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Transcutaneous Auricular Vagus Nerve Stimulation for Meniere Disease

Primary Purpose

Meniere Disease

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Transcutaneous Auricular Vagus Nerve Stimulation with Betahistine
Sponsored by
Beijing Tongren Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Meniere Disease focused on measuring Meniere Disease, taVNS, RCT

Eligibility Criteria

20 Years - 61 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Age >=18 and Age <=70.
  2. Clinical diagnosis of meniere disease.

Exclusion Criteria:

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

Sites / Locations

  • Beijing TongRen Hospital, Capital Medical University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

taVNS group

Control Group

Arm Description

taVNS was applied using a Huatuo stimulator (SDZIIB) 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. Participants received betahistine mesylate tablet (Merislon, Eisai Co., Ltd., China) with the treatment of 6 mg 3 times a day.

tnVNS was applied using a Huatuo stimulator (SDZIIB) 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. Participants received betahistine mesylate tablet (Merislon, Eisai Co., Ltd., China) with the treatment of 6 mg 3 times a day.

Outcomes

Primary Outcome Measures

Tinnitus Handicap Inventory (THI)
The THI is a 25-items, self-reported questionnaire regarding tinnitus handicap in daily life. The questionnaire comprises a 12-item functional subscale, an 8-item emotional subscale, and a 5-item catastrophic subscale. The three answer options are "yes," "sometimes," and "no," with scores of 4, 2, and 0, respectively. The overall score is the sum of 25 items (Range: 0-100). Higher scores equate to greater severity of tinnitus symptoms. measure the subjective tinnitus symptoms.
Dizziness Handicap Inventory (DHI)
The DHI is 25-items self-reported questionnaire that used to evaluate the functional, emotional, and physical impact of dizziness on patients' daily life. Among the overall 25 items of questions, 9 items are emotional related, 9 items are functional related, and 7 items are physical related questions. The three answer options are "yes," "sometimes," and "no," with scores of 4, 2, and 0, respectively. The overall score is the sum of 25 items (Range: 0-100). Higher scores equate to greater severity of dizziness symptoms.
Pure tone thresholds.
The pure tone thresholds was performed in a sound-attenuated, double-walled booth with circumaural headphones (Sennheiser HD 280 for frequencies from 250 to 8000 Hz and Sennheiser HD 200 for frequencies from 8000 to 14000 Hz; Sennheiser, Old Lyme, USA) on a certified and calibrated audiometric system (Interacoustics, Middelfart, Denmark). Thresholds were measured using a probe-detection paradigm with pure tones presented for 250 ms at frequencies of 250, 500, 1000, 2000, 4000, 8000 Hz for each ear. To determine the LDL, the volume was set to 75 dB at 1000 Hz and then continuously raised in 5 dB steps (every 5 s) until the subject gave the signal that this volume was uncomfortable. When the volume exceeded 110 dB the test was stopped to prevent any hearing damage. The severity of hearing impairment was calculated as mild (20-40 dB), moderate (41-70 dB), severe (71-95 dB) and profound (>95 dB). Normal hearing was defined as pure-tone thresholds less than 20 dB.
Visual analogue scale (VAS)
The VAS scale of aural fullness consists of a 100 mm straight line with defined endpoints ("no aural fullness" and "worst aural fullness imaginable") on which the patients were asked to mark their experienced aural fullness (results in mm) at the actual time ("VAS now"). The higher VAS score (Range: 0-100) is correlated with a severe aural fullness.

Secondary Outcome Measures

The Short Form Health Survey (SF36)
The Short Form Health Survey (SF36) attempts to represent multidimensional health concepts and measurements of the full range of health states, including levels of well-being and personal evaluations of health. SF36 is used widely to assess physical and mental well-being in social and individual contexts. Eight subscales are derived, referring to 8 health concepts: physical functioning (SF36-PF), role functioning-physical (SF36-RP), bodily pain (SF36-BP), general health (SF36-GH), vitality (SF36-VT), social functioning (SF36-SF), role functioning-emotional (SF36-RE), and mental health (SF36-MH). Each subscale ranges from 0 (worst health) to 100 (best health), and a score of 50 represents the mean score for the population.
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. vHIT 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.
The caloric test
The caloric test was employed to evaluate the horizontal semicircular canal (SCC). The patients took supine position and raised their head to 30 degrees with a pillow. The right and left ears of the patients were stimulated with cool air (24°C) and warm air (50°C) by using an air caloric irrigator system (Micromedical Technologies Inc., Chatham, IL, USA) and a Brookler-Grams closed-loop irrigation unit. We used videonystagmography (VNG) (Ulmer Inc. Marseille, France) to record horizontal eye movements during the test. The subjects were perfused four times for 60 s. After perfusion, the nystagmus was observed for 60 s. Unilateral Weakness (UW) was calculated using the maximal slow phase eye velocity: UW = | (RC + RW) - (LC + LW) | / (RC + RW +LC + LW) × 100%, where RC = right cool, RW = right warm, LC = left cool, and LW = left warm. UW >25% was considered abnormal.

Full Information

First Posted
March 15, 2022
Last Updated
October 27, 2022
Sponsor
Beijing Tongren Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05328895
Brief Title
Transcutaneous Auricular Vagus Nerve Stimulation for Meniere Disease
Official Title
Transcutaneous Auricular Vagus Nerve Stimulation for Meniere Disease: Randomized Trial Controlled
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
October 1, 2020 (Actual)
Primary Completion Date
January 1, 2022 (Actual)
Study Completion Date
May 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Beijing Tongren Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Objective: To evaluate the effect of Transcutaneous auricular vagus nerve stimulation for the patients Meniere disease. Methods: We enrolled 88 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. Tinnitus Handicap Inventory (THI), Dizziness Handicap Inventory (DHI), Pure Tone Audiometry, visual scale of ear stuffiness and SF-36 were performed to evaluate the therapeutic effects. A difference of P < 0.05 was considered statistically significant.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Meniere Disease
Keywords
Meniere Disease, taVNS, RCT

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
92 (Actual)

8. Arms, Groups, and Interventions

Arm Title
taVNS group
Arm Type
Experimental
Arm Description
taVNS was applied using a Huatuo stimulator (SDZIIB) 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. Participants received betahistine mesylate tablet (Merislon, Eisai Co., Ltd., China) with the treatment of 6 mg 3 times a day.
Arm Title
Control Group
Arm Type
Placebo Comparator
Arm Description
tnVNS was applied using a Huatuo stimulator (SDZIIB) 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. Participants received betahistine mesylate tablet (Merislon, Eisai Co., Ltd., China) with the treatment of 6 mg 3 times a day.
Intervention Type
Other
Intervention Name(s)
Transcutaneous Auricular Vagus Nerve Stimulation with Betahistine
Intervention Description
Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) on the left ear was selected and stimulated with electronic acupuncture apparatus (Hwato, SDZ-IIB), with continuous wave, 25 Hz in frequency, 4 to 8 mA in intensity depending on patient's tolerance. The first 3 treatments were conducted in hospital, during which, the patients were trained to use the apparatus under the instruction of research staff. Afterwards, the rest treatments were exerted at home, twice a day, after every breakfast and dinner respectively, 30 min each time. The treatment was given from Monday to Friday a week, totally for 12 weeks. Participants received betahistine mesylate tablet (Merislon, Eisai Co., Ltd., China) with the treatment of 6 mg 3 times a day.
Primary Outcome Measure Information:
Title
Tinnitus Handicap Inventory (THI)
Description
The THI is a 25-items, self-reported questionnaire regarding tinnitus handicap in daily life. The questionnaire comprises a 12-item functional subscale, an 8-item emotional subscale, and a 5-item catastrophic subscale. The three answer options are "yes," "sometimes," and "no," with scores of 4, 2, and 0, respectively. The overall score is the sum of 25 items (Range: 0-100). Higher scores equate to greater severity of tinnitus symptoms. measure the subjective tinnitus symptoms.
Time Frame
Change from Baseline scores of THI at 12-weeks post-therapy.
Title
Dizziness Handicap Inventory (DHI)
Description
The DHI is 25-items self-reported questionnaire that used to evaluate the functional, emotional, and physical impact of dizziness on patients' daily life. Among the overall 25 items of questions, 9 items are emotional related, 9 items are functional related, and 7 items are physical related questions. The three answer options are "yes," "sometimes," and "no," with scores of 4, 2, and 0, respectively. The overall score is the sum of 25 items (Range: 0-100). Higher scores equate to greater severity of dizziness symptoms.
Time Frame
Change from Baseline scores of DHI at 12-weeks post-therapy.
Title
Pure tone thresholds.
Description
The pure tone thresholds was performed in a sound-attenuated, double-walled booth with circumaural headphones (Sennheiser HD 280 for frequencies from 250 to 8000 Hz and Sennheiser HD 200 for frequencies from 8000 to 14000 Hz; Sennheiser, Old Lyme, USA) on a certified and calibrated audiometric system (Interacoustics, Middelfart, Denmark). Thresholds were measured using a probe-detection paradigm with pure tones presented for 250 ms at frequencies of 250, 500, 1000, 2000, 4000, 8000 Hz for each ear. To determine the LDL, the volume was set to 75 dB at 1000 Hz and then continuously raised in 5 dB steps (every 5 s) until the subject gave the signal that this volume was uncomfortable. When the volume exceeded 110 dB the test was stopped to prevent any hearing damage. The severity of hearing impairment was calculated as mild (20-40 dB), moderate (41-70 dB), severe (71-95 dB) and profound (>95 dB). Normal hearing was defined as pure-tone thresholds less than 20 dB.
Time Frame
Change from Baseline level of Pure tone thresholds at 12-weeks post-therapy.
Title
Visual analogue scale (VAS)
Description
The VAS scale of aural fullness consists of a 100 mm straight line with defined endpoints ("no aural fullness" and "worst aural fullness imaginable") on which the patients were asked to mark their experienced aural fullness (results in mm) at the actual time ("VAS now"). The higher VAS score (Range: 0-100) is correlated with a severe aural fullness.
Time Frame
Change from Baseline scores of VAS of aural fullness at 12-weeks post-therapy.
Secondary Outcome Measure Information:
Title
The Short Form Health Survey (SF36)
Description
The Short Form Health Survey (SF36) attempts to represent multidimensional health concepts and measurements of the full range of health states, including levels of well-being and personal evaluations of health. SF36 is used widely to assess physical and mental well-being in social and individual contexts. Eight subscales are derived, referring to 8 health concepts: physical functioning (SF36-PF), role functioning-physical (SF36-RP), bodily pain (SF36-BP), general health (SF36-GH), vitality (SF36-VT), social functioning (SF36-SF), role functioning-emotional (SF36-RE), and mental health (SF36-MH). Each subscale ranges from 0 (worst health) to 100 (best health), and a score of 50 represents the mean score for the population.
Time Frame
Change from Baseline scores of SF-36 at 12-weeks post-therapy.
Title
Video head impulse test (vHIT)
Description
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. vHIT 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.
Time Frame
Change from Baseline number of pathological saccades and values of vHIT at 12-weeks post-therapy.
Title
The caloric test
Description
The caloric test was employed to evaluate the horizontal semicircular canal (SCC). The patients took supine position and raised their head to 30 degrees with a pillow. The right and left ears of the patients were stimulated with cool air (24°C) and warm air (50°C) by using an air caloric irrigator system (Micromedical Technologies Inc., Chatham, IL, USA) and a Brookler-Grams closed-loop irrigation unit. We used videonystagmography (VNG) (Ulmer Inc. Marseille, France) to record horizontal eye movements during the test. The subjects were perfused four times for 60 s. After perfusion, the nystagmus was observed for 60 s. Unilateral Weakness (UW) was calculated using the maximal slow phase eye velocity: UW = | (RC + RW) - (LC + LW) | / (RC + RW +LC + LW) × 100%, where RC = right cool, RW = right warm, LC = left cool, and LW = left warm. UW >25% was considered abnormal.
Time Frame
Change from Baseline number of abnormal Unilateral Weakness (UW) at 12-weeks post-therapy.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
61 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age >=18 and Age <=70. Clinical diagnosis of meniere disease. Exclusion Criteria: History of depression, tumors, thyroid disease, diabetes, cardiac diseases. History of Otorhinolaryngology surgery. Pregnant or lactating women.
Facility Information:
Facility Name
Beijing TongRen Hospital, Capital Medical University
City
Beijing
Country
China

12. IPD Sharing Statement

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Transcutaneous Auricular Vagus Nerve Stimulation for Meniere Disease

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