Brain and balance in bilateral vestibular hypofunction: MRI links to symptoms

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a multicenter cross-sectional study enrolling about 120 participants (roughly 80 with BVH and 40 healthy controls) across five centers in China. It uses vestibular tests, neuroimaging (resting-state fMRI, diffusion imaging), and blood and clinical assessments to explore how brain changes correlate with vestibular function and patient-reported outcomes. The goal is to identify clinical and biological factors associated with disease severity and functional impairment. The study will compare BVH patients to age-matched controls to characterize brain networks and microstructure differences related to vestibular loss.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Sex unrestricted, age over 16 years old.
2. Patients meeting the diagnostic criteria for bilateral vestibulopathy (BVP) and presbyvestibulopathy (PVP)
3. Participants or their legal representatives, who comprehensively understand the research purpose, demonstrate sufficient compliance with the study protocol, have the ability to communicate and cooperate, and have signed the informed consent form.

Exclusion Criteria:

1. Administration of medications potentially affecting cerebral function, including psychotropic drugs (antidepressants, anxiolytics) or prolonged anti-vertigo medication usage.
2. Presence of severe cardiovascular or systemic medical conditions, organ dysfunction, or significant mobility impairments.
3. Significant local or systemic diseases, or psychiatric disorders causing cognitive impairment, specifically schizophrenia, major depressive disorder, or generalized anxiety disorder.
4. Pregnant or lactating women.
5. Participation in alternative pharmaceutical or medical device clinical trials within the preceding 3-month period.
6. Clinically significant head movement restrictions.
7. Subjects assessed by investigators as unsuitable for study participation.
8. Individuals with contraindications for MRI, including cardiac pacemakers, implanted electronic devices, claustrophobia, metallic implants incompatible with magnetic resonance imaging and medications potentially compromising MRI scan safety.

Where it's running

• shanghai Jiao Tong University School of Medicine Affiliated Sixth People's Hospital
  Shanghai, Shanghai Municipality, China Recruiting

Study contacts

• Study coordinator: Yuchen Jin, Master of Medicine
• Email: achanjindoctor@163.com
• Phone: +86 17317962393

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.