Mal de Debarquement Syndrome (MdDS)NCT07304414
Optokinetic Stimulation in Mal de Debarquement Syndrome: Case Report
A study testing Optokinetic stimulation in people with Mal de Debarquement Syndrome (MdDS), run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).
Trial summary
This single-case study aims to evaluate the clinical effects of optokinetic stimulation (OKS) on dizziness perception and quality of life in a patient diagnosed with Mal de Débarquement Syndrome (MdDS). Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Mal de Debarquement Syndrome (MdDS)
- What is being tested?
- Optokinetic stimulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 24 Oct 2025to 30 Nov 2025
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Subjective perception of movement in the "rocking/bobbing/swaying" type, beginning after exposure to passive motion (sea/aircraft/vehicle, etc.),
- lasting ≥1 month,
- Temporary relief of symptoms upon re-exposure to passive motion,
- Findings not better explained by an alternative diagnosis.
- Head and neck health must be at a level that allows head roll movement during optokinetic stimulation (no serious cervical limitation).
Who cannot join
- Alternative vestibular/otologic diagnoses: active BPPV, Meniere's disease, acute vestibular neuronitis, significant peripheral vestibulopathy; or significant central cause (stroke, CNS lesion, etc.).
- History of photosensitizer epilepsy or uncontrolled epilepsy
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Medipol University
Istanbul, Beykoz, 34810
About this study
Official title: Clinical Improvement Following Optokinetic Stimulation in Mal de Débarquement Syndrome: A Case Study
This single-case study aims to evaluate the clinical effects of optokinetic stimulation (OKS) on dizziness perception and quality of life in a patient diagnosed with Mal de Débarquement Syndrome (MdDS). The intervention follows a standardized protocol in which the patient performs head roll movements synchronized with optokinetic visual stimulation at a frequency of 0.167 Hz (10 bpm). The study is conducted online using a digital application to provide full-field optokinetic stimulation. The patient's baseline motion sickness susceptibility was characterized using the Motion Sickness Susceptibility Questionnaire-Short Form (MSSQ-SF). Primary outcome measures assessed for change from baseline include the Dizziness Handicap Inventory (DHI), Visual Analog Scale (VAS), and the Istanbul MdDS Scale
Read the detailed description
Mal de Débarquement Syndrome (MdDS) is a rare neuro-otological disorder characterized by a persistent perception of self-motion, typically described as rocking, swaying, or bobbing sensations, following exposure to passive motion such as sea, air, or land travel. The syndrome can significantly impair balance, spatial orientation, and quality of life. Conventional therapeutic approaches are limited, and symptoms may persist for weeks, months, or even years. Recent studies have suggested that maladaptation of the vestibulo-ocular reflex (VOR) and velocity storage mechanisms may play a central role in the pathophysiology of MdDS.
In this single-case study, a 28-year-old female patient with a clinical diagnosis of MdDS will undergo an online OKS-based rehabilitation program. The intervention will be conducted remotely via the Smart Optometry application, using the "OKN Stripes" module to deliver full-field optokinetic visual stimulation. The participant will sit close to the screen, ensuring that the optokinetic stripes occupy approximately 85-90% of the visual field. The researcher will guide each session online, ensuring the synchronization of head roll movements with the visual stimuli using a metronome (10 bpm). The intervention will be implemented for 3-5 consecutive days, with two sessions in the morning and two in the afternoon, each lasting 4 minutes.
Assessment and Follow-up: Clinical outcomes are evaluated at multiple time points to monitor the progression and long-term sustainability of the treatment:
Baseline (T0): Pre-treatment assessment. Post-treatment (T1): Immediately following the 5-day protocol. Short-term Follow-up (T2): 1 month after treatment. Long-term Follow-up (T3): 1 year after treatment to evaluate the durability of neuroplastic changes.
Primary metrics include the Dizziness Handicap Inventory (DHI) for perceived disability, the Visual Analog Scale (VAS) for dizziness intensity, and the Istanbul MdDS Scale for syndrome-specific symptoms. To determine the patient's clinical profile and support differential diagnosis, the Motion Sickness Susceptibility Questionnaire - Short Form (MSSQ-SF) will be administered initially.
This study aims to contribute to the limited clinical evidence on non-invasive, visual-vestibular rehabilitation strategies for MdDS and to explore the feasibility of delivering optokinetic therapy in an online, remote setting.
- Conditions
- Mal de Debarquement Syndrome (MdDS)
- Being tested
- Optokinetic stimulation
- Keywords
- mal de debarquement syndrome, optokinetic stimulation, dizziness, postural balance, quality of life, vestibular disorders
- Medical subject headings
- Mal de debarquement, Dizziness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Optokinetic stimulationOther
The planned optokinetic stimulation (OKS) application will be implemented. The application will last for 5 consecutive days, with a total of 4 sessions, two in the morning and two in the afternoon. Each session will last 5 minutes, and head turns will be synchronized with a metronome at 10 beats per minute (10 bpm). Each beat will complete a full right-left cycle, achieving a frequency of approximately 0.167 Hz. This arrangement reflects the standardized protocol recommended in the literature.
The application will be conducted online, and the participant will use the "Optokinetic nystagmus (OKN) lines" section within the "Smart Optometry" application on their computer. The direction of the lines will move in the direction opposite the patient's dominantly affected side. The participant was seated close to the screen, and approximately 85-90% of their visual field covered by the moving stimuli.
| Study group | Role | What they receive |
|---|---|---|
| Optokinetic stimulation (OKS) Intervention | Experimental | The participant will receive optokinetic stimulation. The intervention consists of full-field visual stimulation with horizontally moving stripes synchronized with slow head roll movements at a frequency of 0.167 Hz (10 bpm). Sessions will be performed online via the Smart Optometry application, twice daily for 5 consecutive days, with each session lasting approximately 4 minutes. The goal of the intervention is to recalibrate vestibulo-ocular reflex activity and reduce dizziness and imbalance symptoms associated with Mal de Débarquement Syndrome. Receives: Other: Optokinetic stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Level of Disability
Dizziness Handicap Inventory: Provides information about disability and quality of life in individuals with vestibular disorders. The scale assesses the functional, physical, and emotional effects of dizziness on disability over the past month. It consists of 25 questions, 9 functional, 7 physical, and 9 emotional, with three answer options: yes (4 points), sometimes (2 points), and no (0 points). A total score is calculated along with the scores for each subsection. The total score ranges from 0 to 100, with higher scores indicating greater disability. According to the total score, the level of disability is classified as follows: 16-34 points as mild; 36-52 points as moderate; and 54 and above as severe. This scale, whose
Measured: From enrollment (baseline) until the final follow-up, assessed at multiple time points: baseline, immediately post-treatment (day 5), 1 month, and 1 year.
Istanbul Mal de Debarquement Scale
The scale is composed of subfactors to better assess MdDS. The scale consists of four subfactors: "Diagnostic Criteria" (items 1-5), "Dizziness Character" (items 6-9), "Visual Movement Intolerance" (items 10-12), and "Quality of Life" (items 13-18). The scale was designed using a 5-point Likert-type scale, using the terms "Always," "Frequently," "Sometimes," "Rarely," and "Never." These statements were scored from 5 to 1, respectively. The total scale score was calculated as 100. Permission was obtained from the scale's author for use.
Measured: From enrollment (baseline) until the final follow-up, assessed at multiple time points: baseline, immediately post-treatment (day 5), 1 month, and 1 year.
Dizziness Severity
Visual Analog Scale: The participant's dizziness intensity was assessed on a scale between 0 and 10-cm line, where 0 represents "no vertigo/dizziness," and 10 represents "extreme dizziness. Scores are categorized as mild (2-3), moderate (4-5), severe (6-7), quite severe (8-9), and extreme.
Measured: From enrollment (baseline) until the final follow-up, assessed at multiple time points: baseline, immediately post-treatment (day 5), 1 month, and 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2025
- Study start24 Oct 2025
- Primary completion29 Oct 2025
- Study completion30 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mal de Debarquement Syndrome (MdDS)Studies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Medipol University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, gorkem ata, Istanbul Medipol University Hospital
- Investigators
- Görkem ATA, Ph.D., Principal investigator, Medipol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07304414
- Sponsor's protocol ID
- E-10840098-202.3.02-6657
- Status last verified
- Dec 2025
- First submitted
- 8 Dec 2025
- Last updated
- 26 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared because this is a single-patient case study. Sharing de-identified data could risk patient confidentiality. Summary-level data may be reported in future publications.
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Improvement Following Optokinetic Stimulation in Mal de Débarquement Syndrome: A Case Study
- ClinicalTrials.gov ID
- NCT07304414
- Acronym / sponsor ID
- E-10840098-202.3.02-6657
- Conditions
- Mal de Debarquement Syndrome (MdDS)
- Keywords
- mal de debarquement syndrome, optokinetic stimulation, dizziness, postural balance, quality of life, vestibular disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Istanbul Medipol University HospitalUniversity, hospital or other
- Study start
- 24 Oct 2025 (actual)
- Primary completion
- 29 Oct 2025 (actual)
- Study completion
- 30 Nov 2025 (actual)
- First posted
- 26 Dec 2025 (actual)
- 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.
This single-case study aims to evaluate the clinical effects of optokinetic stimulation (OKS) on dizziness perception and quality of life in a patient diagnosed with Mal de Débarquement Syndrome (MdDS). The intervention follows a standardized protocol in which the patient performs head roll movements synchronized with optokinetic visual stimulation at a frequency of 0.167 Hz (10 bpm). The study is conducted online using a digital application to provide full-field optokinetic stimulation. The patient's baseline motion sickness susceptibility was characterized using the Motion Sickness Susceptibility Questionnaire-Short Form (MSSQ-SF). Primary outcome measures assessed for change from baseline include the Dizziness Handicap Inventory (DHI), Visual Analog Scale (VAS), and the Istanbul MdDS Scale
Detailed description
Mal de Débarquement Syndrome (MdDS) is a rare neuro-otological disorder characterized by a persistent perception of self-motion, typically described as rocking, swaying, or bobbing sensations, following exposure to passive motion such as sea, air, or land travel. The syndrome can significantly impair balance, spatial orientation, and quality of life. Conventional therapeutic approaches are limited, and symptoms may persist for weeks, months, or even years. Recent studies have suggested that maladaptation of the vestibulo-ocular reflex (VOR) and velocity storage mechanisms may play a central role in the pathophysiology of MdDS.
In this single-case study, a 28-year-old female patient with a clinical diagnosis of MdDS will undergo an online OKS-based rehabilitation program. The intervention will be conducted remotely via the Smart Optometry application, using the "OKN Stripes" module to deliver full-field optokinetic visual stimulation. The participant will sit close to the screen, ensuring that the optokinetic stripes occupy approximately 85-90% of the visual field. The researcher will guide each session online, ensuring the synchronization of head roll movements with the visual stimuli using a metronome (10 bpm). The intervention will be implemented for 3-5 consecutive days, with two sessions in the morning and two in the afternoon, each lasting 4 minutes.
Assessment and Follow-up: Clinical outcomes are evaluated at multiple time points to monitor the progression and long-term sustainability of the treatment:
Baseline (T0): Pre-treatment assessment. Post-treatment (T1): Immediately following the 5-day protocol. Short-term Follow-up (T2): 1 month after treatment. Long-term Follow-up (T3): 1 year after treatment to evaluate the durability of neuroplastic changes.
Primary metrics include the Dizziness Handicap Inventory (DHI) for perceived disability, the Visual Analog Scale (VAS) for dizziness intensity, and the Istanbul MdDS Scale for syndrome-specific symptoms. To determine the patient's clinical profile and support differential diagnosis, the Motion Sickness Susceptibility Questionnaire - Short Form (MSSQ-SF) will be administered initially.
This study aims to contribute to the limited clinical evidence on non-invasive, visual-vestibular rehabilitation strategies for MdDS and to explore the feasibility of delivering optokinetic therapy in an online, remote setting.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Optokinetic stimulation (OKS) Intervention | Experimental | Other: Optokinetic stimulationThe participant will receive optokinetic stimulation. The intervention consists of full-field visual stimulation with horizontally moving stripes synchronized with slow head roll movements at a frequency of 0.167 Hz (10 bpm). Sessions will be performed online via the Smart Optometry application, twice daily for 5 consecutive days, with each session lasting approximately 4 minutes. The goal of the intervention is to recalibrate vestibulo-ocular reflex activity and reduce dizziness and imbalance symptoms associated with Mal de Débarquement Syndrome. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Subjective perception of movement in the "rocking/bobbing/swaying" type, beginning after exposure to passive motion (sea/aircraft/vehicle, etc.),
- lasting ≥1 month,
- Temporary relief of symptoms upon re-exposure to passive motion,
- Findings not better explained by an alternative diagnosis.
- Head and neck health must be at a level that allows head roll movement during optokinetic stimulation (no serious cervical limitation).
Key exclusion criteria (2 listed)
- Alternative vestibular/otologic diagnoses: active BPPV, Meniere's disease, acute vestibular neuronitis, significant peripheral vestibulopathy; or significant central cause (stroke, CNS lesion, etc.).
- History of photosensitizer epilepsy or uncontrolled 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 |
|---|---|---|
| Optokinetic stimulationThe planned optokinetic stimulation (OKS) application will be implemented. The application will last for 5 consecutive days, with a total of 4 sessions, two in the morning and two in the afternoon. Each session will last 5 minutes, and head turns will be synchronized with a metronome at 10 beats per minute (10 bpm). Each beat will complete a full right-left cycle, achieving a frequency of approximately 0.167 Hz. This arrangement reflects the standardized protocol recommended in the literature. The application will be conducted online, and the participant will use the "Optokinetic nystagmus (OKN) lines" section within the "Smart Optometry" application on their computer. The direction of the lines will move in the direction opposite the patient's dominantly affected side. The participant was seated close to the screen, and approximately 85-90% of their visual field covered by the moving stimuli. | Other | Optokinetic stimulation (OKS) Intervention |
Primary outcome
Level of Disability
Time frame: From enrollment (baseline) until the final follow-up, assessed at multiple time points: baseline, immediately post-treatment (day 5), 1 month, and 1 year.
Dizziness Handicap Inventory: Provides information about disability and quality of life in individuals with vestibular disorders. The scale assesses the functional, physical, and emotional effects of dizziness on disability over the past month. It consists of 25 questions, 9 functional, 7 physical, and 9 emotional, with three answer options: yes (4 points), sometimes (2 points), and no (0 points). A total score is calculated along with the scores for each subsection. The total score ranges from 0 to 100, with higher scores indicating greater disability. According to the total score, the level of disability is classified as follows: 16-34 points as mild; 36-52 points as moderate; and 54 and above as severe. This scale, whose
Istanbul Mal de Debarquement Scale
Time frame: From enrollment (baseline) until the final follow-up, assessed at multiple time points: baseline, immediately post-treatment (day 5), 1 month, and 1 year.
The scale is composed of subfactors to better assess MdDS. The scale consists of four subfactors: "Diagnostic Criteria" (items 1-5), "Dizziness Character" (items 6-9), "Visual Movement Intolerance" (items 10-12), and "Quality of Life" (items 13-18). The scale was designed using a 5-point Likert-type scale, using the terms "Always," "Frequently," "Sometimes," "Rarely," and "Never." These statements were scored from 5 to 1, respectively. The total scale score was calculated as 100. Permission was obtained from the scale's author for use.
Dizziness Severity
Time frame: From enrollment (baseline) until the final follow-up, assessed at multiple time points: baseline, immediately post-treatment (day 5), 1 month, and 1 year.
Visual Analog Scale: The participant's dizziness intensity was assessed on a scale between 0 and 10-cm line, where 0 represents "no vertigo/dizziness," and 10 represents "extreme dizziness. Scores are categorized as mild (2-3), moderate (4-5), severe (6-7), quite severe (8-9), and extreme.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2025.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared because this is a single-patient case study. Sharing de-identified data could risk patient confidentiality. Summary-level data may be reported in future publications.
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.
Görkem ATA, Ph.D. principal investigator
Medipol University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Optokinetic stimulation in people with Mal de Debarquement Syndrome (MdDS), run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).
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 5 inclusion and 2 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 26 Dec 2025. 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Level of Disability (time frame: From enrollment (baseline) until the final follow-up, assessed at multiple time points: baseline, immediately post-treatment (day 5), 1 month, and 1 year.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Dec 2025.