WAVES for Mal de Debarquement Syndrome

NCT ID: NCT04612010

Last Updated: 2023-05-09

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: EARLY_PHASE1
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-01
• Study Completion Date: 2026-12-31

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.

Detailed Description

The main device class used in this study will be an app that was designed by one of the investigators. The app is called "WAVES" and can be run on either an Android or iOS platform. The program presents a split screen of flashing lights with a different frequency on each half screen. The frequency of the lights can be changed according to either standard parameters or parameters set by EEG metrics. Audio stimulation will also be added in a second phase of the study. The audio stimulation consists of clicks given to each ear at different frequencies.

The study will have several stages. The participants will be told what stage of the project they will be participating in.

Stage 1: Open-label feasibility-this stage will include about 10-15 individuals who will be test participants for new protocols. This may include change in frequency of stimulation around a new baseline such as the individual theta frequency or the individual alpha frequency. All session parameters will be restricted, e.g. no more than 40-minutes of total stimulation per session.

Stage 2: Sham controlled single-blind randomized onsite. This stage will include participants who receive up to 40-minutes of visual stimulation given either through a protocol determined in Stage 1 as an effective paradigm or as random frequency stimulation. The participants will be blinded to study allocation. The principal investigator will not be blinded in order to have tighter oversight on safety.

Stage 3: Sham controlled double-blind randomized at home with cross over study. This stage will involve sending the participants home with a smartphone app and pre-fitted head mounted virtual reality frame. The participants will receive a kit that contains the accessories and smartphone. Allocation will be 1:1 real to sham stimulation. After a preset trial duration (generally 2-weeks) the participants who were give sham stimulation will be cross-overed to real stimulation. The individuals who underwent real stimulation will be cross-overed to sham stimulation for 2 weeks. Both will then be given the option of doing 2 weeks of open label stimulation and then tapered to off over 2 weeks. This will provide an assessment of stimulation efficacy of 2 weeks vs 4 weeks as well as the sham response rate. Each week of sessions entails 5-10 sessions per week.

The participants will be completing online study questionnaires through a personalized weblink on RedCap or SurveyMonkey.

EEG recordings will be made at baseline, conclusion, and in between sessions to monitor the correlation between symptoms and EEG features.

Conditions

Mal de Debarquement Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: DEVICE_FEASIBILITY
• Blinding Strategy: SINGLE

Study Groups

Alpha frequency

Wobble oscillation will revolve the individual alpha frequency

Group Type: ACTIVE_COMPARATOR

WAVES (Wobble-oscillator Auditory/Visual Excitatory Stimulation)

Intervention Type: 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.

Alpha frequency plus

Wobble oscillation will revolve the individual alpha frequency plus 0.5Hz

Group Type: ACTIVE_COMPARATOR

WAVES (Wobble-oscillator Auditory/Visual Excitatory Stimulation)

Intervention Type: 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.

Theta frequency

Wobble oscillation will revolve the individual theta frequency

Group Type: SHAM_COMPARATOR

WAVES (Wobble-oscillator Auditory/Visual Excitatory Stimulation)

Intervention Type: 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.

Interventions

WAVES (Wobble-oscillator Auditory/Visual Excitatory Stimulation)

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.

Intervention Type: DEVICE

Other Intervention Names

WAVES

Eligibility Criteria

Inclusion Criteria

• 1. 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.

Exclusion Criteria

• 1. 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Minnesota

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yoon-Hee Cha, MD

Role: PRINCIPAL_INVESTIGATOR

University of Minnesota

Other Identifiers

NEUR-2020-29419

Identifier Type: -

Identifier Source: org_study_id