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

NCT06267924 | Completed DMC FDA Device

• 1 other identifier: Olith10703
• Study Type: interventional
• Target: 322
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• DHI Change in Scores

  Reduction in final "Dizziness Handicap Inventory" (DHI) score by at least 12 points, compared to transition DHI score

  Day 23 - Day 51

Secondary Outcomes (5)

• Number of related adverse events

  Day 23 - Day 51

• Change in number of vestibular migraine episodes weekly

  Day 1 - Day 51

• Global Impression of Change (severity of episodes)

  Day 51

• DHI change from transition to end of study

  Day 23 - Day 51

• Device responder rate

  Day 23 - Day 51

Study Arms (2)

1. Moderate or Worse (MoW) Arm

EXPERIMENTAL

Participants will be randomized to use the Otoband as instructed by clinical coordinator per study protocol. These participants will receive the experimental treatment device.

Device: Otoband Experimental

2. Moderate or Worse (MoW) Arm

SHAM COMPARATOR

Participants will be randomized to use the Otoband as instructed by clinical coordinator per study protocol. These participants will receive the sham device.

Device: Otoband Sham

Interventions

Otoband Experimental DEVICE

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

1. Moderate or Worse (MoW) Arm

Otoband Sham DEVICE

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

2. Moderate or Worse (MoW) Arm

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Females who are pregnant or trying to become pregnant
• 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
• History of vitreous detachment in the last 90 days
• Superior canal dehiscence or otic capsule dehiscence
• Diagnosed hyperacusis
• Planning to start vestibular rehabilitation therapy during the study
• History of cerebrovascular disorders
• Posterior fossa tumors, vestibular schwannoma
• Cerebellar degeneration (progressive worsening of neurons behind the brain stem)
• Initiation of calcitonin gene-related peptide inhibitor treatment within 4 weeks prior to beginning of trial
• Cognitive impairment or inability to follow study procedures

Sponsors & Collaborators

• Otolith Labs: lead
• MCRA: collaborator

Study Sites (1)

Otolith Labs

Washington D.C., District of Columbia, 20001, United States

Location

Study Officials

• Didier Depireux, PhD

  Otolith Labs

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Clinical Research Coordinators, Clinical Trial Manager, Clinical Team Lead, and other members of the Sponsor organization.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The proposed clinical trial for the study device will be a randomized, sham-controlled, double-blind study with two-parallel arms (active/sham device).

Study Record Dates

• First Submitted: February 12, 2024
• First Posted: February 20, 2024
• Study Start: March 6, 2024
• Primary Completion: December 9, 2024
• Study Completion: January 8, 2025
• Last Updated: January 30, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)