Somatic Symptom DisorderNCT07198542
Treatment of SSD With tcVNS and taVNS
A study testing gammaCore Sapphire and Nurosym in people with Somatic Symptom Disorder and Anxiety, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Somatic Symptom Disorder, Anxiety, Depression
- What is being tested?
- gammaCore Sapphire and Nurosym
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- 17 Nov 2025to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site
Department of Psychiatry, National Taiwan University Hospital Yunlin Branch
Douliu, Yunlin, 640
About this study
Official title: Treatment of Somatic Symptom Disorder With Transcutaneous Cervical Vagus Nerve Stimulation and Transcutaneous Auricular Vagus Nerve Stimulation: A Crossover Randomized Controlled Trial
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.
Read the 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.
Study Design: This is a single-center, randomized, single-blind (assessor- and analyst-blinded), crossover clinical trial designed to compare the efficacy of two transcutaneous vagus nerve stimulation (tVNS) devices in patients with Somatic Symptom Disorder (SSD). Participants will be randomly assigned to one of two sequences: (A) Nurosym followed by gammaCore, or (B) gammaCore followed by Nurosym. Each intervention phase consists of 10 daily stimulation sessions administered over a 2-week period (Monday-Friday), followed by a 1-week follow-up assessment. A 1-week washout period will separate the two intervention phases.
Primary Objectives: The primary objective is to compare the efficacy of transcutaneous cervical VNS (tcVNS) delivered by the gammaCore device versus transcutaneous auricular VNS (taVNS) delivered by the Nurosym device on the core symptoms of SSD. This will be measured by the change in scores on the Patient Health Questionnaire-15 (PHQ-15) for somatic symptom severity and the Health Anxiety Questionnaire (HAQ) for health anxiety.
Secondary Objectives: Secondary objectives include evaluating the effects of both treatments on depression, anxiety, worry, and physiological markers of autonomic nervous system function (e.g., heart rate variability, skin conductance, finger temperature). The study will also explore factors that may predict treatment response.
Interventions:
Device 1 (gammaCore): Delivers tcVNS. The device will be applied to the neck over the vagus nerve. The daily session involves three 2-minute stimulations on the left side of the neck, followed by three 2-minute stimulations on the right side, for a total daily treatment time of approximately 20 minutes.
Device 2 (Nurosym): Delivers taVNS. The device uses an earpiece placed on the left tragus to stimulate the auricular branch of the vagus nerve. The daily treatment consists of one continuous 30-minute session.
Stimulation intensity for both devices will be individually titrated for each participant to a level described as a "clear but not uncomfortable or painful sensation".
Outcome Measures:
Primary Endpoints: The primary endpoints are the change from baseline (Day 1 or Day 29) to the 1-week follow-up assessment (Day 19 or Day 47) in PHQ-15 and HAQ scores for each treatment period .
Secondary Endpoints: Secondary outcome measures include the change from baseline to all subsequent assessment points (e.g., Day 5, Day 12, Day 19) in the Beck Depression Inventory-II (BDI-II), Beck Anxiety Inventory (BAI), Penn State Worry Questionnaire (PSWQ), and various physiological parameters. Safety will be assessed by monitoring adverse events throughout the study.
- Conditions
- Somatic Symptom Disorder, Anxiety, Depression, Transcutaneous Vagus Nerve Stimulation, Neuromodulation
- Being tested
- gammaCore Sapphire, Nurosym
- Keywords
- Somatic Symptom Disorder, Transcutaneous Vagus Nerve Stimulation, Neuromodulation, Anxiety, Depression
- Medical subject headings
- Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gammaCore SapphireDevice
Also called Transcutaneous cervical Vagus Nerve Stimulation, tcVNS
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.
NurosymDevice
Also called Transcutaneous auricular Vagus Nerve Stimulation, taVNS
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.
| Study group | Role | What they receive |
|---|---|---|
| Group A: gammaCore then Nurosym | Experimental | Participants assigned to this sequence will first receive active transcutaneous cervical vagus nerve stimulation (tcVNS) using the gammaCore device. This initial treatment period consists of 10 daily sessions (approx. 20 minutes each) over 2 weeks, followed by a 1-week follow-up assessment. After a 1-week washout period, participants will cross over to the second treatment period. In this period, they will receive active transcutaneous auricular vagus nerve stimulation (taVNS) using the Nurosym device for 10 daily 30-minute sessions over 2 weeks, followed by a final 1-week follow-up assessment. Receives: Device: gammaCore Sapphire; Device: Nurosym |
| Group B: Nurosym then gammaCore | Experimental | Participants assigned to this sequence will first receive active transcutaneous auricular vagus nerve stimulation (taVNS) using the Nurosym device. This initial treatment period consists of 10 daily 30-minute sessions over 2 weeks, followed by a 1-week follow-up assessment. After a 1-week washout period, participants will cross over to the second treatment period. In this period, they will receive active transcutaneous cervical vagus nerve stimulation (tcVNS) using the gammaCore device for 10 daily sessions (approx. 20 minutes each) over 2 weeks, followed by a final 1-week follow-up assessment. Receives: Device: gammaCore Sapphire; Device: Nurosym |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Somatic Symptom Severity as Measured by the Patient Health Questionnaire-15 (PHQ-15)
The PHQ-15 is a 15-item self-report scale that assesses the severity of somatic symptoms. Each item is scored from 0 ("not bothered at all") to 2 ("bothered a lot"), resulting in a total score ranging from 0 to 30. Higher scores indicate greater somatic symptom severity. The outcome is the change in the total score from the baseline of each treatment period.
Measured: 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).
Change in Health Anxiety as Measured by the Health Anxiety Questionnaire (HAQ)
The Health Anxiety Questionnaire (HAQ) is a self-report scale used to measure the severity of health-related anxiety, including worries and beliefs about health. Total scores are calculated, with higher scores indicating a greater level of health anxiety. The outcome is the change in the total score from the baseline of each treatment period.
Measured: 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).
Secondary outcomes (7)
Change in Depressive Symptom Severity as Measured by the Beck Depression Inventory-II (BDI-II)
The BDI-II is a 21-item self-report inventory measuring the severity of depression. The total score ranges from 0 to 63, with higher scores indicating more severe depressive symptoms. The outcome is the change in the total score from the baseline of each treatment period.
Measured: Change from baseline (Day 1 or Day 29) to each subsequent assessment point (Day 5, Day 12, Day 19 for the first period; Day 33, Day 40, Day 47 for the second period).
Change in Anxiety Symptom Severity as Measured by the Beck Anxiety Inventory (BAI)
The BAI is a 21-item self-report inventory measuring the severity of anxiety, particularly focusing on somatic symptoms of anxiety. The total score ranges from 0 to 63, with higher scores indicating more severe anxiety. The outcome is the change in the total score from the baseline of each treatment period.
Measured: Change from baseline (Day 1 or Day 29) to each subsequent assessment point (Day 5, Day 12, Day 19 for the first period; Day 33, Day 40, Day 47 for the second period).
Change in General Worry as Measured by the Penn State Worry Questionnaire (PSWQ)
The PSWQ is a self-report questionnaire designed to assess the trait of worry, focusing on its generality, excessiveness, and uncontrollability. Higher scores indicate a greater tendency to worry. The outcome is the change in the total score from the baseline of each treatment period.
Measured: Change from baseline (Day 1 or Day 29) to each subsequent assessment point (Day 5, Day 12, Day 19 for the first period; Day 33, Day 40, Day 47 for the second period).
Change in Autonomic Nervous System Function as Measured by Heart Rate Variability (HRV)
HRV is a measure of the variation in time between consecutive heartbeats, used to assess cardiac autonomic regulation. Frequency-domain (e.g., High-Frequency power [HF], Low-Frequency power [LF], LF/HF ratio) and time-domain (e.g., SDNN) parameters will be analyzed.
Measured: Change from baseline (Day 1 or Day 29) to each subsequent assessment point (Day 5, Day 12, Day 19 for the first period; Day 33, Day 40, Day 47 for the second period).
Change in Cardiac Vagal Control as Measured by Respiratory Sinus Arrhythmia (RSA)
Respiratory Sinus Arrhythmia (RSA) is the naturally occurring variation in heart rate during the breathing cycle and is considered a non-invasive index of cardiac vagal tone. It is derived from concurrently measured electrocardiogram (ECG) and respiration signals. Changes from baseline will be assessed to evaluate the intervention's effect on parasympathetic nervous system activity.
Measured: Change from baseline (Day 1 or Day 29) to each subsequent assessment point (Day 5, Day 12, Day 19 for the first period; Day 33, Day 40, Day 47 for the second period).
Change in Sympathetic Arousal as Measured by Skin Conductance
Skin conductance measures fluctuations in the electrical characteristics of the skin, reflecting sympathetic nervous system activity. Changes from baseline will be assessed to evaluate physiological arousal.
Measured: Change from baseline (Day 1 or Day 29) to each subsequent assessment point (Day 5, Day 12, Day 19 for the first period; Day 33, Day 40, Day 47 for the second period).
Change in Peripheral Vasomotor Activity as Measured by Finger Temperature
Peripheral skin temperature, measured at the finger, is an indicator of peripheral blood flow and is influenced by sympathetic nervous system activity. A decrease in temperature can indicate vasoconstriction associated with stress or arousal. The change from baseline will be assessed.
Measured: Change from baseline (Day 1 or Day 29) to each subsequent assessment point (Day 5, Day 12, Day 19 for the first period; Day 33, Day 40, Day 47 for the second period).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2025
- Study start17 Nov 2025
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Somatic Symptom DisorderStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Industrial Technology Research Institute, Taiwan
- Responsible party
- Sponsor
- Investigators
- Chia-Hao Ma, MD, Principal investigator, Department of Psychiatry, National Taiwan University Hospital Yunlin Branch
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07198542
- Sponsor's protocol ID
- 202411116DIND
- Status last verified
- Dec 2025
- First submitted
- 21 Sep 2025
- Last updated
- 12 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Somatic Symptom Disorder With Transcutaneous Cervical Vagus Nerve Stimulation and Transcutaneous Auricular Vagus Nerve Stimulation: A Crossover Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07198542
- Acronym / sponsor ID
- 202411116DIND
- Conditions
- Somatic Symptom Disorder, Anxiety, Depression, Transcutaneous Vagus Nerve Stimulation, Neuromodulation
- Keywords
- Somatic Symptom Disorder, Transcutaneous Vagus Nerve Stimulation, Neuromodulation, Anxiety, Depression
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Collaborators
- Industrial Technology Research Institute, Taiwan
- Study start
- 17 Nov 2025 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 30 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study Design: This is a single-center, randomized, single-blind (assessor- and analyst-blinded), crossover clinical trial designed to compare the efficacy of two transcutaneous vagus nerve stimulation (tVNS) devices in patients with Somatic Symptom Disorder (SSD). Participants will be randomly assigned to one of two sequences: (A) Nurosym followed by gammaCore, or (B) gammaCore followed by Nurosym. Each intervention phase consists of 10 daily stimulation sessions administered over a 2-week period (Monday-Friday), followed by a 1-week follow-up assessment. A 1-week washout period will separate the two intervention phases.
Primary Objectives: The primary objective is to compare the efficacy of transcutaneous cervical VNS (tcVNS) delivered by the gammaCore device versus transcutaneous auricular VNS (taVNS) delivered by the Nurosym device on the core symptoms of SSD. This will be measured by the change in scores on the Patient Health Questionnaire-15 (PHQ-15) for somatic symptom severity and the Health Anxiety Questionnaire (HAQ) for health anxiety.
Secondary Objectives: Secondary objectives include evaluating the effects of both treatments on depression, anxiety, worry, and physiological markers of autonomic nervous system function (e.g., heart rate variability, skin conductance, finger temperature). The study will also explore factors that may predict treatment response.
Interventions:
Device 1 (gammaCore): Delivers tcVNS. The device will be applied to the neck over the vagus nerve. The daily session involves three 2-minute stimulations on the left side of the neck, followed by three 2-minute stimulations on the right side, for a total daily treatment time of approximately 20 minutes.
Device 2 (Nurosym): Delivers taVNS. The device uses an earpiece placed on the left tragus to stimulate the auricular branch of the vagus nerve. The daily treatment consists of one continuous 30-minute session.
Stimulation intensity for both devices will be individually titrated for each participant to a level described as a "clear but not uncomfortable or painful sensation".
Outcome Measures:
Primary Endpoints: The primary endpoints are the change from baseline (Day 1 or Day 29) to the 1-week follow-up assessment (Day 19 or Day 47) in PHQ-15 and HAQ scores for each treatment period .
Secondary Endpoints: Secondary outcome measures include the change from baseline to all subsequent assessment points (e.g., Day 5, Day 12, Day 19) in the Beck Depression Inventory-II (BDI-II), Beck Anxiety Inventory (BAI), Penn State Worry Questionnaire (PSWQ), and various physiological parameters. Safety will be assessed by monitoring adverse events throughout the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A: gammaCore then Nurosym | Experimental | Device: gammaCore Sapphire, Device: NurosymParticipants assigned to this sequence will first receive active transcutaneous cervical vagus nerve stimulation (tcVNS) using the gammaCore device. This initial treatment period consists of 10 daily sessions (approx. 20 minutes each) over 2 weeks, followed by a 1-week follow-up assessment. After a 1-week washout period, participants will cross over to the second treatment period. In this period, they will receive active transcutaneous auricular vagus nerve stimulation (taVNS) using the Nurosym device for 10 daily 30-minute sessions over 2 weeks, followed by a final 1-week follow-up assessment. |
| Group B: Nurosym then gammaCore | Experimental | Device: gammaCore Sapphire, Device: NurosymParticipants assigned to this sequence will first receive active transcutaneous auricular vagus nerve stimulation (taVNS) using the Nurosym device. This initial treatment period consists of 10 daily 30-minute sessions over 2 weeks, followed by a 1-week follow-up assessment. After a 1-week washout period, participants will cross over to the second treatment period. In this period, they will receive active transcutaneous cervical vagus nerve stimulation (tcVNS) using the gammaCore device for 10 daily sessions (approx. 20 minutes each) over 2 weeks, followed by a final 1-week follow-up assessment. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| gammaCore SapphireAlso: Transcutaneous cervical Vagus Nerve Stimulation, tcVNSThis 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 | Group A: gammaCore then Nurosym, Group B: Nurosym then gammaCore |
| NurosymAlso: Transcutaneous auricular Vagus Nerve Stimulation, taVNSThis 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. | Device | Group A: gammaCore then Nurosym, Group B: Nurosym then gammaCore |
Primary outcome
Change in Somatic Symptom Severity as Measured by the Patient Health Questionnaire-15 (PHQ-15)
Time frame: 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).
The PHQ-15 is a 15-item self-report scale that assesses the severity of somatic symptoms. Each item is scored from 0 ("not bothered at all") to 2 ("bothered a lot"), resulting in a total score ranging from 0 to 30. Higher scores indicate greater somatic symptom severity. The outcome is the change in the total score from the baseline of each treatment period.
Change in Health Anxiety as Measured by the Health Anxiety Questionnaire (HAQ)
Time frame: 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).
The Health Anxiety Questionnaire (HAQ) is a self-report scale used to measure the severity of health-related anxiety, including worries and beliefs about health. Total scores are calculated, with higher scores indicating a greater level of health anxiety. The outcome is the change in the total score from the baseline of each treatment period.
7 secondary outcomes
Change in Depressive Symptom Severity as Measured by the Beck Depression Inventory-II (BDI-II)
Time frame: Change from baseline (Day 1 or Day 29) to each subsequent assessment point (Day 5, Day 12, Day 19 for the first period; Day 33, Day 40, Day 47 for the second period).
Change in Anxiety Symptom Severity as Measured by the Beck Anxiety Inventory (BAI)
Time frame: Change from baseline (Day 1 or Day 29) to each subsequent assessment point (Day 5, Day 12, Day 19 for the first period; Day 33, Day 40, Day 47 for the second period).
Change in General Worry as Measured by the Penn State Worry Questionnaire (PSWQ)
Time frame: Change from baseline (Day 1 or Day 29) to each subsequent assessment point (Day 5, Day 12, Day 19 for the first period; Day 33, Day 40, Day 47 for the second period).
Change in Autonomic Nervous System Function as Measured by Heart Rate Variability (HRV)
Time frame: Change from baseline (Day 1 or Day 29) to each subsequent assessment point (Day 5, Day 12, Day 19 for the first period; Day 33, Day 40, Day 47 for the second period).
Change in Cardiac Vagal Control as Measured by Respiratory Sinus Arrhythmia (RSA)
Time frame: Change from baseline (Day 1 or Day 29) to each subsequent assessment point (Day 5, Day 12, Day 19 for the first period; Day 33, Day 40, Day 47 for the second period).
Change in Sympathetic Arousal as Measured by Skin Conductance
Time frame: Change from baseline (Day 1 or Day 29) to each subsequent assessment point (Day 5, Day 12, Day 19 for the first period; Day 33, Day 40, Day 47 for the second period).
Change in Peripheral Vasomotor Activity as Measured by Finger Temperature
Time frame: Change from baseline (Day 1 or Day 29) to each subsequent assessment point (Day 5, Day 12, Day 19 for the first period; Day 33, Day 40, Day 47 for the second period).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Chia-Hao Ma, MD principal investigator
Department of Psychiatry, National Taiwan University Hospital Yunlin Branch
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing gammaCore Sapphire and Nurosym in people with Somatic Symptom Disorder and Anxiety, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 12 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Somatic Symptom Severity as Measured by the Patient Health Questionnaire-15 (PHQ-15) (time frame: 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).). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2025.