Efficacy of a Transcranial Vibrating System for Mitigation of Migraine Associated Vertigo

Paused · Not applicable · Has a placebo group

Conditions studied: Dizziness, Nausea, Headache, Confusion

In brief

Vertigo is among the most common symptoms associated with migraine and affects 26.5% of migraine sufferers, leading to a dramatic impact in life limiting even the most simple activities. A new device, the OtoBand, a transcranial vibrating system, has been shown to mitigate and sometimes prevent vertigo and nausea in healthy subjects. The current study aims to determine if the Otoband can treat or reduce symptoms of Migraine Associated Vertigo (MAV).

Key facts

Study ID

NCT03886012

Run by

Otolith Labs

People needed

40

Starts

2019-04-26

Expected to finish

2021-12-30

Last updated by the study team

2021-04-27

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subject between the ages of 18-65 with a history of frequent Migraine Associated Vertigo (MAV) attacks as characterized by the following:
• An episode with acute onset vertigo that lasted at least 15 minutes within the previous 30 days.
• At least 5 such episodes in the past 12 months.

You may not qualify if…

• History of head injury within the last six months or currently suffering the effects of a head injury
• Presence of severe aphasia
• History of diagnosed neuropsychiatric disorders (e.g. hypochondriasis, major depression, schizophrenia)
• Documented neurodegenerative disorders
• Pregnancy [Female candidates will be asked if they are pregnant]
• Prior disorders of hearing and balance including:
• Ménière's disease
• Multiple sclerosis
• Vestibular neuritis
• Vestibular schwannoma
• Sudden sensorineural hearing loss
• History of Cerebrovascular disorders
• History of ear operation other than myringotomy and tube placement in the past
• Planned major surgery of the skull base (for instance, cochlear implant)
• Systemic disorders to include chronic renal failure, cirrhosis of the liver, autoimmune disease, heart disease, lung disease, or severe arthritis
• Individuals who cannot provide informed consent

Where it is running

• Thomas Jefferson Hospital — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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