Developing Robust Treatment Options for Mal de Débarquement Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Change in Subjective severity of MdDS-related Symptoms Self-score
研究概览
简要总结
Mal de Débarquement Syndrome (MdDS) is an under-recognized balance disorder, which is manifested by persistent false sensations of oscillatory self-motion (rocking/swaying) and/or pulling in a specific direction (gravitational pull). Patients with MdDS typically experience additional presumably secondary symptoms, such as heightened sensitivity to visual motion (visually induced dizziness, VID), physical motion (motion sickness, MS), and other debilitating physical, cognitive, or affective problems. MdDS was previously considered intractable, and only recently was a breakthrough made in the clinical laboratory with an introduction of a visual-vestibular therapy protocol, yielding a significant long-term improvement of symptoms, including complete remission, in about 50% of patients. However, the approach is limited in several ways. Firstly, there is a practical limitation in implementing the treatment protocol, which requires a specialized set-up for visual stimulation in a dedicated room. This research will address this limitation by testing the utility of virtual reality technology to implement the treatment protocol. Secondly, patients often retain residual symptoms of VID and MS susceptibility, which often act as a trigger for the recurrence of MdDS. This limitation will be addressed by supplementing the original approach with an additional treatment focusing on VID or MS susceptibility. Thirdly, although the original protocol focused on reducing rocking/swaying sensations, gravitational pull often co-occurs with such sensations, and some experience only that motion sensation. This limitation will be addressed by modifying the original protocol. Two hundred patients with MdDS will be recruited for the study. Bias will be controlled by randomized group assignment and the use of placebo treatments. Patients will be treated for 1-2 hours a day for 5 days. Patients will be followed for up to 6 months. The proposed study will facilitate improved outcomes for MdDS by broadening its treatment options.
详细描述
Objectives This study aims to improve outcomes of MdDS by broadening its treatment options. Specifically, to improve access to the VOR readaptation treatment, the investigators will test the efficacy of VR goggles in generating visual motion to treat MdDS. If proven to be effective, MdDS patients can be treated locally in many vestibular therapy offices, not only for initial treatment but also for remedial or follow-up treatment when symptoms return. To improve long-term outcomes of MdDS, the investigators will evaluate the efficacy of the treatment of a complementary approach combined with VOR readaptation. The investigators hypothesize that an additional intervention that reduces (habituates) the velocity storage capacity will decrease sensitivity to physical movement and improves MdDS symptoms as well as limits symptom recurrence. In addition the investigators hypothesize that desensitization to visual stimuli can reduce visually induced dizziness frequently observed in patients with MdDS. The investigators will verify whether these complementary treatments will provide a better outcome compared to the readaptation treatment by itself. Lastly, to broaden the scope of the VOR readaptation treatment, the study will address the false sensation of gravitational pull commonly reported by patients. The investigators also hypothesize that a visual motion stimulus without cross-axis head motion can reduce this sensation.
Specific Aims Specific Aim 1: Evaluate the efficacy of VR goggles for VOR readaptation. One hundred patients with oscillatory self-motion sensations will be randomly assigned to undergo VOR readaptation with full-field OKS (Group 1, n=50) or VR goggles (Group 2, n=50). Immediate and up to six-month follow-up results will be compared.
Specific Aim 2: Evaluate the efficacy of habituation and visual desensitization combined with VOR readaptation. Sixty patients with oscillatory self-motion sensations will be randomly assigned to undergo VOR readaptation with full-field OKS combined with a habituation (Group 3, n=30) or visual desensitization (Group 4, n=30) protocol. Immediate and up to six-month follow-up results will be compared to those of Group 1.
Specific Aim 3: Treatment of gravitational pull sensation. The investigators estimate that 40 of 200 patients screened for this study will have a phantom sensation dominated by gravity pull, 20 with only that sensation. These patients will be randomly assigned to undergo OKS in a full-field (Group 5, n=20) or VR setting (Group 6, n=20). Immediate and up to six-month follow-up results will be compared.
How Research Will Be Introduced to Participants:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
The group assignment will be based on a random drawing of numbers prepared by Dr. Maruta, to the outcome of which he will be blinded. Dr. Cho (NYU) will interview each participant over the phone prior and at the completion of the final 6-month follow-up to independently record symptom severity scores as reported by the participants. Dr. Cho will be blinded to the type of the treatment that the participants received. Dr. Maruta will perform analyses of objective (posture, rotational test, VNG) and subjective (DHI, SVQ, VVAS, HADS, STAI etc.) data obtained during the treatment and at follow-ups. Dr. Maruta will be blinded to the participants' identity and the type of treatment received.
入排标准
- 年龄范围
- 18 Years 至 78 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Conformable diagnosis of Mal de Débarquement Syndrome including significant improvement of symptoms with passive motion.
排除标准
- •A history of abnormal inner ear or central vestibular function indicated by abnormal nystagmography test (abnormal saccades or pursuit, VOR suppression index <85%, no caloric response, decay time constant of response to rotation less than 10 seconds, spontaneous nystagmus).
- •Confounding neurological disorders (e.g., multiple sclerosis, Parkinson's, epilepsy, blindness etc.).
- •A history of leg, spine, or other injuries that affect their ability to stand or walk without assisting support.
- •High level of anxiety as indicated by State-Trait Anxiety Inventory (≥75) and the Beck Anxiety Inventory (≥55).
- •Claustrophobia.
- •Patients previously treated with VOR readaptation technique are excluded.
研究组 & 干预措施
Group 1: VOR readaptation with full-field OKS
This group to undergo VOR readaptation with full-field OKS. Groups 1 will be treated with stationary OKS (sham). (Group 1, n=50).
干预措施: VOR Readaptation (Behavioral)
Group 2: VOR readaptation with VR googles
This group to undergo VOR readaptation with VR googles. Groups 2 will be treated with stationary OKS (sham). (Group 2, n=50)
干预措施: VOR Habituation (Behavioral)
Group 3: Supplemental VOR habituation
This group to undergo VOR readaptation with full-field OKS combined with a habituation protocol. (Group 3, n=30)
干预措施: VOR Readaptation (Behavioral)
Group 3: Supplemental VOR habituation
This group to undergo VOR readaptation with full-field OKS combined with a habituation protocol. (Group 3, n=30)
干预措施: VOR Habituation (Behavioral)
Group 4: Visual desensitization treatment
This group to undergo VOR readaptation with full-field OKS combined with visual desensitization protocol. (Group 4, n=30)
干预措施: VOR Readaptation (Behavioral)
Group 4: Visual desensitization treatment
This group to undergo VOR readaptation with full-field OKS combined with visual desensitization protocol. (Group 4, n=30)
干预措施: Visual Motion Desensitization (Behavioral)
Group 5: Treatment of gravitational pull with OKS with full-field setting
This group with phantom sensation dominated by gravity pull. This group will undergo OKS in a full-field (Group 5, n=20) .
干预措施: Opposing visual motion stimulus (Behavioral)
Group 6: Treatment of gravitational pull with OKS with VR setting
This group with phantom sensation dominated by gravity pull. This group will undergo OKS in a VR setting (Group 6, n=20).
干预措施: Opposing visual motion stimulus (Behavioral)
结局指标
主要结局
Change in Subjective severity of MdDS-related Symptoms Self-score
时间窗: Baseline and 6 months
The levels of subjective severity of MdDS-related symptoms will be reported on an 11-point Likert scale of 0-10, where 0 is no symptoms, and 10 is the most challenging sensation of that symptom that the patient can imagine. Higher score indicates poorer health outcome.
次要结局
- Change in The Hospital Anxiety and Depression Scale (HADS)(Baseline and 6 months)
- Change in Dizziness Handicap Inventory (DHI)(Baseline and 6 months)
- Postural stability(During 5 days of treatment)
- Change in the State-Trait Anxiety Inventory (STAI)(Baseline and 6 months)
- Change in Visual Vertigo Analogue Scale (VVAS)(Baseline and 6 months)
- Change in Situational Vertigo Questionnaire (SVQ)(Baseline and 6 months)
- Anonymous REDCap survey(At 6-month follow-up)
- Change in Beck Anxiety Inventory (BAI)(Baseline and 6 months)
- Velocity storage time constant(During 5 days of treatment)
- Change in The Vestibular Disorders Activities of Daily Living Scale (VADL)(Baseline and 6 months)
研究者
Sergei Yakushin
Associate Professor
Icahn School of Medicine at Mount Sinai