Transcranial Electrical Stimulation for Mal de Debarquement Syndrome

Study Overview
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Brief Summary
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The goal of this study is to determine whether external neuromodulation using transcranial electrical stimulation (TES) can reduce the perception of self-motion that is experienced by patients with MdDS. Mal de debarquement is translated as the sickness of disembarkment, and refers to the chronic feeling of rocking dizziness that occurs after exposure to passive motion. A similar form of rocking dizziness can be experienced without a motion trigger in individuals with certain risk factors. Treatment for MdDS is limited and morbidity is high.The goal of the study is to determine whether TES can suppress the rocking dizziness of MdDS either as a standalone therapy or as an adjunctive therapy to other forms of neuromodulation such as transcranial magnetic stimulation. The investigators will determine the optimal treatment duration and stimulation parameters.

Detailed Description
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Eligible participants who meet study criteria and pass the safety screen will be invited to participate in the study. If TES is used as add-on treatment to repetitive transcranial magnetic stimulation (rTMS), the training for TES application will be done on-site. However, in a portion of the study that does not involve rTMS, remote training will be performed via a webcam provided that a suitable Study Buddy is available to assist the participant. Participants will maintain web-based diaries of their symptoms for up to four weeks prior to treatment with TES. Before the actual treatment sessions are started, the subjects will complete baseline questionnaires online which will be repeated once a week for up to 12 weeks. Over the course of the study, the subjects will also keep a daily log of their sessions such as how many sessions they performed, for how long, and whether they had any side effects with each session. The studies will include a sham arm, allocated at a ratio of 1:1. On-site studies will involve the application of EEG, MRI, balance, cognitive, and visual/auditory stimulation tests.

Official Title
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Transcranial Electrical Stimulation for Mal de Debarquement Syndrome

Conditions
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Mal de Debarquement Syndrome

Intervention / Treatment
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* Device: Transcranial Electrical Stimulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥18 years old Willing and capable of interacting with the informed consent process Primary disorder being a persistent perception of motion with no other cause determined after a careful interview. Able to identity a study buddy and provide contact information Exclusion Criteria: Subjects who cannot comply with study conditions. Active psychiatric condition such as mania or psychosis Unstable medical condition Implanted metal in the head or neck (metal or shrapnel, deep brain stimulators, aneurysm clips, cochlear stimulators, retinal implants, etc). Dental fillings are acceptable. Any active skin disorder that affects skin integrity of the scalp. Pregnant

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Participants will be randomized to a real vs a sham stimulation arm. The sham arm will be offered real treatment after unblinding.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Transcranial Electrical Stimulation-Real<br>The participant will perform real TES. The forms of TES used in this study will include transcranial direct current stimulation (tDCS), transcranial alternating current stimulation (tACS), or transcranial random noise stimulation (tRNS). Each stimulation session will last for 20-minutes. | Device: Transcranial Electrical Stimulation<br>* A form of external neuromodulation using electrodes on the surface of the head. We will be using the TCT tDCS device (www.trans.cranial.com) or devices constructed by our research group or collaborators.<br>* Other names: Sham Transcranial Stimulation;|
| Sham Comparator: Transcranial Electrical Stimulation-Sham<br>The participant will perform sham TES for 20-minutes. The form of sham TES will depend on the active arm, e.g. if tACS is on the active arm, then the sham tACS will be a different frequency of stimulation. If tDCS is the active arm, then a short ramp up of tDCS followed by a ramp down (about 60-seconds) will be used as the sham arm. | Device: Transcranial Electrical Stimulation<br>* A form of external neuromodulation using electrodes on the surface of the head. We will be using the TCT tDCS device (www.trans.cranial.com) or devices constructed by our research group or collaborators.<br>* Other names: Sham Transcranial Stimulation;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dizziness Handicap Inventory | This is a well validated 100 point self-reported scale with Functional, Physical, and Emotional components. | 10 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mal de Debarquement Balance Rating Scale | This is a 10 point self-reported scale that assesses the severity of rocking dizziness and its effect on balance function. | 10 years | 
| Hospital Anxiety and Depression Scale | This is a well validated 42 point self-reported scale of anxiety and dizziness. | 10 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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MdDS, TES, TMS