Transcutaneous Auricular Vagus Nerve Stimulation Treatment on Functional Dyspepsia

NCT04706871 | Completed

• 1 other identifier: taVNS-FD-2018
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Functional Dyspepsia

Keywords

transcutaneous auricular vagus nerve stimulation

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (3)

• Mean change from Baseline in the HAMA at 16 Weeks

  Day 0, 4-weeks, postintervention at Week 4, postintervention at Week 12

• Mean change from Baseline in the HAMD at 16 Weeks

  Day 0, 4-weeks, postintervention at Week 4, postintervention at Week 12

• Mean change from Baseline in the SDS at 16 Weeks

  Day 0, 4-weeks, postintervention at Week 4, postintervention at Week 12

Study Arms (2)

taVNS group

EXPERIMENTAL

Device: taVNS

tnVNS group

PLACEBO COMPARATOR

Device: tnVNS

Interventions

taVNS 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.

taVNS group

tnVNS 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.

tnVNS group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Age \>=18 and Age \<=65. 2. Clinical diagnosis of functional dyspepsia.

You may not qualify if:

• \. History of depression, tumors, thyroid disease, diabetes, cardiac diseases. 2. History of gastrointestinal surgery. 3. Pregnant or lactating women.

Sponsors & Collaborators

• Beijing Tongren Hospital: lead

Study Sites (1)

Beijing Tongren Hospital

Beijing, China

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 11, 2021
• First Posted: January 13, 2021
• Study Start: July 1, 2018
• Primary Completion: December 1, 2019
• Study Completion: January 1, 2020
• Last Updated: January 13, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)