Tokyo, Oct. 16 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000063292) titled 'Investigation of disease mechanism of chronic dizziness using oculomotor recordings' on Oct. 15.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Non-randomized Blinding - Open -no one is blinded Control - No treatment

Primary Sponsor: Institute - Institute of Science Tokyo

Condition: Condition - MdDS (Mal de Debarquement Syndrome), PPPD (Persistent Postural-Perceptual Dizziness), Chronic unilateral vestibulopathy Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - The primary objective of the present study is to investigate the symptoms and objective physiological findings (ocular movements, posturography) by comparing between MdDS, PPPD, chronic unilateral vestibulopathy and healthy participants.The secondary objective is to observe the whether the effect of readaptation, a method that is used to decrease the symptoms of MdDS, also applies to patients with PPPD and chronic unilateral vestibulopathy, while analyzing the physiological response including spatial orientation and vestibular adaptation during the readaptation stimulation. The present study is exploratory, and aims to obtain the baseline findings in order to understand the pathological mechanism of chronic dizziness, and to build the foundation for future research on treatment of MdDS and PPPD. Basic objectives2 - Safety,Efficacy

Intervention: Interventions/Control_1 - Regarding MdDS patients, Oculomotor recordings such as spontaneous nystagmus, Listing Plane determination, cross-coupling, vergence. Time constant of vestibule-ocular reflex using rotational chair test, posturography Oculomotor recordings during readaptation stimulation. Participant will be asked to visit for 1-2 hours, four times per month for 1 or 2 months duration. Interventions/Control_2 - Regarding PPPD patients, Oculomotor recordings such as spontaneous nystagmus, Listing Plane determination, cross-coupling, vergence. Time constant of vestibule-ocular reflex using rotational chair test, posturography Oculomotor recordings during readaptation stimulation. Participant will be asked to visit for 1-2 hours, four times per month for 1 or 2 months duration.

Eligibility: Age-lower limit - 18 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - MdDS group - outpatient, fulfills the Barany diagnostic criteria of MdDS PPPD - outpatient, fulfills the Barany diagnostic criteria of PPPD with NPQ of 27 points and above, and NPQ visual score of 9 points and above Chronic unilateral vestibulopathy - outpatient, with one-sided vestibular impairment as evidenced by more than 25% of canal paresis during caloric stimulation, or maximum eye velocity of less than 6 degrees per second, or video hit impulse with gain of 0.7 or less, or asymmetry ratio of 0.3 or more. Does not fulfill the Barany society criteria of MdDS or PPPD and NPQ is less than 27 with NPQ visual score of less than 8. Healthy participant - no known inner ear or central pathologies. Age and sex-matched to MdDS group. Key exclusion criteria - -A history of neurological or cranial nerve disorders -Any disease or condition that prevents the neck movements required for the study -Corrected visual acuity of 0.1 or worse on the decimal scale (eyeglasses cannot be worn with the VR headset used in this study) -Inability to report or communicate subjective symptoms, including due to cognitive impairment -Photosensitive epilepsy -Failure to achieve at least 50% fixation suppression of nystagmus -Any other condition that, in the judgment of the principal investigator or a physician serving as a co-investigator, makes participation inappropriate Target Size - 80

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 10 Month 15 Day Anticipated trial start date - 2026 Year 11 Month 30 Day Last follow-up date - 2028 Year 11 Month 30 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072444

Disclaimer: Curated by HT Syndication.