Transcutaneous Auricular Vagus Nerve Stimulation Treatment on Functional Dyspepsia

Capital Medical University

Status: Completed

Conditions: Functional Dyspepsia

Treatments: Device: taVNS; Device: tnVNS

Study type: Interventional

Funder types: Other

Identifiers

NCT04706871

taVNS-FD-2018

Details and patient eligibility

About

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.

Enrollment: 90 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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90 participants in 2 patient groups, including a placebo group

taVNS group

Experimental group

Treatment:

Device: taVNS

tnVNS group

Placebo Comparator group

Treatment:

Device: tnVNS