Transcranial Electrical Stimulation for Mal de Debarquement Syndrome

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.

Study Overview

• Status: Withdrawn
• Conditions: Mal de Debarquement Syndrome
• Intervention / Treatment: Device: Transcranial Electrical Stimulation

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.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55414
      • University of Minnesota

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Transcranial Electrical Stimulation-Real; 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; 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.; Other Names: Transcranial Direct Current Stimulation (tDCS); Transcranial Alternating Current Stimulation (tACS); Transcranial Random Noise Stimulation (tRNS); Sham Transcranial Stimulation
Sham Comparator: Transcranial Electrical Stimulation-Sham; 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; 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.; Other Names: Transcranial Direct Current Stimulation (tDCS); Transcranial Alternating Current Stimulation (tACS); Transcranial Random Noise Stimulation (tRNS); Sham Transcranial Stimulation

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: University of Minnesota
• Investigators: Principal Investigator: Yoon-Hee Cha, MD, University of Minnesota

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: September 1, 2013
• Primary Completion (Anticipated): December 1, 2022
• Study Completion (Anticipated): December 1, 2022

Study Registration Dates

• First Submitted: September 2, 2015
• First Submitted That Met QC Criteria: September 3, 2015
• First Posted (Estimate): September 4, 2015

Study Record Updates

• Last Update Posted (Actual): March 16, 2023
• Last Update Submitted That Met QC Criteria: March 13, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: TMS; TES; MdDS
• Additional Relevant MeSH Terms: Pathologic Processes; Disease; Syndrome
• Other Study ID Numbers: 2013-006-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Anonymized data will be shared once recruitment is sufficient to prevent the inadvertent identification of participants by demographic or clinical characteristics