NCT07304414

Brief 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). 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 24, 2025

Completed
5 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 29, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2025

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

December 8, 2025

Completed
18 days until next milestone

First Posted

Study publicly available on registry

December 26, 2025

Completed
Last Updated

December 26, 2025

Status Verified

December 1, 2025

Enrollment Period

5 days

First QC Date

December 8, 2025

Last Update Submit

December 24, 2025

Conditions

Keywords

mal de debarquement syndromeoptokinetic stimulationdizzinesspostural balancequality of lifevestibular disorders

Outcome Measures

Primary Outcomes (3)

  • 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

    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.

    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.

    From enrollment (baseline) until the final follow-up, assessed at multiple time points: baseline, immediately post-treatment (day 5), 1 month, and 1 year.

Study Arms (1)

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.

Other: Optokinetic stimulation

Interventions

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.

Optokinetic stimulation (OKS) Intervention

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Medipol University

Istanbul, Beykoz, 34810, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Mal de debarquementDizziness

Condition Hierarchy (Ancestors)

Sensation DisordersNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Görkem ATA, Ph.D.

    Medipol University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PT Ph.D.

Study Record Dates

First Submitted

December 8, 2025

First Posted

December 26, 2025

Study Start

October 24, 2025

Primary Completion

October 29, 2025

Study Completion

November 30, 2025

Last Updated

December 26, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

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.

Locations