Skip to main content
OpenTrials
Completed

NCT Number: NCT04706871

Transcutaneous Auricular Vagus Nerve Stimulation Treatment on Functional Dyspepsia

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Functional Dyspepsia

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beijing Tongren Hospital

Beijing, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

taVNS

Device

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.

tnVNS

Device

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.

Primary outcomes

  1. Mean change from Baseline in the FD Symptoms Index at 16 Weeks

    Time frame: Day 0, 4-weeks, postintervention at Week 4, postintervention at Week 12

    FD Symptoms Index to measure the subjective symptoms of dyspepsia.

  2. Mean change from Baseline in the FDQOL at 16 Weeks

    Time frame: Day 0, 4-weeks, postintervention at Week 4, postintervention at Week 12

    FDQOL to measure the subjective quality of life.

Secondary outcomes

  1. Mean change from Baseline in the HAMA at 16 Weeks

    Time frame: Day 0, 4-weeks, postintervention at Week 4, postintervention at Week 12

    HAMA to measure the subjective anxiety symptoms

  2. Mean change from Baseline in the HAMD at 16 Weeks

    Time frame: Day 0, 4-weeks, postintervention at Week 4, postintervention at Week 12

    HAMD to measure the subjective depression symptoms

  3. Mean change from Baseline in the SDS at 16 Weeks

    Time frame: Day 0, 4-weeks, postintervention at Week 4, postintervention at Week 12

    SDS to measure the subjective depression symptoms

Sponsors and collaborators

Lead sponsor

Beijing Tongren Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
Jan 13, 2021
Registry last updated
Jan 13, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.