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

NCT03886012 | Suspended

• 1 other identifier: OLith10401
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Dizziness; Nausea; Headache; Confusion

Keywords

Migraine Associated Vertigo

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (2)

• Change in nausea symptoms

  2 minutes and 20 minutes after starting the Otoband; and 20 minutes after stopping the Otoband

• Change in headache symptoms

  2 minutes and 20 minutes after starting the Otoband; and 20 minutes after stopping the Otoband

Study Arms (2)

Otoband efficacy on vertigo

EXPERIMENTAL

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.

Device: Otoband

Otoband sham efficacy on vertigo

SHAM COMPARATOR

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.

Device: Otoband sham

Interventions

Otoband DEVICE

The Otoband will be used by participants during migraine associated vertigo (MAV). We expect the research subjects to use the device for at least 20 minutes, with the hardware limiting any one session to a duration of 30 minutes, up to 4 times per calendar day. The Otoband will be set to the effective power level during the course of a given calendar day.

Otoband efficacy on vertigo

Otoband sham DEVICE

The Otoband will be used by participants during migraine associated vertigo (MAV) for a maximum of 30 minutes, up to 4 times per calendar day. The Otoband will be set to an ineffective power level (considered a sham device) during the course of a given calendar day.

Otoband sham efficacy on vertigo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Otolith Labs: lead

Study Sites (1)

Thomas Jefferson Hospital

Philadelphia, Pennsylvania, 19107, United States

Location

MeSH Terms

Conditions

Dizziness; Nausea; Headache; Confusion

Condition Hierarchy (Ancestors)

Sensation Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive; Pain; Neurobehavioral Manifestations; Nervous System Diseases

Study Officials

• Dennis Fitzgerald, MD

  Jefferson University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Neither the subject nor the investigators in the study will know the calendar's schedule for normal or placebo power levels. At both settings, the device will be felt to vibrate, making it unlikely that participants will be able to guess which setting is effective and which is ineffective.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Subjects will be given the transcranial vibrating system (the Otoband) to use when they have migraine associated vertigo (MAV). The Otoband will function for up to 4 periods of 30 minutes per day, at one of two possible pre-set power levels. The possible power levels are A) a level deemed to be effective, or B) a placebo (ineffective) power level. On a given calendar day, the power level remains constant. The sponsor will provide Otobands with a predetermined, randomly assigned power schedule based on calendar day. Subjects will use the Otoband during each MAV episode. They will fill out questionnaires about associated symptoms (dizziness, nausea, headache, brain confusion) 2 \& 20 minutes after using turning the Otoband on, and 20 minutes after they stop using the Otoband. Outcomes measured will be compared between days with device at effective versus placebo power to determine if the Otoband affects dizziness, nausea, headache and brain confusion symptoms during MAV attacks.

Study Record Dates

• First Submitted: March 20, 2019
• First Posted: March 22, 2019
• Study Start: April 26, 2019
• Primary Completion: December 30, 2021
• Study Completion: December 30, 2021
• Last Updated: April 27, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)