Transcutaneous Auricular Vagus Nerve Stimulation for Meniere Disease: A Retrospective Study
Overview
- Phase
- N/A
- Intervention
- Betahistine Mesylate tablet
- Conditions
- Meniere Disease
- Sponsor
- Beijing Tongren Hospital
- Enrollment
- 77
- Locations
- 1
- Primary Endpoint
- Video head impulse test (VHIT)
- Status
- Completed
- Last Updated
- last year
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Age \>=18 and Age \<=
- •Clinical diagnosis of meniere disease.
Exclusion Criteria
- •History of depression, tumors, thyroid disease, diabetes, cardiac diseases.
- •History of Otorhinolaryngology surgery.
- •Pregnant or lactating women.
Arms & Interventions
Control group
Intervention: Betahistine Mesylate tablet
taVNS group
Intervention: taVNS
taVNS group
Intervention: Betahistine Mesylate tablet
sham taVNS group
Intervention: taVNS
sham taVNS group
Intervention: Betahistine Mesylate tablet
Outcomes
Primary Outcomes
Video head impulse test (VHIT)
Time Frame: Baseline, month 3, 6 and 12
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.
Secondary Outcomes
- Tinnitus Handicap Inventory (THI)(Baseline, month 3, 6 and 12)
- Visual analogue scale (VAS)(Baseline, month 3, 6 and 12)
- Dizziness Handicap Inventory (DHI)(Baseline, month 3, 6 and 12)
- The caloric test(Baseline, month 3, 6 and 12)
- Pure tone thresholds(Baseline, month 3, 6 and 12)