Clinical trial NCT02540616: Transcranial Electrical Stimulation for Mal de Debarquement Syndrome
Official title: Transcranial Electrical Stimulation for Mal de Debarquement Syndrome
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Mal de Debarquement Syndrome
Keywords: MdDS
TES
TMS
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2015-09-04
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Dizziness Handicap Inventory
timeFrame: 10 years
Secondary outcomes:
measure: Mal de Debarquement Balance Rating Scale
timeFrame: 10 years
measure: Hospital Anxiety and Depression Scale
timeFrame: 10 years
Other outcomes:
measure: SF-12
timeFrame: 10 years
measure: Motion Sickness Susceptibility Scale
timeFrame: 10 years
measure: Neo-Five Factor Inventory
timeFrame: 10 years
measure: Empathy Quotient
timeFrame: 10 years
measure: Functional Activities Scale
timeFrame: 10 years
measure: Memory Questionnaire
timeFrame: 10 years
measure: Multidimensional Fatigue Inventory
timeFrame: 10 years
measure: Edinburgh Handedness Scale
timeFrame: 10 years
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Yoon-Hee Cha, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.