WAVES for Mal de Debarquement Syndrome

NCT04612010 | Withdrawn Early Phase 1

• 1 other identifier: NEUR-2020-29419
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study will be recruiting individuals with Mal de Debarquement Syndrome (MdDS), a disorder caused by entrainment to oscillating motion that leads to persistent oscillating vertigo. The typical triggers for MdDS are sea and air travel. Prior studies on MdDS have shown that functional connectivity measured by both EEG and fMRI decreases when symptoms of MdDS improve. This study seeks to use asynchronous visual and auditory stimulation provided through a smart-phone app (WAVES) administered through virtual reality goggles to modulate the vertigo in MdDS with the hypothesis that these stimuli can desynchronize functional connectivity.

Conditions

Mal de Debarquement Syndrome

Outcome Measures

Primary Outcomes (1)

• MdDS Balance Rating Scale (MBRS)

  This is a 10 point self-reported scale that assesses the severity of rocking dizziness and its effect on balance function. The scale goes from 1 to 10 with 1 representing no feeling of motion and 10 representing motion severity so strong that standing is not possible.

  5 years

Secondary Outcomes (3)

• Visual Analogue Scale

  5 years

• Hospital Anxiety Depression Scale

  5 years

• Dizziness Handicap Inventory

  5 years

Other Outcomes (1)

• Electroencephalography (EEG)

  5 years

Study Arms (3)

Alpha frequency

ACTIVE COMPARATOR

Wobble oscillation will revolve the individual alpha frequency

Device: WAVES (Wobble-oscillator Auditory/Visual Excitatory Stimulation)

Alpha frequency plus

ACTIVE COMPARATOR

Wobble oscillation will revolve the individual alpha frequency plus 0.5Hz

Device: WAVES (Wobble-oscillator Auditory/Visual Excitatory Stimulation)

Theta frequency

SHAM COMPARATOR

Wobble oscillation will revolve the individual theta frequency

Device: WAVES (Wobble-oscillator Auditory/Visual Excitatory Stimulation)

Interventions

WAVES (Wobble-oscillator Auditory/Visual Excitatory Stimulation) DEVICE

An app-based stimulation program administered that provides desynchronizing visual and auditory stimulation. The frequency of the stimulation oscillates around the baseline frequency determined by EEG.

Also known as: WAVES

Alpha frequency; Alpha frequency plus; Theta frequency

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Persistent oscillating vertigo that occurs within 48-hours of disembarking from a moving vessel such as a boat, car, or plane, 2. Symptoms improve with exposure to passive motion, 3. No other cause for symptoms after evaluation by a neurologist or otolaryngologist.

You may not qualify if:

• \. History of epilepsy. 2. Structural brain injury such as stroke, brain tumor, or confluent white matter lesions. 3. Unstable medical or psychiatric condition. 4. Pregnant or planning to become pregnant during the study duration. 5. Not able to comply with all study procedures.

Sponsors & Collaborators

• University of Minnesota: lead

MeSH Terms

Conditions

Mal de debarquement

Study Officials

• Yoon-Hee Cha, MD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Each arm involves real stimulation but only one is consistent with the hypothesis of desynchronization. The participant will not be aware of which administration is providing the target frequency of stimulation.
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The participants will be in an n-of-1 design with each participant receiving each frequency of stimulation in a randomized blinded order.

Study Record Dates

• First Submitted: October 26, 2020
• First Posted: November 2, 2020
• Study Start: March 1, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: May 9, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: 5 years
• Access Criteria: Well-established or working under the supervision of a well-established researcher in the neurosciences with adequate justification for accessing the data under an appropriate data sharing agreement.