Transcutaneous Auricular Vagus Nerve Stimulation Treatment on Functional Dyspepsia

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

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.

Study Overview

• Status: Completed
• Conditions: Functional Dyspepsia
• Intervention / Treatment: Device: taVNS; Device: tnVNS

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • Beijing Tongren Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: taVNS group	Device: taVNS; 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.
Placebo Comparator: tnVNS group	Device: tnVNS; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Beijing Tongren Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2018
• Primary Completion (Actual): December 1, 2019
• Study Completion (Actual): January 1, 2020

Study Registration Dates

• First Submitted: January 11, 2021
• First Submitted That Met QC Criteria: January 11, 2021
• First Posted (Actual): January 13, 2021

Study Record Updates

• Last Update Posted (Actual): January 13, 2021
• Last Update Submitted That Met QC Criteria: January 11, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: transcutaneous auricular vagus nerve stimulation
• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Dyspepsia
• Other Study ID Numbers: taVNS-FD-2018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No