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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 : Completed
First Posted : June 12, 2015
Results First Posted : August 31, 2022
Last Update Posted : August 31, 2022
Sponsor:
Information provided by (Responsible Party):
Yoon-Hee Cha, University of Minnesota

Study Description
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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.

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. Post treatment diaries will continue for up to 12 weeks after rTMS administration.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Intervention Model Description: This was an N-of-1 pilot study in which all participants received one session of each of 3 targets and chose which of the 3 led to the most acute reduction in intensity of rocking. The participants were treated with the target that they chose and then completed post stimulation diaries.
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Transcranial Magnetic Stimulation for Mal de Debarquement Syndrome
Actual Study Start Date : August 2015
Actual Primary Completion Date : July 2017
Actual Study Completion Date : July 2017

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Target 1: Occipital Cortex
After determination of the motor threshold, the TMS coil will be positioned over the midline occipital cortex using MRI guidance and a frameless stereotaxy system. A train of stimulation pulses in continuous theta burst mode will be delivered.
 Device: Transcranial Magnetic Stimulation
A form of external neuromodulation using pulsatile magnetic fields on the surface of the head.
Experimental: Target 2: Cerebellar Vermis
After determination of the motor threshold, the TMS coil will be positioned over the midline cerebellar vermis using MRI guidance and a frameless stereotaxy system. A train of stimulation pulses in continuous theta burst mode will be delivered.
 Device: Transcranial Magnetic Stimulation
A form of external neuromodulation using pulsatile magnetic fields on the surface of the head.
Active Comparator: Target 3: Cerebellar Hemisphere
After determination of the motor threshold, the TMS coil will be positioned over the lateral cerebellar hemisphere using MRI guidance and a frameless stereotaxy system. A train of stimulation pulses in continuous theta burst mode will be delivered.
 Device: Transcranial Magnetic Stimulation
A form of external neuromodulation using pulsatile magnetic fields on the surface of the head.


Outcome Measures
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Primary Outcome Measures :
  1. Dizziness Handicap Inventory [ Time Frame: 10 weeks (4 pre stimulation + 6 post stimulation) ]
    The Dizziness Handicap Inventory is a widely used measure of subjective dizziness in which 25 questions of dizziness inducing events are rated on a scale of 0-2-4. The maximum number of points is 100 points which are divided into the following levels: 16-34 Points (mild handicap), 36-52 Points (moderate handicap), 54+ Points (severe handicap).


Secondary Outcome Measures :
  1. Mal de Debarquement Balance Rating Scale [ Time Frame: 10 weeks (4 pre stimulation + 6 post stimulation) ]
    The MdDS Balance Rating Scale is a 10-point scale inquiring about the severity of rocking vertigo in which 1 means no rocking and 10 is so severe that standing is not possible. A level of 6 indicates that gait is impaired due to the severity of rocking.

  2. Hospital Anxiety and Depression Scale [ Time Frame: 10 weeks (4 pre stimulation + 6 post stimulation) ]
    The Hospital Anxiety and Depression Scale is a widely used scale that inquires about anxiety and depression symptoms with 14 questions divided into 7 questions about anxiety and 7 questions about depression. Each item is rated from 0-3 per item yielding a maximum of 21 points per item. Each subscale is rated as follows: 0-7 (Normal), 8-10 (Borderline), 11-21 (Abnormal).


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (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.
Contacts and Locations
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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
University of Minnesota
Investigators
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Principal Investigator: Yoon-Hee Cha University of Minnesota
  Study Documents (Full-Text)

Documents provided by Yoon-Hee Cha, University of Minnesota:
Study Protocol and Statistical Analysis Plan  [PDF] July 28, 2015

More Information
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Publications of Results:

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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
Results First Posted: August 31, 2022
Last Update Posted: August 31, 2022
Last Verified: August 2022
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