Mal de Debarquement SyndromeNCT02470377
Transcranial Magnetic Stimulation for Mal de Debarquement Syndrome
A study testing Transcranial Magnetic Stimulation in people with Mal de Debarquement Syndrome, run by University of Minnesota at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Mal de Debarquement Syndrome
- What is being tested?
- Transcranial Magnetic Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2015to Jul 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota
Minneapolis, Minnesota, 55414
About this study
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.
Read the 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.
- Conditions
- Mal de Debarquement Syndrome
- Being tested
- Transcranial Magnetic Stimulation
- Keywords
- MdDS, TMS, fMRI, EEG
- Medical subject headings
- Mal de debarquement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial Magnetic StimulationDevice
A form of external neuromodulation using pulsatile magnetic fields on the surface of the head.
| Study group | Role | What they receive |
|---|---|---|
| Target 1: Occipital Cortex | Experimental | 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. Receives: Device: Transcranial Magnetic Stimulation |
| Target 2: Cerebellar Vermis | Experimental | 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. Receives: Device: Transcranial Magnetic Stimulation |
| Target 3: Cerebellar Hemisphere | Active comparator | 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. Receives: Device: Transcranial Magnetic Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 10 weeks (4 pre stimulation + 6 post stimulation)
Secondary outcomes (2)
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.
Measured: 10 weeks (4 pre stimulation + 6 post stimulation)
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).
Measured: 10 weeks (4 pre stimulation + 6 post stimulation)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2015 (estimated)
- Study startAug 2015
- Primary completionJul 2017
- Study completionJul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Mal de Debarquement SyndromeStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yoon-Hee Cha, University of Minnesota
- Investigators
- Yoon-Hee Cha, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02470377
- Sponsor's protocol ID
- 2012-003-01
- Status last verified
- Aug 2022
- First submitted
- 9 Jun 2015
- Last updated
- 31 Aug 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: 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.
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.
PubMed 33746890Cha 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.
PubMed 31436631Chen 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.
PubMed 34670201
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcranial Magnetic Stimulation for Mal de Debarquement Syndrome
- ClinicalTrials.gov ID
- NCT02470377
- Acronym / sponsor ID
- 2012-003-01
- Conditions
- Mal de Debarquement Syndrome
- Keywords
- MdDS, TMS, fMRI, EEG
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- Aug 2015 (actual)
- Primary completion
- Jul 2017 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 12 Jun 2015 (estimated)
- Results
- Posted 31 Aug 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| Target 1: Occipital Cortex | Experimental | Device: Transcranial Magnetic StimulationAfter 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. |
| Target 2: Cerebellar Vermis | Experimental | Device: Transcranial Magnetic StimulationAfter 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. |
| Target 3: Cerebellar Hemisphere | Active comparator | Device: Transcranial Magnetic StimulationAfter 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcranial Magnetic StimulationA form of external neuromodulation using pulsatile magnetic fields on the surface of the head. | Device | Target 1: Occipital Cortex, Target 2: Cerebellar Vermis, Target 3: Cerebellar Hemisphere |
Primary outcome
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).
2 secondary outcomes
Mal de Debarquement Balance Rating Scale
Time frame: 10 weeks (4 pre stimulation + 6 post stimulation)
Hospital Anxiety and Depression Scale
Time frame: 10 weeks (4 pre stimulation + 6 post stimulation)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 33746890Cha 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.
- Results publication: PubMed 31436631Cha 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.
- Results publication: PubMed 34670201Chen 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.
- Individual participant dataSharing planned: No. 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yoon-Hee Cha principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial Magnetic Stimulation in people with Mal de Debarquement Syndrome, run by University of Minnesota at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 Aug 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dizziness Handicap Inventory (time frame: 10 weeks (4 pre stimulation + 6 post stimulation)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02470377, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2022.