Transcranial Electrical Stimulation for Mal de Debarquement Syndrome

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.

• Transcranial Electrical Stimulation (Device), also known as Transcranial Direct Current Stimulation (tDCS), Transcranial Alternating Current Stimulation (tACS), Transcranial Random Noise Stimulation (tRNS), Sham Transcranial 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.

Primary outcomes

• Dizziness Handicap Inventory [10 years]: This is a well validated 100 point self-reported scale with Functional, Physical, and Emotional components.

Secondary outcomes

• 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 outcomes

• 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
• 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
• Functional Activities Scale [10 years]: Measures comfort with doing some basic activities of daily living
• Memory Questionnaire [10 years]: Measures subjective impressions of prospective and retrospective memory
• Multidimensional Fatigue Inventory [10 years]: Measures general, physical, and mental fatigue
• Edinburgh Handedness Scale [10 years]: Standard measure of handedness

Sex: All, ages: 18 Years to any

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

• Results publication: 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. PMID 35120184

• Yoon-Hee Cha, MD, Principal investigator, University of Minnesota