Transcutaneous Auricular Vagus Nerve Stimulation Treatment on Functional Dyspepsia

Study Overview
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Brief Summary
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Objective: To observe the effect of the treatment of transcutaneous auricular vagus nerve stimulation (taVNS) for the functional dyspepsia (FD). Methods: We accrued 94 patients at Beijing TongRen Hospital. All treatments were self-administered by the patients at home after training at the hospital. Patients completed questionnaires at baseline and after 4 weeks, 8 weeks, 12 weeks. The FD Symptoms Index, Functional Dyspepsia Quality of Life Scale (FDDQL), Hamilton Anxiety Scale (HAMA), Hamilton Depression Scale (HAMD), and Self-Depression Rating Scale (SDS) were performed to evaluate the therapeutic effects. A difference of P < 0.05 was considered statistically significant.

Official Title
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Transcutaneous Auricular Vagus Nerve Stimulation in the Treatment of Functional Dyspepsia : A Randomized Controlled Trial

Conditions
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Functional Dyspepsia

Intervention / Treatment
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* Device: taVNS
* Device: tnVNS


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1. Age >=18 and Age <=65. 2. Clinical diagnosis of functional dyspepsia. Exclusion Criteria: 1. History of depression, tumors, thyroid disease, diabetes, cardiac diseases. 2. History of gastrointestinal surgery. 3. Pregnant or lactating women.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: taVNS group<br> | Device: taVNS<br>* taVNS was applied using a Huatuo stimulator (SDZ-IIB) developed by Suzhou manufacture of Medical Device and Material. Stimulation parameters was 1 mA of electrical current at a frequency of 30 Hz with pulse duration ≤ 1 ms, for 30min, administered twice daily. The two electrodes were placed on the cymba conchae and concha around the left ear.<br>|
| Placebo Comparator: tnVNS group<br> | Device: tnVNS<br>* tnVNS was applied using a Huatuo stimulator (SDZ-IIB) developed by Suzhou manufacture of Medical Device and Material. Stimulation parameters was 1 mA of electrical current at a frequency of 30 Hz with pulse duration ≤ 1 ms, for 30min, administered twice daily. The two electrodes were placed on the antihelix around the left ear.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change from Baseline in the FD Symptoms Index at 16 Weeks | FD Symptoms Index to measure the subjective symptoms of dyspepsia. | Day 0, 4-weeks, postintervention at Week 4, postintervention at Week 12 | 
| Mean change from Baseline in the FDQOL at 16 Weeks | FDQOL to measure the subjective quality of life. | Day 0, 4-weeks, postintervention at Week 4, postintervention at Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change from Baseline in the HAMA at 16 Weeks | HAMA to measure the subjective anxiety symptoms | Day 0, 4-weeks, postintervention at Week 4, postintervention at Week 12 | 
| Mean change from Baseline in the HAMD at 16 Weeks | HAMD to measure the subjective depression symptoms | Day 0, 4-weeks, postintervention at Week 4, postintervention at Week 12 | 
| Mean change from Baseline in the SDS at 16 Weeks | SDS to measure the subjective depression symptoms | Day 0, 4-weeks, postintervention at Week 4, postintervention at Week 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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transcutaneous auricular vagus nerve stimulation