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Completed

NCT Number: NCT02470377

Transcranial Magnetic Stimulation for Mal de Debarquement Syndrome

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.

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Key information

Conditions

Mal de Debarquement Syndrome Mal de debarquement

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Minnesota

Minneapolis, Minnesota, 55414, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Transcranial Magnetic Stimulation

Device

A form of external neuromodulation using pulsatile magnetic fields on the surface of the head.

Primary outcomes

  1. Dizziness Handicap Inventory

    Time frame: 10 weeks (4 pre stimulation + 6 post stimulation)

    The Dizziness Handicap Inventory is a widely used measure of subjective dizziness in which 25 questions of dizziness inducing events are rated on a scale of 0-2-4. The maximum number of points is 100 points which are divided into the following levels: 16-34 Points (mild handicap), 36-52 Points (moderate handicap), 54+ Points (severe handicap).

Secondary outcomes

  1. Mal de Debarquement Balance Rating Scale

    Time frame: 10 weeks (4 pre stimulation + 6 post stimulation)

    The MdDS Balance Rating Scale is a 10-point scale inquiring about the severity of rocking vertigo in which 1 means no rocking and 10 is so severe that standing is not possible. A level of 6 indicates that gait is impaired due to the severity of rocking.

  2. Hospital Anxiety and Depression Scale

    Time frame: 10 weeks (4 pre stimulation + 6 post stimulation)

    The Hospital Anxiety and Depression Scale is a widely used scale that inquires about anxiety and depression symptoms with 14 questions divided into 7 questions about anxiety and 7 questions about depression. Each item is rated from 0-3 per item yielding a maximum of 21 points per item. Each subscale is rated as follows: 0-7 (Normal), 8-10 (Borderline), 11-21 (Abnormal).

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Registry information

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Jun 12, 2015
Registry last updated
Aug 31, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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