Clinical Trial: Transcranial Magnetic Stimulation for Mal de Debarquement Syndrome

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Transcranial Magnetic Stimulation for Mal de Debarquement Syndrome

Brief Summary: The goal of this study is to determine whether external neuromodulation using repetitive transcranial magnetic stimulation (rTMS) can reduce the perception of self-motion that is experienced by individuals with mal de debarquement syndrome (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. Treatment for MdDS is limited and morbidity is high. The goal of the study is to determine whether rTMS can suppress the rocking dizziness of MdDS and to determine whether imaging and electrical biomarkers can aide in more effective targeting. The investigators will make correlations between functional magnetic resonance imaging (fMRI), electroencephalography (EEG), and specific clinical features to determine whether functional connectivity between particular hubs in the brain correlate with clinical improvement.

Detailed Summary: Participants will maintain web-based diaries of their symptoms for two weeks prior to treatment with rTMS. Up to 20 treatments with rTMS with either anatomically or functionally determined targets will be administered. Treatments will be preceded by an fMRI scan and EEG recording prior to the first rTMS treatment and will be followed by an fMRI and EEG after the last treatment. Post treatment diaries will continue for up to 12 weeks after rTMS administration.
Sponsor: Laureate Institute for Brain Research, Inc.

Current Primary Outcome: Dizziness Handicap Inventory [ Time Frame: 10 years ]

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


Original Primary Outcome: Dizziness Handicap Inventory [ Time Frame: 10 years ]

The DHI is a well validated scale with Functional, Physical, and Emotional components. It is based on a 100 point scale in which >54 points represents severe impairment.


Current Secondary Outcome:

  • 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.


Original Secondary Outcome:

  • Mal de Debarquement Balance Rating Scale [ Time Frame: 10 years ]
    This is a 10 point 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 14 item well validated self-reported scale of anxiety and dizziness.


Information By: Laureate Institute for Brain Research, Inc.

Dates:
Date Received: June 9, 2015
Date Started: January 2012
Date Completion: January 2022
Last Updated: March 6, 2017
Last Verified: March 2017