Transcutaneous Auricular Vagus Nerve Stimulation for Meniere Disease

NCT06544590 | Completed

• 1 other identifier: taVNS-MD-2024
• Study Type: observational
• Target: 77
• Locations: 1 country
• Sites: 1

Brief Summary

Objective: To evaluate the effect of Transcutaneous auricular vagus nerve stimulation for the patients Meniere disease. Methods: We enrolled 231 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, 3 months, 6 months, and 12 months. Video head impulse test (VHIT), the caloric test, Tinnitus Handicap Inventory (THI), Dizziness Handicap Inventory (DHI), Pure Tone Audiometry, and visual scale of ear stuffiness to evaluate the therapeutic effects. A difference of P \< 0.05 was considered statistically significant.

Conditions

Meniere Disease

Keywords

Meniere Disease, taVNS, case-control, retrospective

Outcome Measures

Primary Outcomes (1)

• Video head impulse test (VHIT)

  VHIT was used to assess the function of all the six SCCs by measuring the gain of the vestibulo-ocular reflex. The instrument comprises an inertial measurement unit to measure movements of the head and an infrared camera to record eye movements. HIT can calculate the mean gain value (ratio of eye to head velocity) for each of the six SCCs, and also detect covert or overt saccades. During the test, goggles were secured firmly to patients' head to ensure that the goggles did not slip from the face during head movement. Patients sat \~1.5 m in front of a wall on which a visual target was affixed. Before testing, head movement and eye movement were calibrated according to the manufacturer's instructions. According to manufacture recommendations, normal gain values are expected to range between 0.80 and 1.20 for horizontal canals, and 0.70-1.20 for vertical canals. Pathological saccades and gain values below the normal range were recorded.

  Baseline, month 3, 6 and 12

Secondary Outcomes (5)

• The caloric test

  Baseline, month 3, 6 and 12

• Tinnitus Handicap Inventory (THI)

  Baseline, month 3, 6 and 12

• Dizziness Handicap Inventory (DHI)

  Baseline, month 3, 6 and 12

• Pure tone thresholds

  Baseline, month 3, 6 and 12

• Visual analogue scale (VAS)

  Baseline, month 3, 6 and 12

Study Arms (3)

Control group

Drug: Betahistine Mesylate tablet

taVNS group

Device: taVNS; Drug: Betahistine Mesylate tablet

sham taVNS group

Device: taVNS; Drug: Betahistine Mesylate tablet

Interventions

taVNS DEVICE

TaVNS device (Elmmedicare, EC100, Shenzhen, China) was used to apply stimulation for patients. Stimulation parameters comprised an electrical current of 1 mA at a frequency of 20 Hz, with a waveform width of 1 ms \[18,28\]. Repurposed off-the-shelf devices were utilized for this purpose, with the stimulator generating single square-wave pulses lasting 1 ms each. Enhancing conductivity was achieved by wiping the ear with tap water. In the taVNS group received 12 weeks of treatment (30 min each time, once daily, 5 times per week).

sham taVNS group; taVNS group

Betahistine Mesylate tablet DRUG

Betahistine Mesylate tablet (Merislon, Eisai Co., Ltd., China) with the treatment of 6 mg 3 times a day.

Control group; sham taVNS group; taVNS group

Eligibility Criteria

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

Study Population

Meniere Disease is a clinical condition defined by hearing loss, tinnitus, and aural fullness symptoms, there are currently no any medications approved for its treatment. The aim of study is to determine taVNS as an adjunctive therapy could relieve symptoms in treatment period and follow-up period in patients with Meniere disease. Outcome measures include vHIT, the Caloric Test, THI, DHI, Pure Tone Auditory, and VAS.

You may qualify if:

• \. Age \>=18 and Age \<=65. 2. Clinical diagnosis of meniere disease.

You may not qualify if:

• History of depression, tumors, thyroid disease, diabetes, cardiac diseases.
• History of Otorhinolaryngology surgery.
• Pregnant or lactating women.

Sponsors & Collaborators

• Beijing Tongren Hospital: lead

Study Sites (1)

China Beijing TongRen Hospital, Capital Medical University Beijing, China

Beijing, Beijing Municipality, 100730, China

Location

MeSH Terms

Conditions

Meniere Disease

Interventions

Betahistine

Condition Hierarchy (Ancestors)

Endolymphatic Hydrops; Labyrinth Diseases; Ear Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 6, 2024
• First Posted: August 9, 2024
• Study Start: January 1, 2019
• Primary Completion: July 1, 2024
• Study Completion: July 10, 2024
• Last Updated: August 9, 2024

Record last verified: 2024-07

Locations

CN (1)