Efficacy of a Transcranial Vibrating System for Mitigation of Migraine Associated Vertigo
Dizziness, Nausea, Headache
About this trial
This is an interventional treatment trial for Dizziness focused on measuring Migraine Associated Vertigo
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
- 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
Sites / Locations
- Thomas Jefferson Hospital
Arms of the Study
Arm 1
Arm 2
Experimental
Sham Comparator
Otoband efficacy on vertigo
Otoband sham efficacy on vertigo
Participants will be given the transcranial vibrating system (Otoband) to be used during migrane associated vertigo (MAV) attacks. Participants will be able to use the Otoband up to 4 times, 30 minutes each time, per day. The Otoband will be set to the effective power level. Participants will fill out questionnaires about 4 symptoms associated to MAV: before, during (2 and 20 minutes after turning on the Otoband) and after the session (20 minutes after the Otoband was or has stopped). The conditions evaluated will be: dizziness, nausea, headache and brain confusion. Participants will complete questionnaires either online using secure HIPPA-compliant webforms, or using pre-printed questionnaires, as they prefer.
Participants will be given the transcranial vibrating system (Otoband) to be used during migrane associated vertigo (MAV) attacks. Participants will be able to use the Otoband up to 4 times, 30 minutes each time, per day. The Otoband will be set to an ineffective power level, serving as a placebo. Participants will fill out questionnaires about 4 symptoms associated to MAV: before, during (2 and 20 minutes after turning on the Otoband) and after the session (20 minutes after the Otoband was or has stopped). The conditions evaluated will be: dizziness, nausea, headache and brain confusion. Participants will complete questionnaires either online using secure HIPPA-compliant webforms, or using pre-printed questionnaires, as they prefer.