Status:
RECRUITING
Development, Application, and Mechanistic Investigation of a Novel Minimally-Invasive Bidirectional Epidural Cerebellar Stimulation Technique for Cerebellar Cognitive Affective Syndrome
Lead Sponsor:
Peking University First Hospital
Conditions:
Cerebellar Atrophy
Etiology
Eligibility:
All Genders
18-85 years
Brief 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 Cushi...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 28 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 1 2028
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT07166432
Start Date
June 28 2025
End Date
June 1 2028
Last Update
September 10 2025
Active Locations (1)
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1
Department of Urology, Peking University First Hospital, Beijing, 100034
Beijing, China