Transcutaneous Auricular Vagus Nerve Stimulation Treatment on Functional Dyspepsia

• ClinicalTrials.gov Identifier: NCT04706871
• Recruitment Status: Completed
• First Posted: January 13, 2021
• Last Update Posted: January 13, 2021
• Sponsor: Beijing Tongren Hospital
• Information provided by (Responsible Party): Beijing Tongren Hospital

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Functional Dyspepsia	Device: taVNS; Device: tnVNS	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 90 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Transcutaneous Auricular Vagus Nerve Stimulation in the Treatment of Functional Dyspepsia : A Randomized Controlled Trial
• Actual Study Start Date: July 1, 2018
• Actual Primary Completion Date: December 1, 2019
• Actual Study Completion Date: January 1, 2020

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

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

Eligibility Criteria

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

Criteria

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.

Contacts and Locations

Locations

China

Beijing Tongren Hospital

Beijing, China

Sponsors and Collaborators

Beijing Tongren Hospital

More Information

• Responsible Party: Beijing Tongren Hospital
• ClinicalTrials.gov Identifier: NCT04706871
• Other Study ID Numbers: taVNS-FD-2018
• First Posted: January 13, 2021
• Last Update Posted: January 13, 2021
• Last Verified: January 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Beijing Tongren Hospital:

transcutaneous auricular vagus nerve stimulation

Additional relevant MeSH terms:

Dyspepsia; Signs and Symptoms, Digestive