Health TrialsbyHealthPanel

Modulating Auditory Symptoms and Vertigo of Meniere's Disease by Non-invasive Mastoid Electric Stimulation

ConditionMeniere's Disease
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age19-80
SponsorSeoul National University Hospital

About this trial

This study is a Double-blind, Randomized, Sham-controlled, Investigator-initiated trial. To explore the effectiveness of non-invasive inner ear electrical stimulation of the mastoid behind the ear in controlling auditory symptoms and dizziness in patients with Meniere's disease.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients with dizziness (Meniere's) only, who understand the nature of the study and are willing to participate voluntarily.

The frequency of the hearing loss is between 250 kHz and 1 kHz.

Patients with bilateral 500, 1000, and 2000 Hz hearing threshold averages within 65 dB HL

Patients who have received conventional pharmacotherapy for other dizziness conditions with a washout period of 2 months.

Disqualifiers

Patients with an otologic condition other than Meniere'ss (dizziness) (otitis media, profound hearing loss, hyperacusis, etc.).

Patients' conditions that may affect EEG measurements, such as a stroke, brain hemorrhage, or brain tumor.

Patients with kidney disease

Patients Have or have had a serious medical condition, such as cancer (including leukemia, blood cancers, epilepsy, and neuropsychiatric conditions).

Trial design

Design model

Parallel

Treatments tested in this trial

  • YPS-201b

    Device

    electrical stimulation device.

  • betahistine

    Drug

    Relieve symptoms of balance disorders or dizziness

  • YPS-201b

    Device

    sham electrical stimulation device.

Treatment groups

120 Participants
are divided into 3 treatment groups
Group A: electircal stimulation + betahistineExperimental treatment 2 interventions
Group B: sham electircal stimulation + betahistineSham comparator 2 interventions
Group C: betahistineOther 1 intervention

Trial outcomes

Primary outcomes

1

Valuation of dizziness with Dizziness Visual Analogue scale(Efficacy)

Verifying therapeutic effect of electrical stimulation

Time frame
0,2,4,8,12 weeks during electrical stimulation
2

Evaluate vestibular-ocular reflex with Video head impulse test(Efficacy)

Verifying therapeutic effect of electrical stimulation,evaluate the function of the vestibulocochlear reflex in the semicircular canal and measure the extent of improvement in Meniere's disease.

Time frame
0,4,8,12 weeks during electrical stimulation
3

Valuation of hearing threshold with pure tone audiometry(Efficacy)

Verifying therapeutic effect of electrical stimulation.measuring the level of enhancement in low-frequency hearing.

Time frame
0,4,8,12 weeks during electrical stimulation
4

electroencephalography(Efficacy)

Verifying therapeutic effect of electrical stimulation,evaluate the inhibitory response of the brain through EEG readings following repeated stimulation.

Time frame
0,1,4,8,12 weeks during electrical stimulation

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Seoul National University Hospital

Lead sponsor

Source ClinicalTrials.gov
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