Transcranial Magnetic Stimulation for Mal de Debarquement Syndrome

Mal de Debarquement Syndrome Clinical Trial

Official title:

Transcranial Magnetic Stimulation for Mal de Debarquement Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02470377
• Other study ID #: 2012-003-01
• Status: Completed
• Phase: N/A
• Start date: August 2015
• Est. completion date: July 2017

Study information

• Verified date: August 2022
• Source: University of Minnesota
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: July 2017
• Est. primary completion date: July 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Mal de Debarquement Syndrome
• Syndrome

Intervention

Device:
• Transcranial Magnetic Stimulation
A form of external neuromodulation using pulsatile magnetic fields on the surface of the head.

Locations

Country	Name	City	State
United States	University of Minnesota	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
University of Minnesota

Country where clinical trial is conducted

United States, 

References & Publications (3)

Cha YH, Ding L, Yuan H. Neuroimaging Markers of Mal de Débarquement Syndrome. Front Neurol. 2021 Mar 4;12:636224. doi: 10.3389/fneur.2021.636224. eCollection 2021. Review. — View 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. — View 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 débarquement syndrome: simultaneous EEG and fMRI study. J Neural Eng. 2021 Nov 30;18(6). doi: 10.1088/1741-2552/ac314b. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dizziness Handicap Inventory	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).	10 weeks (4 pre stimulation + 6 post stimulation)
Secondary	Mal de Debarquement Balance Rating Scale	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.	10 weeks (4 pre stimulation + 6 post stimulation)
Secondary	Hospital Anxiety and Depression Scale	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).	10 weeks (4 pre stimulation + 6 post stimulation)