Transcranial Electrical Stimulation for Mal de Debarquement Syndrome

University of Minnesota

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Conditions

Mal de Debarquement Syndrome

Interventions

Transcranial Electrical StimulationDEVICE

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

University of Minnesota

Minneapolis, Minnesota, United States

Outcomes

Primary Outcomes

Dizziness Handicap Inventory

This is a well validated 100 point self-reported scale with Functional, Physical, and Emotional components.

Time frame: 10 years

Secondary Outcomes

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.

Time frame: 10 years

Hospital Anxiety and Depression Scale

This is a well validated 42 point self-reported scale of anxiety and dizziness.

Time frame: 10 years

Data from ClinicalTrials.gov

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