- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02470377
Transcranial Magnetic Stimulation for Mal de Debarquement Syndrome
August 9, 2022 updated by: Yoon-Hee Cha, University of Minnesota
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
24
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Minnesota
-
Minneapolis, Minnesota, United States, 55414
- University of Minnesota
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Target 1: Occipital Cortex
After determination of the motor threshold, the TMS coil will be positioned over the midline occipital cortex using MRI guidance and a frameless stereotaxy system.
A train of stimulation pulses in continuous theta burst mode will be delivered.
|
A form of external neuromodulation using pulsatile magnetic fields on the surface of the head.
|
Experimental: Target 2: Cerebellar Vermis
After determination of the motor threshold, the TMS coil will be positioned over the midline cerebellar vermis using MRI guidance and a frameless stereotaxy system.
A train of stimulation pulses in continuous theta burst mode will be delivered.
|
A form of external neuromodulation using pulsatile magnetic fields on the surface of the head.
|
Active Comparator: Target 3: Cerebellar Hemisphere
After determination of the motor threshold, the TMS coil will be positioned over the lateral cerebellar hemisphere using MRI guidance and a frameless stereotaxy system.
A train of stimulation pulses in continuous theta burst mode will be delivered.
|
A form of external neuromodulation using pulsatile magnetic fields on the surface of the head.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
|
10 weeks (4 pre stimulation + 6 post stimulation)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
10 weeks (4 pre stimulation + 6 post stimulation)
|
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).
|
10 weeks (4 pre stimulation + 6 post stimulation)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Yoon-Hee Cha, University of Minnesota
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 1, 2015
Primary Completion (Actual)
July 1, 2017
Study Completion (Actual)
July 1, 2017
Study Registration Dates
First Submitted
June 9, 2015
First Submitted That Met QC Criteria
June 11, 2015
First Posted (Estimate)
June 12, 2015
Study Record Updates
Last Update Posted (Actual)
August 31, 2022
Last Update Submitted That Met QC Criteria
August 9, 2022
Last Verified
August 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2012-003-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
IPD Plan Description
Anonymized data may be shared with other researchers when there is sufficient recruitment to assure that no individual may be identified based on demographic or clinical characteristics.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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