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

NCT07166432 | Recruiting DMC

• 1 other identifier: PKUFH-URO-CCAS-2025-MI-BES
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

observational diagnostic model development OTHER

observational diagnostic model development

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients aged 18-80 years who have documented hypercortisolism (Cushing syndrome) on clinical testing and are assessed as having decision-making capacity.

You may qualify if:

• \. 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).
• \. Cranial MRI demonstrating unequivocal cerebellar atrophy (CCAS imaging criterion: cerebellar hemisphere or vermian volume ≥1.5 SD below age-matched normative data).
• \. Established clinical diagnosis of CCAS (meets Schmahmann criteria, CCAS-S total score ≥20).
• \. Cerebellar ataxia rating scale (SARATA) ≥10, indicating at least moderate motor ataxia.
• \. Positive cognitive impairment screen (MoCA \<26, or Z-scores ≤-1.5 in at least two cognitive domains).
• \. Willingness to undergo minimally invasive epidural cerebellar stimulation and provision of written informed consent.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking University First Hospital: lead

Study Sites (1)

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

Beijing, China

RECRUITING

Central Study Contacts

Zheng Zhang

CONTACT

139 0137 1490; doczhz@aliyun.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 3, 2025
• First Posted: September 10, 2025
• Study Start: June 28, 2025
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 1, 2028
• Last Updated: September 10, 2025

Record last verified: 2025-06

Locations

CN (1)