Mal de Debarquement Syndrome
Conditions
Keywords
MdDS, TES, TMS
Brief summary
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
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.
Interventions
DEVICETranscranial Electrical Stimulation
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.
Sponsors
University of Minnesota
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Intervention model description
Participants will be randomized to a real vs a sham stimulation arm. The sham arm will be offered real treatment after unblinding.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age ≥18 years old 2. Willing and capable of interacting with the informed consent process 3. Primary disorder being a persistent perception of motion with no other cause determined after a careful interview. 4. Able to identity a study buddy and provide contact information
Exclusion criteria
1. Subjects who cannot comply with study conditions. 2. Active psychiatric condition such as mania or psychosis 3. Unstable medical condition 4. Implanted metal in the head or neck (metal or shrapnel, deep brain stimulators, aneurysm clips, cochlear stimulators, retinal implants, etc). Dental fillings are acceptable. 5. Any active skin disorder that affects skin integrity of the scalp. 6. Pregnant
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Dizziness Handicap Inventory | 10 years | This is a well validated 100 point self-reported scale with Functional, Physical, and Emotional components. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mal de Debarquement Balance Rating Scale | 10 years | This is a 10 point self-reported scale that assesses the severity of rocking dizziness and its effect on balance function. |
| Hospital Anxiety and Depression Scale | 10 years | This is a well validated 42 point self-reported scale of anxiety and dizziness. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Neo-Five Factor Inventory | 10 years | Quantifies the five major personality traits |
| Empathy Quotient | 10 years | 40 item online or 20 item abbreviated scale to determine strength of empathic traits |
| Edinburgh Handedness Scale | 10 years | Standard measure of handedness |
| Memory Questionnaire | 10 years | Measures subjective impressions of prospective and retrospective memory |
| Multidimensional Fatigue Inventory | 10 years | Measures general, physical, and mental fatigue |
| Functional Activities Scale | 10 years | Measures comfort with doing some basic activities of daily living |
| SF-12 | 10 years | Well established Quality of Life Scale |
| Motion Sickness Susceptibility Scale | 10 years | Measures motion sickness susceptibility before and after age 12 |
Countries
United States
Outcome results
None listed