Clinical trial NCT02470377: Transcranial Magnetic Stimulation for Mal de Debarquement Syndrome
Official title: Transcranial Magnetic Stimulation for Mal de Debarquement Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mal de Debarquement Syndrome
Keywords: MdDS
TMS
fMRI
EEG
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2015-06-12
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
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.
Primary purpose: TREATMENT

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.

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.

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.

Primary outcomes:
measure: Dizziness Handicap Inventory
timeFrame: 10 weeks (4 pre stimulation + 6 post stimulation)
Secondary outcomes:
measure: Mal de Debarquement Balance Rating Scale
timeFrame: 10 weeks (4 pre stimulation + 6 post stimulation)
measure: Hospital Anxiety and Depression Scale
timeFrame: 10 weeks (4 pre stimulation + 6 post stimulation)
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Yoon-Hee Cha
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cha YH, Ding L, Yuan H. Neuroimaging Markers of Mal de Debarquement Syndrome. Front Neurol. 2021 Mar 4;12:636224. doi: 10.3389/fneur.2021.636224. eCollection 2021.
citation: Cha YH, Gleghorn D, Doudican B. Occipital and Cerebellar Theta Burst Stimulation for Mal De Debarquement Syndrome. Otol Neurotol. 2019 Oct;40(9):e928-e937. doi: 10.1097/MAO.0000000000002341.
citation: Chen Y, Cha YH, Gleghorn D, Doudican BC, Shou G, Ding L, Yuan H. Brain network effects by continuous theta burst stimulation in mal de debarquement syndrome: simultaneous EEG and fMRI study. J Neural Eng. 2021 Nov 30;18(6):10.1088/1741-2552/ac314b. doi: 10.1088/1741-2552/ac314b.