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Transcutaneous Auricular Vagus Nerve Stimulation Treatment on Functional Dyspepsia

Primary Purpose

Functional Dyspepsia

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
taVNS
tnVNS
Sponsored by
Beijing Tongren Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Functional Dyspepsia focused on measuring transcutaneous auricular vagus nerve stimulation

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Beijing Tongren Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

taVNS group

tnVNS group

Arm Description

Outcomes

Primary Outcome Measures

Mean change from Baseline in the FD Symptoms Index at 16 Weeks
FD Symptoms Index to measure the subjective symptoms of dyspepsia.
Mean change from Baseline in the FDQOL at 16 Weeks
FDQOL to measure the subjective quality of life.

Secondary Outcome Measures

Mean change from Baseline in the HAMA at 16 Weeks
HAMA to measure the subjective anxiety symptoms
Mean change from Baseline in the HAMD at 16 Weeks
HAMD to measure the subjective depression symptoms
Mean change from Baseline in the SDS at 16 Weeks
SDS to measure the subjective depression symptoms

Full Information

First Posted
January 11, 2021
Last Updated
January 11, 2021
Sponsor
Beijing Tongren Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04706871
Brief Title
Transcutaneous Auricular Vagus Nerve Stimulation Treatment on Functional Dyspepsia
Official Title
Transcutaneous Auricular Vagus Nerve Stimulation in the Treatment of Functional Dyspepsia : A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
July 1, 2018 (Actual)
Primary Completion Date
December 1, 2019 (Actual)
Study Completion Date
January 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Beijing Tongren Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Functional Dyspepsia
Keywords
transcutaneous auricular vagus nerve stimulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
taVNS group
Arm Type
Experimental
Arm Title
tnVNS group
Arm Type
Placebo Comparator
Intervention Type
Device
Intervention Name(s)
taVNS
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
tnVNS
Intervention Description
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 Outcome Measure Information:
Title
Mean change from Baseline in the FD Symptoms Index at 16 Weeks
Description
FD Symptoms Index to measure the subjective symptoms of dyspepsia.
Time Frame
Day 0, 4-weeks, postintervention at Week 4, postintervention at Week 12
Title
Mean change from Baseline in the FDQOL at 16 Weeks
Description
FDQOL to measure the subjective quality of life.
Time Frame
Day 0, 4-weeks, postintervention at Week 4, postintervention at Week 12
Secondary Outcome Measure Information:
Title
Mean change from Baseline in the HAMA at 16 Weeks
Description
HAMA to measure the subjective anxiety symptoms
Time Frame
Day 0, 4-weeks, postintervention at Week 4, postintervention at Week 12
Title
Mean change from Baseline in the HAMD at 16 Weeks
Description
HAMD to measure the subjective depression symptoms
Time Frame
Day 0, 4-weeks, postintervention at Week 4, postintervention at Week 12
Title
Mean change from Baseline in the SDS at 16 Weeks
Description
SDS to measure the subjective depression symptoms
Time Frame
Day 0, 4-weeks, postintervention at Week 4, postintervention at Week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Beijing Tongren Hospital
City
Beijing
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

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Transcutaneous Auricular Vagus Nerve Stimulation Treatment on Functional Dyspepsia

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