MedTrace Logo

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

NCT06267924 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 322

Last updated 2025-01-30

No results posted yet for this study

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.

Conditions

  • Vestibular Migraine
  • Migraine Associated Vertigo

Interventions

DEVICE

Otoband Experimental

Participants will be randomly assigned to use the Otoband Experimental device to determine effectiveness in providing temporary relief to symptoms of vertigo.

DEVICE

Otoband Sham

Participants will be randomly assigned to use the Otoband Sham device to determine effectiveness in providing temporary relief to symptoms of vertigo.

Sponsors & Collaborators

  • MCRA

    collaborator INDUSTRY

  • Otolith Labs

    lead INDUSTRY

Principal Investigators

  • Didier Depireux, PhD · Otolith Labs

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-06
Primary Completion
2024-12-09
Completion
2025-01-08
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06267924 on ClinicalTrials.gov