N/A
N=24
Transcranial Magnetic Stimulation for Mal de Debarquement Syndrome
Mal de Debarquement Syndrome
Bottom Line
View on ClinicalTrials.gov: NCT02470377 ↗Enrolled (actual)
24
Serious AEs
0.0%
Results posted
Aug 2022
Primary outcome: Primary: Dizziness Handicap Inventory — -17.5; -3.7; -8.4; -10.1 score on a scale — p=0.0439
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Transcranial Magnetic Stimulation (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Minnesota
- Primary completion
- Jul 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Dizziness Handicap Inventory |
-17.5; -3.7; -8.4; -10.1; -9.7; -4.0 | 0.0439 sig |
| SECONDARY Mal de Debarquement Balance Rating Scale |
-1.8; -1.3; -0.1; -1.1; -1.3; -0.1 | 0.0316 sig |
| SECONDARY Hospital Anxiety and Depression Scale |
-2.5; 0.8; -0.2; -2.2; -1.6; -0.4 | 0.1754 |
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.
Eligibility Criteria
Inclusion criteria
- Age ≥18 years old
- Willing and capable of interacting with the informed consent process
- 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
- Subjects who cannot comply with study conditions.
- Active psychiatric condition such as mania or psychosis
- Unstable medical condition
- 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.
- Personal history of seizures or a first-degree relative with epilepsy
- 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.
- Pregnancy or planning to become pregnant during study enrollment.
Data sourced from ClinicalTrials.gov (NCT02470377). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.