Transcutaneous Auricular Vagus Nerve Stimulation Treatment on Functional Dyspepsia

Not Applicable

Completed

• Conditions: Functional Dyspepsia
• Interventions: Device: taVNS; Device: tnVNS

• Registration Number: NCT04706871
• Lead Sponsor: Beijing Tongren Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-07-01
• Primary Completion: 2019-12-01
• Study Completion: 2020-01-01
• Status Verified: 2021-01
• Study First Submitted: 2021-01-11
• Study First Submitted QC: 2021-01-11
• Last Update Submitted: 2021-01-11
• Study First Posted: 2021-01-13
• Last Update Posted: 2021-01-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
taVNS group	taVNS	-
tnVNS group	tnVNS	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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 HAMA at 16 Weeks	Day 0, 4-weeks, postintervention at Week 4, postintervention at Week 12	HAMA to measure the subjective anxiety symptoms

Trial Locations

Locations (1)

Beijing Tongren Hospital; 🇨🇳 Beijing, China