Transcutaneous Auricular Vagus Nerve Stimulation Treatment on Functional Dyspepsia

Functional Dyspepsia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04706871
• Other study ID #: taVNS-FD-2018
• Status: Completed
• Phase: N/A
• Start date: July 1, 2018
• Est. completion date: January 1, 2020

Study information

• Verified date: January 2021
• Source: Beijing Tongren Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: January 1, 2020
• Est. primary completion date: December 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dyspepsia
• Functional Dyspepsia

Intervention

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.
• 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.

Locations

Country	Name	City	State
China	Beijing Tongren Hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Tongren Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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