Mal de Debarquement SyndromeNCT02540616
Transcranial Electrical Stimulation for Mal de Debarquement Syndrome
A study testing Transcranial Electrical 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 transcranial electrical stimulation (TES) can reduce the perception of self-motion that is experienced by patients with MdDS. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mal de Debarquement Syndrome
- What is being tested?
- Transcranial Electrical Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2013to Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- 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 perception of motion with no other cause determined after a careful interview.
- Able to identity a study buddy and provide contact information
Who cannot join
- Subjects who cannot comply with study conditions.
- Active psychiatric condition such as mania or psychosis
- Unstable medical condition
- Implanted metal in the head or neck (metal or shrapnel, deep brain stimulators, aneurysm clips, cochlear stimulators, retinal implants, etc). Dental fillings are acceptable.
- Any active skin disorder that affects skin integrity of the scalp.
- Pregnant
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 transcranial electrical stimulation (TES) can reduce the perception of self-motion that is experienced by patients with 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. A similar form of rocking dizziness can be experienced without a motion trigger in individuals with certain risk factors.
Treatment for MdDS is limited and morbidity is high.The goal of the study is to determine whether TES can suppress the rocking dizziness of MdDS either as a standalone therapy or as an adjunctive therapy to other forms of neuromodulation such as transcranial magnetic stimulation. The investigators will determine the optimal treatment duration and stimulation parameters.
Read the detailed description
Eligible participants who meet study criteria and pass the safety screen will be invited to participate in the study. If TES is used as add-on treatment to repetitive transcranial magnetic stimulation (rTMS), the training for TES application will be done on-site. However, in a portion of the study that does not involve rTMS, remote training will be performed via a webcam provided that a suitable "Study Buddy" is available to assist the participant.
Participants will maintain web-based diaries of their symptoms for up to four weeks prior to treatment with TES. Before the actual treatment sessions are started, the subjects will complete baseline questionnaires online which will be repeated once a week for up to 12 weeks. Over the course of the study, the subjects will also keep a daily log of their sessions such as how many sessions they performed, for how long, and whether they had any side effects with each session.
The studies will include a sham arm, allocated at a ratio of 1:1. On-site studies will involve the application of EEG, MRI, balance, cognitive, and visual/auditory stimulation tests.
- Conditions
- Mal de Debarquement Syndrome
- Being tested
- Transcranial Electrical Stimulation
- Keywords
- MdDS, TES, TMS
- 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 Electrical StimulationDevice
Also called Transcranial Direct Current Stimulation (tDCS), Transcranial Alternating Current Stimulation (tACS), Transcranial Random Noise Stimulation (tRNS), Sham Transcranial Stimulation
A form of external neuromodulation using electrodes on the surface of the head. We will be using the TCT tDCS device (www.trans.cranial.com) or devices constructed by our research group or collaborators.
| Study group | Role | What they receive |
|---|---|---|
| Transcranial Electrical Stimulation-Real | Experimental | The participant will perform real TES. The forms of TES used in this study will include transcranial direct current stimulation (tDCS), transcranial alternating current stimulation (tACS), or transcranial random noise stimulation (tRNS). Each stimulation session will last for 20-minutes. Receives: Device: Transcranial Electrical Stimulation |
| Transcranial Electrical Stimulation-Sham | Sham comparator | The participant will perform sham TES for 20-minutes. The form of sham TES will depend on the active arm, e.g. if tACS is on the active arm, then the sham tACS will be a different frequency of stimulation. If tDCS is the active arm, then a short ramp up of tDCS followed by a ramp down (about 60-seconds) will be used as the sham arm. Receives: Device: Transcranial Electrical Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dizziness Handicap Inventory
This is a well validated 100 point self-reported scale with Functional, Physical, and Emotional components.
Measured: 10 years
Secondary outcomes (2)
Mal de Debarquement Balance Rating Scale
This is a 10 point self-reported scale that assesses the severity of rocking dizziness and its effect on balance function.
Measured: 10 years
Hospital Anxiety and Depression Scale
This is a well validated 42 point self-reported scale of anxiety and dizziness.
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2015 (estimated)
- Study startSep 2013
- Primary completionDec 2022 (estimated)
- Study completionDec 2022 (estimated)
Why it stopped: Study hypothesis was faulty
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Randomised
- Intervention model
- Crossover
- Model description
- Participants will be randomized to a real vs a sham stimulation arm. The sham arm will be offered real treatment after unblinding.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yoon-Hee Cha, MD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02540616
- Sponsor's protocol ID
- 2013-006-01
- Status last verified
- Mar 2023
- First submitted
- 2 Sep 2015
- Last updated
- 16 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: Anonymized data will be shared once recruitment is sufficient to prevent the inadvertent identification of participants by demographic or clinical characteristics
Publications
Cha YH, Gleghorn D, Doudican BC. Double-blind randomized N-of-1 trial of transcranial alternating current stimulation for mal de debarquement syndrome. PLoS One. 2022 Feb 4;17(2):e0263558. doi: 10.1371/journal.pone.0263558. eCollection 2022.
PubMed 35120184
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcranial Electrical Stimulation for Mal de Debarquement Syndrome
- ClinicalTrials.gov ID
- NCT02540616
- Acronym / sponsor ID
- 2013-006-01
- Conditions
- Mal de Debarquement Syndrome
- Keywords
- MdDS, TES, TMS
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study hypothesis was faulty
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 4 Sep 2015 (estimated)
- Results
- Not posted in the source record
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 transcranial electrical stimulation (TES) can reduce the perception of self-motion that is experienced by patients with 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. A similar form of rocking dizziness can be experienced without a motion trigger in individuals with certain risk factors.
Treatment for MdDS is limited and morbidity is high.The goal of the study is to determine whether TES can suppress the rocking dizziness of MdDS either as a standalone therapy or as an adjunctive therapy to other forms of neuromodulation such as transcranial magnetic stimulation. The investigators will determine the optimal treatment duration and stimulation parameters.
Detailed description
Eligible participants who meet study criteria and pass the safety screen will be invited to participate in the study. If TES is used as add-on treatment to repetitive transcranial magnetic stimulation (rTMS), the training for TES application will be done on-site. However, in a portion of the study that does not involve rTMS, remote training will be performed via a webcam provided that a suitable "Study Buddy" is available to assist the participant.
Participants will maintain web-based diaries of their symptoms for up to four weeks prior to treatment with TES. Before the actual treatment sessions are started, the subjects will complete baseline questionnaires online which will be repeated once a week for up to 12 weeks. Over the course of the study, the subjects will also keep a daily log of their sessions such as how many sessions they performed, for how long, and whether they had any side effects with each session.
The studies will include a sham arm, allocated at a ratio of 1:1. On-site studies will involve the application of EEG, MRI, balance, cognitive, and visual/auditory stimulation tests.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Participants will be randomized to a real vs a sham stimulation arm. The sham arm will be offered real treatment after unblinding.
| Arm | Type | Receives |
|---|---|---|
| Transcranial Electrical Stimulation-Real | Experimental | Device: Transcranial Electrical StimulationThe participant will perform real TES. The forms of TES used in this study will include transcranial direct current stimulation (tDCS), transcranial alternating current stimulation (tACS), or transcranial random noise stimulation (tRNS). Each stimulation session will last for 20-minutes. |
| Transcranial Electrical Stimulation-Sham | Sham comparator | Device: Transcranial Electrical StimulationThe participant will perform sham TES for 20-minutes. The form of sham TES will depend on the active arm, e.g. if tACS is on the active arm, then the sham tACS will be a different frequency of stimulation. If tDCS is the active arm, then a short ramp up of tDCS followed by a ramp down (about 60-seconds) will be used as the sham arm. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥18 years old
- Willing and capable of interacting with the informed consent process
- Primary disorder being a persistent perception of motion with no other cause determined after a careful interview.
- Able to identity a study buddy and provide contact information
Key exclusion criteria (6 listed)
- Subjects who cannot comply with study conditions.
- Active psychiatric condition such as mania or psychosis
- Unstable medical condition
- Implanted metal in the head or neck (metal or shrapnel, deep brain stimulators, aneurysm clips, cochlear stimulators, retinal implants, etc). Dental fillings are acceptable.
- Any active skin disorder that affects skin integrity of the scalp.
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 Electrical StimulationAlso: Transcranial Direct Current Stimulation (tDCS), Transcranial Alternating Current Stimulation (tACS), Transcranial Random Noise Stimulation (tRNS), Sham Transcranial StimulationA form of external neuromodulation using electrodes on the surface of the head. We will be using the TCT tDCS device (www.trans.cranial.com) or devices constructed by our research group or collaborators. | Device | Transcranial Electrical Stimulation-Real, Transcranial Electrical Stimulation-Sham |
Primary outcome
Dizziness Handicap Inventory
Time frame: 10 years
This is a well validated 100 point self-reported scale with Functional, Physical, and Emotional components.
2 secondary outcomes
Mal de Debarquement Balance Rating Scale
Time frame: 10 years
Hospital Anxiety and Depression Scale
Time frame: 10 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2023.
- Derived from this study: PubMed 35120184Cha YH, Gleghorn D, Doudican BC. Double-blind randomized N-of-1 trial of transcranial alternating current stimulation for mal de debarquement syndrome. PLoS One. 2022 Feb 4;17(2):e0263558. doi: 10.1371/journal.pone.0263558. eCollection 2022.
- Individual participant dataSharing planned: No. Anonymized data will be shared once recruitment is sufficient to prevent the inadvertent identification of participants by 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, MD 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 Electrical 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 4 inclusion and 6 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: withdrawn, as of the sponsor's last update on 16 Mar 2023. 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. Some participants in this study may receive a placebo. 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?
The study was withdrawn before enrolling participants, so there are no results.
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 years). 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 NCT02540616, which also lists 1 linked publication.
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 16 Mar 2023.