day 47 for the second period).
✕. 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).