Development, Application, and Mechanistic Investigation of a Novel Minimally-Invasive Bidirectional Epidural Cerebellar Stimulation Technique for Cerebellar Cognitive Affective Syndrome
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)
A "dual clinical response" at 12 weeks post-treatment, defined as a ≥5-point improvement in the Cerebellar Cognitive Affective Syndrome Scale (CCAS-S) total score AND a ≥6-point improvement in the Scale for Assessment and Rating of Ataxia (SARATA) total — from 2025 to 2028
Trial sites (1)
Facility
City
Region
Status
Department of Urology, Peking University First Hospital, Beijing, 100034
Beijing
China
Recruiting
More Peking University First Hospital trials in China
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.
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