Transcranial Magnetic Stimulation for Mal de Debarquement Syndrome
|ClinicalTrials.gov Identifier: NCT02470377|
Recruitment Status : Active, not recruiting
First Posted : June 12, 2015
Last Update Posted : January 28, 2020
|Condition or disease||Intervention/treatment||Phase|
|Mal de Debarquement Syndrome||Device: Transcranial Magnetic Stimulation||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||300 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Transcranial Magnetic Stimulation for Mal de Debarquement Syndrome|
|Study Start Date :||January 2012|
|Estimated Primary Completion Date :||January 2022|
|Estimated Study Completion Date :||January 2022|
Experimental: Transcranial Magnetic Stimulation
After determination of the motor threshold, the TMS coil will be positioned at predetermined locations over the brain using MRI guidance and a frameless stereotaxy system. A train of stimulation pulses (repetitive TMS) at 1Hz up to 10Hz or in theta burst mode will be delivered at one or more locations over the head, depending on the brain location under study (brain locations determined by MRI data). Real or active sham conditions will be used in the study but all participants will receive real treatment at some point during their enrollment. Real rTMS over one area may also be compared to real rTMS over another area.
Device: Transcranial Magnetic Stimulation
A form of external neuromodulation using pulsatile magnetic fields on the surface of the head.
- Dizziness Handicap Inventory [ Time Frame: 10 years ]This is a well validated 100 point self-reported scale with Functional, Physical, and Emotional components.
- Mal de Debarquement Balance Rating Scale [ Time Frame: 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 [ Time Frame: 10 years ]This is a well validated 42 point self-reported scale of anxiety and dizziness.
- SF-12 [ Time Frame: 10 years ]Well-established Quality of Life Scale
- Motion Sickness Susceptibility Scale [ Time Frame: 10 years ]Measures motion sickness susceptibility before and after age 12
- Neo-Five Factor Inventory [ Time Frame: 10 years ]Quantifies the five major personality traits
- Empathy Quotient [ Time Frame: 10 years ]40-item online or 20-item abbreviated scale to determine strength of empathic traits
- Functional Activities Scale [ Time Frame: 10 years ]Measures comfort with doing some basic activities of daily living
- Memory Questionnaire [ Time Frame: 10 years ]Measures subjective impressions of prospective and retrospective memory
- Multidimensional Fatigue Inventory [ Time Frame: 10 years ]Measures general, physical, and mental fatigue
- Edinburgh Handedness Scale [ Time Frame: 10 years ]Standard measure of handedness
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02470377
|United States, Minnesota|
|University of Minnesota|
|Minneapolis, Minnesota, United States, 55414|
|Principal Investigator:||Yoon-Hee Cha||University of Minnesota|