DevRobust Treatment for Mal de Débarquement Syndrome

ID#: NCT05460520

Age: 18 - 78 years

Gender: All

Healthy Subjects: No

Study Phase: N/A

Recruitment Status: Recruiting

Start Date: October 01, 2022

End Date: August 01, 2027

Contact Information:
Sergei Yakushin, PhD
(212) 241-9349
Jun Maruta, PhD
(212) 241-7068
Summary: 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.
Eligibility:

Inclusion Criteria:

- Conformable diagnosis of Mal de Débarquement Syndrome including significant improvement of symptoms with passive motion.

Exclusion Criteria:

- 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.
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