Tulsa, Oklahoma 74136


Purpose:

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.


Study 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.


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.


NCT ID:

NCT02470377


Primary Contact:

Principal Investigator
Yoon-Hee Cha, MD
Laureate Institute for Brain Resarch

Diamond Urbano, BA
Phone: 918-502-5127
Email: mddsresearch@laureateinstitute.org


Backup Contact:

Email: ycha@laureateinstitute.org
Yoon-Hee Cha, MD
Phone: 918-502-5122


Location Contact:

Tulsa, Oklahoma 74136
United States

Diamond Urbano, BA
Phone: 918-502-5126
Email: mddsresearch@laureateinstitute.org

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: November 21, 2017

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