Headache Clinical Trial
Official title:
Efficacy of a Transcranial Vibrating System for Mitigation of Outcomes of Migraine Associated Vertigo
Verified date | April 2021 |
Source | Otolith Labs |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
Status | Suspended |
Enrollment | 40 |
Est. completion date | December 30, 2021 |
Est. primary completion date | December 30, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | 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: 1. History of head injury within the last six months or currently suffering the effects of a head injury 2. Presence of severe aphasia 3. History of diagnosed neuropsychiatric disorders (e.g. hypochondriasis, major depression, schizophrenia) 4. Documented neurodegenerative disorders 5. Pregnancy [Female candidates will be asked if they are pregnant] 6. Prior disorders of hearing and balance including: 1. Ménière's disease 2. Multiple sclerosis 3. Vestibular neuritis 4. Vestibular schwannoma 5. Sudden sensorineural hearing loss 7. History of Cerebrovascular disorders 8. History of ear operation other than myringotomy and tube placement in the past 9. Planned major surgery of the skull base (for instance, cochlear implant) 10. Systemic disorders to include chronic renal failure, cirrhosis of the liver, autoimmune disease, heart disease, lung disease, or severe arthritis 11. Individuals who cannot provide informed consent |
Country | Name | City | State |
---|---|---|---|
United States | Thomas Jefferson Hospital | Philadelphia | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Otolith Labs |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in vertigo symptoms | Questionnaire for vertigo symptoms from 0 (none) to 10 (agonizing) | 2 minutes and 20 minutes after starting the Otoband; and 20 minutes after stopping the Otoband | |
Primary | Brain confusion | Questionnaire for brain confusion: scale from 0 (none) to 10 (maximum) for the 4 following symptoms: forgetful, difficulty thinking/finding words, difficulty focusing, cloudy. | 2 minutes and 20 minutes after starting the Otoband; and 20 minutes after stopping the Otoband | |
Secondary | Change in nausea symptoms | Questionnaire for nausea symptoms from 0 (none) to 10 (agonizing) | 2 minutes and 20 minutes after starting the Otoband; and 20 minutes after stopping the Otoband | |
Secondary | Change in headache symptoms | Questionnaire for nausea symptoms from 0 (none) to 10 (worst pain possible) | 2 minutes and 20 minutes after starting the Otoband; and 20 minutes after stopping the Otoband |
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