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

NCT ID: NCT07166432

Last Updated: 2025-09-10

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-06-28
• Study Completion Date: 2028-06-01

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 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.

Conditions

Cerebellar Atrophy; Etiology; Physiopathology

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

observational diagnostic model development

observational diagnostic model development

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Peking University First Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Department of Urology, Peking University First Hospital, Beijing, 100034

Beijing, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Zheng Zhang

Role: CONTACT

doczhz@aliyun.com

139 0137 1490

Facility Contacts

Zheng Zhang

Role: primary

doczhz@aliyun.com

Other Identifiers

PKUFH-URO-CCAS-2025-MI-BES

Identifier Type: -

Identifier Source: org_study_id