Functional Dyspepsia
Conditions
Keywords
transcutaneous auricular vagus nerve stimulation
Brief summary
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.
Interventions
DEVICEtaVNS
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.
DEVICEtnVNS
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.
Sponsors
Beijing Tongren Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean change from Baseline in the FD Symptoms Index at 16 Weeks | Day 0, 4-weeks, postintervention at Week 4, postintervention at Week 12 | FD Symptoms Index to measure the subjective symptoms of dyspepsia. |
| Mean change from Baseline in the FDQOL at 16 Weeks | Day 0, 4-weeks, postintervention at Week 4, postintervention at Week 12 | FDQOL to measure the subjective quality of life. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean change from Baseline in the HAMA at 16 Weeks | Day 0, 4-weeks, postintervention at Week 4, postintervention at Week 12 | HAMA to measure the subjective anxiety symptoms |
| Mean change from Baseline in the HAMD at 16 Weeks | Day 0, 4-weeks, postintervention at Week 4, postintervention at Week 12 | HAMD to measure the subjective depression symptoms |
| Mean change from Baseline in the SDS at 16 Weeks | Day 0, 4-weeks, postintervention at Week 4, postintervention at Week 12 | SDS to measure the subjective depression symptoms |
Countries
China
Outcome results
None listed