NCT06267924Completed
SENSE-VM: Safety and Effectiveness of a Novel Medical Device for Symptom Ease in Vestibular Migraines
Source: ClinicalTrials.gov · Last updated 30 Jan 2025
Brief summary (registry, in English)
The goal of this virtual clinical trial is to compare the effectiveness of two study devices in providing temporary relief to adults aged 18-75 who suffer from symptoms of chronic Vestibular Migraines (VM), also known as Migraine Associated Vertigo. Participants will be: * Enrolled up to 50 days; enrollment, 14 days in Baseline Phase (no device), 7 days in Transition Phase, 28 days in Treatment Phase (study device) * Randomized and stratified into groups based on the referring clinic to be assigned one study device * Asked to use the study device as instructed by the study coordinator * Asked to submit daily diaries reporting their symptoms and use of device, and to participate in tele-health visits with study coordinators * Asked to provide their vertigo diagnosis from their physician * Compensated for their participation Researchers will compare the randomized groups to determine which group responds better to which device.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 322 (actual)
- First submitted
- 12 Feb 2024
- Start date
- 6 Mar 2024
- Primary completion date
- 9 Dec 2024
- Lead sponsor
- Otolith Labs
- Diseases
- Migraine
- NCT number
- NCT06267924
What you commit to
- Study type: Interventional
- Participants enrolled: 322
- From 6 Mar 2024 to the primary completion date, 9 Dec 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Enrolled in previous Otolith Lab-sponsored clinical trial
- Currently taking part in another interventional trial
- Surgery to the skull base within the last 6 months or plans for surgery to the skull during enrollment period
- Skull or neck implants
- Planning to start vestibular rehabilitation therapy during the study
- Initiation of calcitonin gene-related peptide inhibitor treatment within 4 weeks prior to beginning of trial
Other illness
- History of vitreous detachment in the last 90 days
- History of cerebrovascular disorders
- Cognitive impairment or inability to follow study procedures
Other
- Females who are pregnant or trying to become pregnant
- Superior canal dehiscence or otic capsule dehiscence
- Diagnosed hyperacusis
- Posterior fossa tumors, vestibular schwannoma
- Cerebellar degeneration (progressive worsening of neurons behind the brain stem)
Who the study is looking for
- To be eligible to participate in this study, an individual must meet all the following criteria:
- \- Diagnosed as having Vestibular Migraine (VM) (aka Migraine Associated Vertigo) The participant's diagnosis must be provided by a physician, Board certified in Otolaryngology or Neurology, from one of the study's approved clinics.
- Diagnosis for VM must follow Bárány Society's "International Classification of Vestibular Disorders", which contains the Society's consensus diagnostic criteria for VM \[Lempert 2022, sect. 3\].
- Male or female subjects, age 18 to 75 years old inclusive on day of enrollment
- Residing in the United States
- Vestibular migraines that have been recurrent for at least 90 days
- Score from 36 to 90 inclusive on the Dizziness Handicap Inventory (DHI) (corresponding to moderate to severe vertigo)
- A smartphone, computer or tablet and access to internet to complete study procedures and study meetings
- Willing and able to comply with study procedures
- Willingness to use Venmo or Paypal for study stipend
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Otolith Labs Coordinator of this site? Confirm its status | Washington D.C. | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.