Transcranial Magnetic Stimulation for Mal de Debarquement Syndrome
Status: | Recruiting |
---|---|
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 3/2/2019 |
Start Date: | January 2012 |
End Date: | January 2022 |
Contact: | Diamond Urbano, BA |
Email: | mddsresearch@laureateinstitute.org |
Phone: | 918-502-5127 |
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.
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.
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.
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.
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.
We found this trial at
1
site
Tulsa, Oklahoma 74136
Principal Investigator: Yoon-Hee Cha, MD
Phone: 918-502-5126
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