Transcutaneous Auricular Vagus Nerve Stimulation Treatment on Functional Dyspepsia

NCT ID: NCT04706871

Last Updated: 2021-01-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-01

Study Completion Date

2020-01-01

Brief Summary

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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

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Conditions

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Functional Dyspepsia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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taVNS group

Group Type EXPERIMENTAL

taVNS

Intervention Type 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 group

Group Type PLACEBO_COMPARATOR

tnVNS

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Beijing Tongren Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Beijing Tongren Hospital

Beijing, , China

Site Status

Countries

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China

Other Identifiers

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taVNS-FD-2018

Identifier Type: -

Identifier Source: org_study_id

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