Transcranial Magnetic Stimulation for Mal de Debarquement Syndrome

Brief Title

Transcranial Magnetic Stimulation for Mal de Debarquement Syndrome

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 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.
    


Study Type

Interventional


Primary Outcome

Dizziness Handicap Inventory

Secondary Outcome

 Mal de Debarquement Balance Rating Scale

Condition

Mal de Debarquement Syndrome

Intervention

Transcranial Magnetic Stimulation

Study Arms / Comparison Groups

 Transcranial Magnetic Stimulation
Description:  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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Device

Estimated Enrollment

300

Start Date

January 2012

Completion Date

January 2022

Primary Completion Date

January 2022

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 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.
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Yoon-Hee Cha, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT02470377

Organization ID

2012-003-01


Responsible Party

Principal Investigator

Study Sponsor

Laureate Institute for Brain Research, Inc.


Study Sponsor

Yoon-Hee Cha, Principal Investigator, University of Minnesota


Verification Date

January 2020