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Clinical Trials in China / NCT07166432
Recruiting Observational

Development, Application, and Mechanistic Investigation of a Novel Minimally-Invasive Bidirectional Epidural Cerebellar Stimulation Technique for Cerebellar Cognitive Affective Syndrome

NCT07166432 · tracked via the Priya Life Science China tracker
Sponsor
Peking University First Hospital
Phase
Observational
Started
2025-06-28
Last updated
2025-09-10

Condition(s) studied

Cerebellar AtrophyEtiologyPhysiopathology

Investigational drug(s) / intervention(s)

observational diagnostic model development

observational diagnostic model development: observational diagnostic model development

Study summary

Building on previous findings regarding microglial immune function and the immunosuppressive effects of glucocorticoids, this project centers on the cerebellum's role in cognitive science. Using Cushing's syndrome-induced cerebellar atrophy leading to CCAS as a model, we aim to elucidate the pathogenic mechanisms governed by the neuro-adrenal-immune network and to uncover the molecular basis by which a novel minimally invasive brain-machine fusion system ameliorates cerebellar ataxia and cognitive impairment.

Eligibility

Sex
ALL
Min age
18 Years
Max age
85 Years
Healthy volunteers
No
Inclusion Criteria: * 1\. Clinically and biochemically confirmed ACTH-dependent or ACTH-independent Cushing syndrome (loss of serum cortisol circadian rhythm, elevated 24-hour urinary free cortisol, and failure to suppress on low-dose dexamethasone suppression test). 2\. Cranial MRI demonstrating unequivocal cerebellar atrophy (CCAS imaging criterion: cerebellar hemisphere or vermian volume ≥1.5 SD below age-matched normative data). 3\. Established clinical diagnosis of CCAS (meets Schmahmann criteria, CCAS-S total score ≥20). 4\. Cerebellar ataxia rating scale (SARATA) ≥10, indicating at least moderate motor ataxia. 5\. Positive cognitive impairment screen (MoCA \<26, or Z-scores ≤-1.5 in at least two cognitive domains). 6\. Willingness to undergo minimally invasive epidural cerebellar stimulation and provision of written informed consent. Exclusion Criteria: Patients with significant systemic disease; occurrence of major complications or irreproducible, critical deviations in data collection or experimental procedures; or any circumstance rendering continued participation inappropriate-including clinical deterioration, serious adverse events, or poor compliance-will result in discontinuation of the subject's enrollment.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Department of Urology, Peking University First Hospital, Beijing, 100034 Beijing China Recruiting

More Peking University First Hospital trials in China

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07166432 on ClinicalTrials.gov ↗ ← All trials in China