SENSE-VM: Safety and Effectiveness of a Novel Medical Device for Symptom Ease in Vestibular Migraines

Vestibular Migraine Clinical Trial

Official title: SENSE-VM: Safety and Effectiveness of a Novel Medical Device for Symptom Ease in Vestibular Migraines

Status Enrolling by invitation

Clinical Trial Summary

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.

Clinical Trial Description

This study is a decentralized clinical trial. This study uses technology and virtual meetings to communicate with study participants and collect study data. This study seeks to enroll until 200 participants have completed the study per protocol.

Study participants that meet all of the inclusion, none of the exclusion criteria, and sign informed consent will be enrolled in the study. Participants will complete a one day enrollment meeting and a 14 day Baseline Phase.

If a participant is eligible to remain in the study for the Treatment Phase at day 15, they will be randomized within their assigned group at a 1:1 ratio to an Active arm or Sham arm to begin the Treatment Phase of the study. Participants will be sent a study device to use when they have a vertigo episode.

Participants that enroll in the study are expected to participate up to 50 days with virtual meetings at the approximate intervals:

Day 15, Day 22, Day 25, Day 35, and Day 50

Participants will be required to complete the DHI (Dizziness Handicap Inventory), VM-PATHI (Vestibular Migraine Patient Assessment Tool and Handicap Inventory), General Vertigo History, Global Impression of Change, "Most Bothersome Symptom", Relief from "Most Bothersome Symptom", and Net promoter score questionnaires.

Otolith Labs received Therapeutic Breakthrough Device designation by the FDA in May, 2021. ;

Related Conditions & MeSH terms

• Migraine Disorders
• Vertigo
• Vestibular Migraine

• NCT number: NCT06267924
• Study type: Interventional
• Source: Otolith Labs
• Status: Enrolling by invitation
• Phase: N/A
• Start date: February 28, 2024
• Completion date: September 30, 2024