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临床试验/NCT07304414
NCT07304414已完成不适用

Clinical Improvement Following Optokinetic Stimulation in Mal de Débarquement Syndrome: A Case Study

Istanbul Medipol University Hospital1 个研究点 分布在 1 个国家目标入组 1 人开始时间: 2025年10月24日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
1
试验地点
1
主要终点
Level of Disability

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

性别
Female
接受健康志愿者

入选标准

  • 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).

排除标准

  • 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

结局指标

主要结局

Level of Disability

时间窗: 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

时间窗: 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

时间窗: 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.

次要结局

未报告次要终点

研究者

发起方
Istanbul Medipol University Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

gorkem ata

PT Ph.D.

Istanbul Medipol University Hospital

研究点 (1)

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