Clinical trial NCT04612010: WAVES for Mal de Debarquement Syndrome
Official title: WAVES: Wobble-oscillator Auditory/Visual Excitatory Stimulation for Mal de Debarquement Syndrome
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: EARLY_PHASE1
Conditions: Mal de Debarquement Syndrome
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2020-11-02
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: The participants will be in an n-of-1 design with each participant receiving each frequency of stimulation in a randomized blinded order.
Primary purpose: DEVICE_FEASIBILITY

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.

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.

Primary outcomes:
measure: MdDS Balance Rating Scale (MBRS)
timeFrame: 5 years
Secondary outcomes:
measure: Visual Analogue Scale
timeFrame: 5 years
measure: Hospital Anxiety Depression Scale
timeFrame: 5 years
measure: Dizziness Handicap Inventory
timeFrame: 5 years
Other outcomes:
measure: Electroencephalography (EEG)
timeFrame: 5 years
Locations:
Study officials:
affiliation: University of Minnesota
name: Yoon-Hee Cha, MD
role: PRINCIPAL_INVESTIGATOR
References: