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Transcranial Magnetic Stimulation for Mal de Debarquement Syndrome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02470377
Recruitment Status : Active, not recruiting
First Posted : June 12, 2015
Last Update Posted : January 28, 2020
Sponsor:
Information provided by (Responsible Party):
Yoon-Hee Cha, University of Minnesota

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.

Condition or disease Intervention/treatment Phase
Mal de Debarquement Syndrome Device: Transcranial Magnetic Stimulation Not Applicable

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. Dizziness Handicap Inventory [ Time Frame: 10 years ]
    This is a well validated 100 point self-reported scale with Functional, Physical, and Emotional components.


Secondary Outcome Measures :
  1. 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.

  2. Hospital Anxiety and Depression Scale [ Time Frame: 10 years ]
    This is a well validated 42 point self-reported scale of anxiety and dizziness.


Other Outcome Measures:
  1. SF-12 [ Time Frame: 10 years ]
    Well-established Quality of Life Scale

  2. Motion Sickness Susceptibility Scale [ Time Frame: 10 years ]
    Measures motion sickness susceptibility before and after age 12

  3. Neo-Five Factor Inventory [ Time Frame: 10 years ]
    Quantifies the five major personality traits

  4. Empathy Quotient [ Time Frame: 10 years ]
    40-item online or 20-item abbreviated scale to determine strength of empathic traits

  5. Functional Activities Scale [ Time Frame: 10 years ]
    Measures comfort with doing some basic activities of daily living

  6. Memory Questionnaire [ Time Frame: 10 years ]
    Measures subjective impressions of prospective and retrospective memory

  7. Multidimensional Fatigue Inventory [ Time Frame: 10 years ]
    Measures general, physical, and mental fatigue

  8. Edinburgh Handedness Scale [ Time Frame: 10 years ]
    Standard measure of handedness



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 rocking dizziness triggered by passive motion such as from water, land, or air travel and with no other central nervous system or peripheral vestibular disorder determined after appropriate evaluation.

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 anywhere in the body (infusion pumps, pacemakers, metal or shrapnel in the body, deep brain stimulators, aneurysm clips, metal prostheses, joints, rods or plates). Dental fillings are acceptable.
  5. Personal history of seizures or a first-degree relative with epilepsy
  6. Medications known to lower seizure threshold such as: typical (high-potency) neuroleptics and tricyclic antidepressants: Subjects who take one or a combination of the following drugs will be excluded: imipramine, amitriptyline, doxepin, nortriptyline, maprotiline, chlorpromazine. clozapine, foscarnet, ganciclovir, ritonavir, amphetamines, cocaine (including MDMA, ecstasy), phencyclidine (PCP, angel's dust), ketamine, gamma-hydroxybutyrate (GHB), theophylline, haloperidol, fluphenazine, bupropion.
  7. Pregnancy or planning to become pregnant during study enrollment.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02470377


Locations
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United States, Minnesota
University of Minnesota
Minneapolis, Minnesota, United States, 55414
Sponsors and Collaborators
Laureate Institute for Brain Research, Inc.
Investigators
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Principal Investigator: Yoon-Hee Cha University of Minnesota
Publications:
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Responsible Party: Yoon-Hee Cha, Yoon-Hee Cha, MD, University of Minnesota
ClinicalTrials.gov Identifier: NCT02470377    
Other Study ID Numbers: 2012-003-01
First Posted: June 12, 2015    Key Record Dates
Last Update Posted: January 28, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Anonymized data may be shared with other researchers when there is sufficient recruitment to assure that no individual may be identified based on demographic or clinical characteristics.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Yoon-Hee Cha, University of Minnesota:
MdDS
TMS
fMRI
EEG
Additional relevant MeSH terms:
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Syndrome
Disease
Pathologic Processes