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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Transcranial Electrical Stimulation-Real | Experimental | 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. |
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| Transcranial Electrical Stimulation-Sham | Sham Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transcranial Electrical Stimulation | Device | 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. |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| SF-12 | Well established Quality of Life Scale | 10 years |
| Motion Sickness Susceptibility Scale | Measures motion sickness susceptibility before and after age 12 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yoon-Hee Cha, MD | University of Minnesota | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Minnesota | Minneapolis | Minnesota | 55414 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35120184 | Derived | Cha YH, Gleghorn D, Doudican BC. Double-blind randomized N-of-1 trial of transcranial alternating current stimulation for mal de debarquement syndrome. PLoS One. 2022 Feb 4;17(2):e0263558. doi: 10.1371/journal.pone.0263558. eCollection 2022. |
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Anonymized data will be shared once recruitment is sufficient to prevent the inadvertent identification of participants by demographic or clinical characteristics
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| ID | Term |
|---|---|
| C537840 | Mal de debarquement |
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| ID | Term |
|---|---|
| D065908 | Transcranial Direct Current Stimulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D003295 | Convulsive Therapy |
| D013000 | Psychiatric Somatic Therapies |
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Participants will be randomized to a real vs a sham stimulation arm. The sham arm will be offered real treatment after unblinding.
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This is a well validated 42 point self-reported scale of anxiety and dizziness.
| 10 years |
| 10 years |
| Neo-Five Factor Inventory | Quantifies the five major personality traits | 10 years |
| Empathy Quotient | 40 item online or 20 item abbreviated scale to determine strength of empathic traits | 10 years |
| Functional Activities Scale | Measures comfort with doing some basic activities of daily living | 10 years |
| Memory Questionnaire | Measures subjective impressions of prospective and retrospective memory | 10 years |
| Multidimensional Fatigue Inventory | Measures general, physical, and mental fatigue | 10 years |
| Edinburgh Handedness Scale | Standard measure of handedness | 10 years |
| D004191 | Behavioral Disciplines and Activities |
| D004597 | Electroshock |
| D011580 | Psychological Techniques |